Quality Requirements for Clinical Applications

This assignment examines the critical quality requirements essential for successful clinical application of pharmaceuticals. It delves into topics such as continuous manufacturing technologies, responses to contamination crises (like the heparin incident), GMP standards for recombinant adeno-associated viral vectors, and diagnostic allergens used in allergy diagnosis. The discussion also covers additively manufactured medical products, radiolabeling practices for clinical use, pharmaceutical quality by design, and regulatory oversight by agencies like the FDA. Furthermore, it touches on pharmacy practice competencies and the integration of wireless sensor networks with statistical quality control in cold chain systems.

Quality Assurance & Good
Manufacturing Practices

Table of Contents
INTRODUCTION...........................................................................................................................1
PART 1............................................................................................................................................1
Section A.....................................................................................................................................1
Section B.....................................................................................................................................1
1. Tests for the effectiveness of the antimicrobial preservatives................................................1
2. Different phases of teratogenic activity testing.......................................................................2
3. Difference between accuracy and precision............................................................................2
4. What are the different types of glass used in pharmaceutical manufacturing and discuss
their chemical resistance test.......................................................................................................3
5. Bracketing design for testing the new drug substance............................................................4
6.short note on following tests:...................................................................................................4
7. Describe the storage condition and testing frequency for long term and accelerated stability
study of the drug substance.........................................................................................................5
8. Why is the testing of Bacteriostasis and fungi stasis carried out before sterility testing.
Describe the inoculation method.................................................................................................6
9. Explain the ICH guideline for stability testing for new drugs................................................6
10. Describe the microbiological limit test for the Pseudomonas aeruginosa............................7
11. Explain quality control test for Metal containers, paper, paper boards and cardboards as
packaging material......................................................................................................................7
12. What is acute toxicity and what is the need of acute toxicity testing....................................8
13. Describe the pyrogen test for quality control testing of parenteral products........................9
14. Explain WHO guidelines for ongoing stability study for active pharmaceutical ingredients.
What is significant change..........................................................................................................9
15. Describe the physical test for the quality control testing of ointments...............................10
Section C...................................................................................................................................10
1. Describe the Bioanalytical method validation and the parameters involved........................10
2. Detail Note on ICH guidelines for photo stability study for new drugs and substance
product. .....................................................................................................................................11
3. OECD guidelines for chronic toxicity...................................................................................11

4.) List various packaging material of pharmaceutical industry and quality test for plastics.. .12
5. What is mutagenicity and its various tests............................................................................12
PART 2..........................................................................................................................................12
Quality Testing Tools and Techniques..........................................................................................12
Section A........................................................................................................................................12
1. P values> 0.05:......................................................................................................................12
2. ANOVA is an example of:....................................................................................................12
3. Test used in ANOVA............................................................................................................13
4. D) Non Bliend trial................................................................................................................13
5. A) RCT..................................................................................................................................13
Section B........................................................................................................................................13
1. Meaning of biostatistics and various related terms...............................................................13
2. Point estimation.....................................................................................................................13
3. Difference between statistical significance and P-values.....................................................14
4. T-test and differences between paired and unpaired test......................................................14
5. Hypothesis testing.................................................................................................................15
6. Differences between Pearson's Correlation Coefficient and Spearman's Correlation
Coefficient.................................................................................................................................15
7. Analysis of means and comparison of correlation with regression.......................................16
8. Explain:.................................................................................................................................16
9) What is meta analysis and how it is performed....................................................................17
10. SAS sorfware and its advantage over other........................................................................17
11. How to create scatter plot using minitab.............................................................................17
12. Enlist and explain various plots used in statistics...............................................................18
13. Difference between parametric and non para metric test and the type of data obtained from
it.................................................................................................................................................18
14. Enlist software's used for T test and T test in excel............................................................18
15. Difference between F test and Z test...................................................................................19
Section C...................................................................................................................................19
1. Different non parametric test used in statistics.....................................................................19
2. Explain RCT..........................................................................................................................19

3. Explain Graph pad prism software........................................................................................19
4. What is measurement of central tendencies and dispersion. Explain interval estimation.....20
5. Different types and advantage and disadvantage of Adaptive design and quasi experimental
design........................................................................................................................................20
PART 3..........................................................................................................................................21
Ques 1. Efficacy Guidelines no. E-2C (R2) and E 2A .............................................................21
Ques 2 Responsibilities of Investigator during clinical trials...................................................21
Ques 3. GCP..............................................................................................................................22
Ques 4 Roles and responsibilities of IRB.................................................................................22
Ques 5 Several certificates which are to be issued under WHO on quality of Pharamaceutical
products.....................................................................................................................................23
Ques 6 GCLP............................................................................................................................23
Ques 7 CAPA............................................................................................................................23
Ques 8. Meaning of Following Term:.......................................................................................24
Ques 9 Deviation Handling under Quality management system..............................................24
Ques 10 Guidelines no. S1 A and S3 A for safety....................................................................25
Ques.11 Guideline E3 related to structure as well as content of clinical study report.............25
Ques 12. Meaning of CTD.......................................................................................................26
Ques 13 Roles as well as responsibilities of sponsors in clinical trials....................................26
Ques 14 Documents that are to be prepared before the execution of clinical study ................27
Ques 15. Guideline no. ICHQ 10..............................................................................................27
SECTION C...................................................................................................................................28
Ques 1 Quality management system.........................................................................................28
Ques. 2 Clinical Trial protocol .................................................................................................30
3. How the quality can be assured in clinical research.............................................................31
4. Seven steps of CAPA in pharmaceutical industry................................................................31
5. Explain ICH Tripartite Guideline ODF Quality risk management (Q9)...............................32
CONCLUSION..............................................................................................................................32
REFERENCES..............................................................................................................................33

INTRODUCTION
The better quality management and manufacturing practices is very necessary that helps
in the better productivity and profitability. The better quality will help a business organisation in
gaining an effective customer satisfaction level. This report will cover the better microbial part
and its effectiveness, the difference between precision and accuracy and different pharmaceutical
packaging material is been taken into consideration (Newton And et.al., 2015. ). Various stability
testing are been taken into consideration and ICH guidelines are been taken in effective
consideration. Apart from this, the acute toxicity and its various tests are been discussed. The
WHO guidelines are been discussed. Other than this the various bio analytical measures are been
taken into effective consideration with OECD guidelines are been discussed.
PART 1
Section A
2. C) Pseudomonas aeruginosa
3. D) Photo stability testing of the new drugs or substance.
4. D) 14 Days
5. C) Weight Variation test.
6. C) 8.5 ml
Section B
1. Tests for the effectiveness of the antimicrobial preservatives.
The antimicrobial preservatives are very necessary and vital in the pharmaceutical
industry as it helps in the safeguarding the life saving drugs from getting contaminated. This will
help in producing and manufacturing the high quality drugs and medicines to customers. The
antimicrobial preservatives will protect the medicines and various types of drugs from the getting
affected by the microorganisms and keep the medicine sterile and viable in various
environmental condition (Haleem And et.al., 2015). The major function of the antimicrobial
preservative is to prevent the growth of the bacteria and other contaminations in the vital drugs
and medicines. This will help the customers to get the safe and high quality drugs and
medications in a very effective way.

Such preservatives are added in almost every sort of the drugs and medicines including
the parenteral otic, nasal, ophthalmologic, oral and topical sort of drugs in solid and aqueous
bases. It helps in gaining the better handling of the different operations which helps in the
effective handling of the various operations. It helps in increasing the shelf life of the drugs and
medicines and reduces the constraint of the temperature specific storing of the medications at a
clinic or pharmaceutical shop. This it helps in maintain the quality of drugs for prolonged period
(Alli, 2016).
2. Different phases of teratogenic activity testing
The teratogens are the effective chemical or drugs that lead to the severe toxicity and
inhibition in the body. The effective testing of the toxic material is very necessary for the
safeguarding the life of an individual. The presence or the consumption of any sort of teratogenic
component like alcohol or other chemical may lead to the rise in the toxicity of the individual,
which may lead to the severe consequences. The testing involves the various phases such as:
 Animal test system: This involves the testing of the teratogen drugs on the animals to
understand its consequences on the human body.
 Whole Embryo culture test: It involves the process of culturing or growing of embryo
of an animal like frog or mouse to carry out the teratogenic compounds and its
implication on user.
3. Difference between accuracy and precision
The accuracy and provision plays a very vital and crucial role in the maintaining and
developing of the proper product or service. In the pharmaceutical field, the accuracy and
precision plays a very crucial and vital role in development of the high quality product and
services (Nally, 2016.). The major difference between accuracy and precision is as follows:
Accuracy Precision
Accuracy indicates the difference between the
measurements set and the actual value
achieved.
Precision is the variation that is visible when
the value is measured from the same device,
again and again.
It indicates the closeness of the value achieved It indicates the measure that how closely the

from the value that is been set in the target. results agree with each other.
It is dependent on the degree of confirmation
of achievement of exact result.
This is dependent of the degree of the
reproducibility in an organisation.
It is dependent on single factor of the
execution.
This is affected by the various factors that can
impact the precision to get the desired
productivity.
Its measurement is statically biased and is
based on the target that is been set.
This may contain the statically variability
every time it is been measured (Allison and
et.al., 2015).
It gets impacted by the systematic errors
occurring during measurement.
Precision is deeply effected by the random
error caused during the measurement of the
output or result.
4. What are the different types of glass used in pharmaceutical manufacturing and discuss their
chemical resistance test.
The pharmaceutical industry uses a wide variety of apparatus to manufacture and test the
various medication's. They use various quality and composition of glass that is used for the
various medical operations and manufacturing purposes. Some major glasses used in
pharmaceutical industry to get better quality are:
Parenteral Use
Type I Glass:
Highly resistant borosilicate glass: It is used for high number of buffered and non buffered
aqueous solution and is most popular and widely used glass type.
Type II Glass:
Highly resistant Sodalime Glass: It is used for the aqueous solution of the medications and
chemical which are acidic in nature and have ph value lower than 7.0.
Type III Glass:

Moderately resistant Sodalime Glass: It is mostly used for the less reactive medications having
the tangibility of dry powder form or as oily solution (Parikh, 2016).
Non Parenteral Use
Type IV Glass:
General purpose Sodalime Glass: It is used for the non parenteral purposes and utilised for the
tablets, oral medications and other external drugs.
Various evaluation parameters are been taken into the effective consideration for the
better testing of the Glass components that are been used in the pharmaceutical industry. Some
major tests that are been followed are:
 Crushed glass test: The container is well crushed and the sieved to get the uniform
particles. A definite quantity of mixture is taken and is treated with the various solutions
to test is reactivity with the various solutions. This helps to determine that the glass is
treated or not.
 Whole container test: In this, the complete apparatus is been tested for its tensile
strngth, reactivity and smoothness in order to use it effectively for the various
pharmaceutical functions in manufacturing of high quality medications (Lee, and et.al.,
2015).
5. Bracketing design for testing the new drug substance.
The bracketing and matrix design function is used to reduce the sample size of the drugs
or the medication that is been used by the pharmaceutical organisation for the testing the
reactiveness and stability of the drugs in various chemical composition. It helps in getting the
appropriate output and reducing the wastage of the medication that is been produced and
manufactured. It reduces the number of sample size required to get the appropriate output. It
helps in getting the effective data about the estimated shelf life of a drug. It helps in the better
testing of the batches of the smaller quantity of different drugs and medicines. The stability
owning samples are been effectively used to have a better productivity and revenue generation
(Govindaraghavan and Sucher, 2015).
The samples are effectively manufactured, labelled ad stored, reducing the number of the
sample required for testing and thus saves the production and management cost as the production

and storage cost of the various drugs and medicines are quite high and expensive. The bracketing
will help in the better handling of the production design, setting up of goals and improve the
product quality. It involves the following of the various factors such as strength and package
size. And get the better stability of the various drugs on the intermediate level (Vives, Oliver-
Vila and Pla, 2015).
6.short note on following tests:
1) Self Sealability test for closures: It is the effective test that is been used to test the
various drugs, medications and apparatus that are been produced by the pharmaceutical
institution. It helps in the better testing of the various closures which are intended to be
used with the water close the vials with the prepared closures. For each closure test, a
new hypodermic needle of external diameter at 0.8 mm is used. It will pierce the closure
for about 10 times, each time at a different site. Then this vial is immersed in 0.1% w/v
solution of methylene Blue and the external pressure is reduced by 27KPa for some time
(Allison and et.al., 2017). Then the atmospheric pressures is restored and the vials are
been left into the solution for some time. After this, the externals of the vials are been
rinsed. The vial will not have any traces of the coloured solution.
2) Disintegration test for tablets: It is been conducted to test the disintegration of a tablet
or a capsule, when placed in a liquid medium under the experimental condition. The
purpose of this disintegration process is not to imply the complete dissolution f the
constituent part of the tablet or even its active constituent particles. It will not be used to
have the proper or complete solution of the various components of the medicine. It may
involve the soft mass of the constituent particle, with no palpable firm core. This will
help in the better rise in the productivity and profitability of the company and have the
better understanding of the various impact of the medication (Felix, C.W., 2018).
7. Describe the storage condition and testing frequency for long term and accelerated stability
study of the drug substance.
The effective storage and testing frequency is needed to be taken into effective
consideration for the better handling of the various operations at a pharmaceutical company.
These are as follows:

 Testing frequency: To facilitate the effective long term understanding of the operations
to gain a better productivity by having a better knowledge of the stability profiler of
active pharmaceutical ingredient (API). The average shelf life of an API is 12 months
that will help in the effective long term storage condition (Cusato and et.al., 2014). The
components can be retested and can be expanded to the shelf life of the various
operations in a better way. This includes the initial and final time points and requires a 6
month study for the better understanding of the different operations. It helps in getting the
effective change criteria. The change in the sample can be made either by the adding
them in the final point and have a better study design on a regular interval. This process
may involve the minimum of 4 time points including the initial and final time points for
example on 0,6,9 and 12 months regularly in a one year process (Doe, 2017).
 Storage conditions: An API is usually tested in the evaluated storage condition of an
organisation with appropriate tolerable conditions. It involves the testing of the thermal
stability and the sensitivity towards moisture. The length of the testing must be sufficient
to cover the shipment and storage of the medication in a very effective way. The storage
condition must be able to compensate the temperature variation and environmental
changes to increase the stability of the API. It must also involve the test period which is
used for the assessment of the medication manufactured by the pharmaceutical firm to
maintain its quality (Fries, 2016).
8. Why is the testing of Bacteriostasis and fungi stasis carried out before sterility testing.
Describe the inoculation method.
The bacteriostasis and fungi stasis is been effectively carried out before the sterility
testing as it will help in the better detection of the presence of any bacteria, fungus or other
microorganisms in the API or the medication. This will help in the better identification and
taking of the different measures to meet the sterility standard of the medication. The sterile
distribution of the medication is very necessary as it helps in the better management of the
different operations which will help in the better productivity. Besides this, the presence of the
bacteria or fungus in the medication is the indication of presence of contamination which can
have harmful consequences and deteriorate the quality of product (Luthringer And et.al., 2015).

The inoculation process involves the proper induction of the artificial immunity against a
disease or a microorganism, to prevent any sort of infection to the user. It is been induced in the
persons body in the form of vaccination that will help in building a better resistance against an
infection or disease. The introduction of the microorganism in body will lead the immunity
system of body to produce antibodies against them, improving the immunity. Also, it will help in
rise of the production of the sterile medications or vaccinations of better quality by a
pharmaceutical institution (Aung and Chang, 2014).
9. Explain the ICH guideline for stability testing for new drugs
The International Conference of Harmonisation (ICH) has developed the effective
guidelines and measures that helps in the better handling of the different operations and measures
that will help in the better handling of the different operations of various medications and drugs
(Clegg and Perry, 2017).
It involves the various measures that will help in the better handling of the different
operations at the pharmaceutical institution such as:
 The proper storing temperature for the drugs and medications is below 30° C.
 The sample taken from the batch of the medication must be sterile and free from any sort
of contamination, in order to retain the quality.
 The exposed or contaminated drugs must be disposed off immediately in order to prevent
any sort of severe consequences.
 No alterations or other illegal methods should be used to gain a better productivity and
profitability in a better way (Webster, Castellano and Onuma, 2017).
 The packaging must be effectively done in order to avoid any sort of wastage or
contamination.
 The manufacturing and expiry dates must be inscribed on the drug or medication and
must be disposed off in a better way to prevent any misuse of drugs.
 The drug must be properly tested and effective instructions must be provided with it
regarding its effective usage or consumption of the drug or the medicine.

10. Describe the microbiological limit test for the Pseudomonas aeruginosa
This test is been conducted to gain a better productivity and identify the presence of a
microbial organism that can cause Pseudomonas aeruginosa. The specimen of the pharmaceutical
item is been effectively collected for the limit testing. Then the specimen is well incubated to see
the extent or limit of microbial growth in the sample. The sample is thermostatically kept of a
room temperature ideal for the microbial growth i.e. 24° to 35° C for about 24 to 48 hours. This
will show case effectively the various operational quality measures and help the pharmaceutical
firm to identify whether the sample is meeting the quality standards or not (Cole And et.al.,
2017).
11. Explain quality control test for Metal containers, paper, paper boards and cardboards as
packaging material
Various tests are been run over the different components or items, that can be used as the
packaging material for the drugs and medications. This will involve the variety of tests such as:
 Spectrophotometry: It involves the better process where the intensity of the light is been
taken into effective consideration depending of the amount absorbed by the solution or
chemical drug. It is based on the principle that compounds absorbs the light of certain
wavelength.
 Chromatographic Methods: the chromatography method is a measure to test separation
of the compounds. The material used for the packaging of the drugs and medications
must be safe to use and prevent chromatographic segregation of a solution in a drug or
medication (Altenstetter, 2017).
 Thermal analysis techniques: it is the test to identify the impact of the temperature on
an item that is used as the packaging material for the drugs or medication. The element
must be abler to withstand the change in the temperature or other environmental factors
in a better way.
 Leak detection: the material used for the storing and packaging of drugs is required to be
leak proof to avoid the spoiling and wastage of drug or medication.

12. What is acute toxicity and what is the need of acute toxicity testing.
Acute toxicity is the side effects caused by short term exposure to a medication and lay a
negative impact on the health of an individual. It is the form of reaction or symptoms that occur
after the overuse or misuse of a drug or medication. This may lead to the severe consequences. It
can come into contact by the means of direct exposure, accidental exposure or drug testing. This
is required to be taken into immediate consideration that helps in the effective handling of
different operations or symptoms caused due to toxicity (Mendelson and et.al., 2016). The
symptoms of the acute toxicity is deeply based on the extent of exposure, its duration and the
immunity or resistivity of the person.
The effective testing of the acute toxicity is very necessary. The effective testing will
help in the better handling of the different operations to identify the impact of a single substance
or drug on the individual. It will help in the identification of lethal limit of a medication or drug
that helps in the effective management of toxicity of various drugs in a person (Todd And et.al.,
2014). The toxicity of a drug is been tested on animals before the human usage. This is done to
safe guard the lives of human beings and protect them from the adverse or negative impact of a
drug or medication.
13. Describe the pyrogen test for quality control testing of parenteral products.
The pyrogen test is been done to find the toxicity level of a drug or medication that helps
in the better handling of the different operations that will help in the increase in productivity and
profitability of an organisation. Besides this, it will help in effective safeguarding of an
individual from adverse effect of a drug or medication. It involves the following processes:
 The initial measurement of a specimen animal for example rabbit is been taken before
inducing the drugs into its body.
 Then the In vitro injection of a sterile solution of drug will be given through the vein of
ear. The dose will include 10 ml of sterile solution, at every 10 minute.
 The raise in body temperature will be recorded after every dose (Russell, 2017).

14. Explain WHO guidelines for ongoing stability study for active pharmaceutical ingredients.
What is significant change.
The World Health Organisation (WHO) have set various guidelines that help in
the effective handling of stability of a drug or medication. Some guidelines are as follows:
 Container closure system: It will see through the various measure to look after the
effective handling and packaging of various drugs and medication's. The proper storage
or containing of the drugs or medication will help in better handling and controlling of
various measures which will help in effective rise in productivity and effective handling
of stability testing. It involves the effective packaging of drugs or medication.
 Testing frequency: the drugs or the medications should be tested on the regular basis to
identify and sustain their stability. This will help in identification of proper stability of a
batch or sampler of drug at pharmaceutical institution (Guthman, 2014).
 Storage condition: The storage condition must be appropriate to ensure the prevention of
wastage and misuse of drugs and handle them in an effective and significant manner to
sustain the quality at a pharmaceutical firm.
The 'Significant change' is the effective alteration that which will help in better handling
of different operations which will help in better growth of a pharmaceutical institution. Other
than this, the alterations or modifications which are been made in the product or service to meet
the satisfaction level of the users and customers (Rantanen and Khinast, 2015).
15. Describe the physical test for the quality control testing of ointments.
Various tests are been taken into consideration to identify the quality of an ointment or
tropical medicine. Some major tests are as follows:
 Physical testing: it includes the identification of various factors such as appearance,
development of granular mass, change in viscosity and presence of any contamination.
 Weight variation: This will help in the better handling of the different operations to
determine the change in weight or a sample or topical ointment.
 Solubility test: The sample is been prepared by dissolving the sample of the ointment in
a solvent of ether or alcohol to form a solution and find its stability (Starr, 2015).

Section C
1. Describe the Bioanalytical method validation and the parameters involved.
The effective bioanalytical method validation is very necessary as it helps in better
identification of various biological measures that can be followed to get a better idea of various
solution or the drugs and medications that are been developed by a pharmaceutical firm. It is
used to get the effective analysis of drugs and metabolites or biomarkers. It is very important for
a successful conduct of non clinical or biopharmaceutic study. The validation process that is
been used for quantitative measures of analytics in a given biological matrix like blood, plasma,
serum or urine. These helps in better growth of reliability and reproducibility of a drug as well as
a pharmaceutical organisation (Gogou and et.al., 2015). This involves this following factors or
parameters, which are been taken into effective considerations for the better growth of the drug
producing firm:
 Accuracy: The validation process will help in better handling of the pharmaceutical
processes that will help in effective execution of various operations to develop high
quality drugs and medications.
 Precision: The presence of precision will lead to rise in efficiency of a firm and will help
it to produce and manufacture high quality drugs and medications, with appropriate
statistics and measurement, to avoid the misuse or wastage of any sort of resource. The
maintaining the parameter of precision will help a pharmaceutical firm to produce and
manufacture better medications of good attribute.
 Selectivity: The parameter or measure of selectivity will help in effective evolution of
high quality drugs and medications by the firm. The selectivity will involve the choosing
of proper production and manufacturing measure along with the raw material that will
help in better understanding of various operation's which will help in effective
management of bioanalytical process to maintain the quality standards of firm (Chan,
Zhang and Lin, 2015).
 Reproducibility: It is the process to give high quality products and services on a constant
basis. The better re productivity will help in gaining a sustainability and effective

customer satisfaction level. This will help in good adaption of various processes to
produce high quality drugs and services.
 Stability: The stability is the parameter to test the effectiveness of a drug and its impact
on the user after the dosage of the appropriate quantity and quality. The effective
monitoring of the parameter of stability is required to be taken in consideration to prevent
the acute toxicity and any other adverse effect on the user or patient (Fox, Cogan and
Guinee, 2017).
2. Detail Note on ICH guidelines for photo stability study for new drugs and substance product.
The ICH has set up a some guidelines that have effectively impacted the different
operations of a pharmaceutical firm to develop the drugs and medications in a better and
effective way. Some effective measures that are to be followed are:
 The medication should be properly tested to determine its stability.
 The Misuse and inefficient handling of the drugs should be avoided.
 Proper packaging and manufacturing material is required to be used.
 The effecting batching or sampling should be done for the testing of drugs (Ricordi and
et.al., 2016).
3. OECD guidelines for chronic toxicity
The OECD guidelines for chronic toxicity include the following parameters:
 The drug responsible for the toxicity in the people cannot be further continued to be
usage by humans.
 The metabolism decreasing drugs will be discontinued in the system.
 The absorption rate of medicine in one species gastrointestinal tract is low as compared to
others.
4.) List various packaging material of pharmaceutical industry and quality test for plastics.
Different types of packaging material is used in pharmaceutical industry to package the
drugs and medicines like glass, metal, plastic and paper. Besides this, some tests for quality
measures of plastic are as follows:
 Shock test
 Vibration test

 Drop test
 inclined impact test
 Revolving drum test
5. What is mutagenicity and its various tests.
Mutagenicity is the presence of bacteria or other micro organisms in a sample that is
required to be taken into consideration to identify the extent of exposure (Demirci, Soon and
Wallace, 2016). Some tests for it are:
 Ames Test: It includes pour plate method.
 Muta Chromo plate test: It involves to test the no pre exposure to bacteria.
 Modified ISO: It helps in testing the drugs after the exposure to bacteria for 30 to 100
minutes.
PART 2
Quality Testing Tools and Techniques
Section A
1. P values> 0.05:
B) Statistically insignificant
2. ANOVA is an example of:
A) Parametric test
3. Test used in ANOVA
4. D) Non Bliend trial.
5. A) RCT
Section B
1. Meaning of biostatistics and various related terms
Biostatistics is used to deal with living organisms in effective way. Biostatisticians lays
emphasis on quantitative skills to team of surgeons, cancer specialists and other doctors.
Designing studies are taken in order to have required data and as such, correct information can
be gathered in the best possible way. Biostatistics is mixed aspect of medical science and
statistical tools which are essentially required in this line. There are qualitative and quantitative
data which are required in order to gain information quite effectually (Martins and et.al., 2016).

Quantitative data is arrived by measurements or counts and basically, this data is based on
numerical basis. On the other hand, qualitative data is arrived on the basis of individuals falling
under separate categorises such as sex or diagnose is made.
Furthermore, accuracy and precision of data and variables are required in biostatistics.
Accuracy means that true value is much close to obtained one. In this aspect, true value is also
known as theoretical value. Precision means that how two value are closed in accordance to
measurement in the best possible way. Thus, there is direct correlation between precision and
accuracy of data and variables in biostatistics (Price, 2017).
2. Point estimation
Point estimation is quite useful technique of statistics which is based on finding out
approximate value of statistical tool such as mean. Random samples are taken in order to assess
accuracy of population and draw out sample which is a representative of whole population. Point
estimation is considered to be desirable when population size is large enough. The main reason
behind is that more data will be utilised, more accurate results will be obtained with much ease.
For calculating point estimation, there are various methods used in this aspect (Wongprawmas,
Canavari and Waisarayutt, 2015).
Maximum likelihood method is among them. This method uses calculus to assess
probability function of sample parameters in effectual way. Another one is moments method
which makes equal sample moments to that of population moments. Bayesian method also used
named after Thomas Bayes and it is based on introducing frequency function for estimated
parameter in the best possible way. Next method is named as Best Unbiased Estimators which
implies that unbiased estimators may be used to estimate parameter in the best possible way.
Thus, the best parameter is identified with much ease. Hence, point estimation and its methods
are quite essential in statistics.
3. Difference between statistical significance and P-values
Statistical significance P-values
1. Statistical significance is numeric which is
greater or equal then function of test and
1. P-value is minimum significance level to
reject test on the basis of null hypothesis

among values, when null hypothesis is true. obtained from the data.
2. Statistical significance is also tended to be
size of test as numbers are either greater or
equal then power function (Pirnay And et.al.,
2015).
2. P-value is basically known as size of test.
The main reason behind is that both values are
minimum of significance level.
3. Significance level is not known to be
practical significance in the context of
statistics.
3. P-value is quite effective in comparison of
two values in effective manner. Thus,
difference can be analysed in samples with
much ease.
4. This technique is not based on threshold on
small value to reject null hypothesis.
4. This technique is based on probability when
statistical difference is below level of
significance.
5. Statistical difference is based on the concept
that difference obtained is real and not on
chance basis.
5. P-value is based on probability and as such,
it is dependent upon level of significance
(Vozikis and et.al., 2016).
4. T-test and differences between paired and unpaired test
T-test is used for conducting test on relatively small sample size. Statisticians use this test
for assessing two population variances with much ease. This test is used when difference of
sample variances are not known particularly in normal distributions. In contrary to this, for
testing more than three variables, ANOVA technique is used by the statisticians to attain better
results with much ease. T-test is based on calculating ratio and there are two portions such as
upper half and lower one (Torre And et.al., 2014). The upper one is quite easy to identify as it is
based on averages of two samples. While, other portion is based on measurement of dispersion
and variation among variables. Thus, these are quite useful for attaining results.
Paired test Unpaired test

1. It compares study subject for two different
times.
1. On the other hand, unpaired test is based on
comparison of two different subjects.
2. Paired test has wider scope than unpaired
test in statistics.
2. It has smaller scope in comparison to paired
test.
3. Paired test is more powerful as it reduces
subject variations and as such, it is quite useful
for analysing differences (Baxendale And
et.al., 2015).
3. This test is less powerful as compared to
other one.
5. Hypothesis testing
Hypothesis testing is quite useful in statistics as it help researcher to test assumption with
reference to parameters based on population in effective way. The data is gathered by the
analysts and as such, it assumes regarding population and test parameters in the best possible
manner. Generally, hypothesis is carried out from the large sample to apply research and as such,
results are derived in the best possible manner. This test is done with the perspective either to
accept null hypothesis or to reject the same. When hypothesis test is rejected, then it implies that
assumption regarding the test is not true and it provides results with much ease (Szajek And
et.al., 2016).
Classification of hypothesis is based on Multiple Testing and Bayesian Hypothesis
Testing. Multiple testing classification occurs when there are variety of problems and fields in
the best possible way. This helps to test data on simultaneous basis and thus, test is effectively
carried out with much ease. Bayesian Hypothesis Testing is based on the principle that
probabilities are taken and as such, null hypothesis is applied on it. The results derived are
classified as hypothesis with high probability are accepted and on the contrary, low probability is
rejected. Thus, effective conclusion is obtained in the best possible way (Clément and Grieger,
2016).
6. Differences between Pearson's Correlation Coefficient and Spearman's Correlation Coefficient
Pearson's Correlation Coefficient Spearman's Correlation Coefficient

1. This correlation coefficient technique
outlined by Pearson is based on linear
relationship between continuous variables
under study. Generally, this is carried out on
two variables by analyst.
1. Spearman's Correlation Coefficient is based
on the concept of monotonic relationship
between variables under study. This is also
carried out on two continuous variables in
effective way.
2. Linear relationship adopted by this
technique states when one variable undergoes
change, then, proportionate change is seen on
other variable as well. Thus, it has a linear
relationship (Klimek and et.al., 2015).
2. Monotonic relationship applied in this
method states that two variables undergoes
changes but not proportionately. Both of them
changes not a constant rate. Monotonic
relationship is extracted.
3. It is not based on assessing relationship
between ordinal variables.
3. This method is used to study relationships
involving ordinal variables.
4. The correlation coefficient value ranges
from -1 to +1.
4. The value also ranges in the parameter
defined by Pearson's Correlation Coefficient
(Di Prima and et.al., 2015).
7. Analysis of means and comparison of correlation with regression
Analysis of means is useful statistical tool for studying variations with reference to
various group of data in the best possible way. The abbreviation of this technique is ANOM and
is usually implemented in order to check quality in manufacturing sector. It helps in gaining the
better idea about the various means known as grand mean and helps in better distribution of
resources and information. The correlation process will help in maintaining of better measures to
meet the quality standards of drugs (Vis, Lavalaye and van de Garde, 2015). While on the other
hand, Regression will lead to the effective changes to keep the standards and measures intact to
firm.

8. Explain:
 Case control study: It is the test which is used to get the observational study in which
two existing group differs. The outputs are been identified and is analysed on the basis of
casual attributes.
 Cohort Study: In this one of more sample are been followed with respect to various
disease to identify the better outcome of the initial research on participants that are been
conducted.
 Cross section study: It is done to analyse a larger population involving the common as
well as the differentiating traits which will improve the efficiency of the drugs and get the
appropriate result or the output that helps in the significant rise in the operational quality
of the company to meet the needs and demands of the people (Lawrence And et.al.,
2014).
 Ecological study: This study will help in the identification of the various measures that
will lay a significant impact on the ecological factors of the pharmaceutical firm. This
will help to produce the goods and services in an effective and significant manner.
9) What is meta analysis and how it is performed.
The meta analysis is the effective measure to perform the multiple researches and then
combine their results to effectively analyse that will help in the better understanding of the needs
and demands of the organisation. It improves the size of estimates and their effect to resolve the
uncertainty when a report disagrees. It involves the combining of common facts and figures in all
the research processes to get better and accurate output. It will help the pharmaceutical firm to
identify the most appropriate measure to develop and manufacture the proper drugs and
medicines.
10. SAS sorfware and its advantage over other.
The SAS software will help in the better handling of the analysis process that will help in
better management of the different operations in a very significant manner. This will help the
pharmaceutical firm to develop a better product or service that will help in the effective rise in
the productivity and profitability by managing the production of drugs and medicines (Elseberg,
Salzig and Czermak, 2014).

It is quite beneficial to use SAS software than the other as it helps in the effective
compilation ad better management of the various operations that will help in significant rise in
gaining a better operational efficiency by the firm. Also, it helps in the better prediction of
various measures that are been taken by the firm to improve stability.
11. How to create scatter plot using minitab.
Step 1: select graph> Scatter plot.
Step 2: Select the graph type.
Step 3: Specify the x and y axis variables.
Step 4: Click on OK button. The Scatter plot will appear.
12. Enlist and explain various plots used in statistics.
The different types of plots and graphs are been used in the statistics are as follows:
 Bar graphs: this will involve the interpretation of the various data on the graph in the
form of rectangular bars to show the position on axis.
 Box plot: The data is represented in the form of box or whiskers on the axis's of the
graph.
 Time plot: This is used to show case the time framers and milestones covered.
 Pie Graph: It is used to interpret and depict the data in the form of circular pie. It
basically showcases the percentile composition (Lawrence and Woodcock 2015).
13. Difference between parametric and non para metric test and the type of data obtained from it.
Parametric Test Non Para metric test
It is based on the given and set parameter. It is based on the non metric, independent
variables.
It is based on distribution. It is done for the arbitrary.
It is measured in interval or ratio. It is nominal or ordinal.
It is applicable on variables It is applicable on both variables and attributes.

The Parametric test helps in the effective collection of parameters and statical data while
the non parametric test will help in the developing of the various hypothesis that are been taken
into effective consideration.
14. Enlist software's used for T test and T test in excel.
Various software's such as MS Office Excel, NCSS etc are been used for the effective
analysis of different data's and parameters that are been collected to perform T Test (Atkinson
and et.al., 2016). The steps to use MS Excel for the T test are:
1. Perform an F test to get the essential data for the test.
2. Go on Data tab and click Data analysis.
3. Select t Test and its Type and click OK.
4. Click on Variable 1 and 2 and select the range.
5. Click on Hypothesized Mean difference box and type 0.
6. Click the output range and select the cell to showcase data. Click OK.
15. Difference between F test and Z test.
F test Z test
It is used to compare the sample size of
variability.
It is used to find the mean of a population
against a standard.
F test helps in the comparing of 2 population
variance.
It is used to test a characteristic against a
standard proposition.
It helps in the analysis of degree of variance. This test analyse the deviation.
The variables are unknown. The data or population is known.
Section C
1. Different non parametric test used in statistics
Some major non parametric test that are been used in statistics are:
 1-sample sign test: This test is used to estimate the median of a population and compare
it to a reference value or target value.

 1- sample Wilcoxon signed rank test: It helps in the comparison of population median
with reference or target value.
 Friedman test: It is used tom test the differences between various groups with ordinal
dependent variable in one way ANOVA.
2. Explain RCT
Randomised control trial or RCT will help in the effective handling of the different
operations which will help in the rise the scientific approach of the research process and reduces
the bias when a new treatment is been tested. It involves the effective use of placebo effect to
have a better understanding of the different measures that will help in the significant rise in the
productivity and profitability (Shih and Wang, 2016). The data collected is random and is needed
to be analysed well.
3. Explain Graph pad prism software
The Graph Pad Prism is a 2D software that enables the users to draw scientific and
statical graph and is used in biostatistics. It supports in both Windows and Mac OS. This soft
enables the user to get statical guidance, analyse the checklist, perform the non-linear regression.
It also provides the chance to give live links to the user. Various data or information that is been
added in the table, Prism automatically update the graph and result. Also, it showcases the error
bars to manage the raw data.
4. What is measurement of central tendencies and dispersion. Explain interval estimation.
Measurement of central tendencies is the process calculating the average set of data. The
average represents the centre of distribution. The data gained is descriptive in nature, which
indicates that they summarise the data. It helps in the better handling of the mean mode and
median that is been obtained from the data. The measurement of dispersion is the process to
make out the mean to summarise the centre of the distribution. It showcases that how far the
obtained data differ from average.
The interval estimation is the process to use the sample data to calculate an interval of
possible values and the values of unknown parameters. It contrasts the appropriate point
estimation process. It gives the range of value which is likely to contain the population parameter
(Guideline, 2015.).

5. Different types and advantage and disadvantage of Adaptive design and quasi experimental
design.
The adaptive design ids the meta modelling technique that will help in the addressing of
the entire issue of the prediction of the various operations in a better way. It is the system
response constructed from the value of selected inputs. It is the initiation of trial after
undermining its validity and integrity. Its major advantage is that it makes the clinical trials more
flexible, efficient and fast. But the main disadvantage is that it involves the random data size.
The quasi experimental design is the empirical study that help in the better analysis of the
casual impact of intervention on the target population without random assignment. The major
advantage is that it helps the researcher to control the assignment of the treatment condition. It
helps in the better management of randomisation. Although, the major disadvantage is that it the
data can get altered by the data or confounding variables (Newton And et.al., 2015).

PART 3
Ques 1. Efficacy Guidelines no. E-2C (R2) and E 2A
E2 A, guideline was formulated in 1994. It provides the standards as well as terminology
for the important aspects of clinical safety reporting. E-2 A also provides guidance related to the
procedure of handling rapid reporting of medicines reactions during the investigation al creation
of medicines.
E-2C stands for Periodic risk evaluation report. This efficacy guideline was introduced in
1996. It delivers a guidance related to the format as well as content of safety updates, which is
essentially required to be rendered at regular intervals to regulatory authorities after products
have been marketed. Objectives behind creation of this guideline are to ensure that the global
safety experience is provided to authorities at definite times after marketing with maximal
efficiency and avoiding duplication of effort (Haleem And et.al., 2015). (R2) indicates revised
which purpose is to confirm that periodic safety update reports for marketed drugs have the role
of being periodical benefit-risk evaluation reports by screening several aspects such as evaluation
of safety, analysis of all information etc.
Ques 2 Responsibilities of Investigator during clinical trials
During the execution of clinical trial, duty as well as responsibility of investigator is to
prepare, organise as well as administration of a research grant, forming of cooperative
agreement, training to workers, monitoring public service project in conformity with applicable
laws as well as regulations. It is duty as well as liability of investigators to execute clinical
research. Clinical Investigators are accountable for ensuring that an investigation is conducted as
per the investigator statement. Responsibility of the investigator is to give proper direction for
execution of the research in systematic manner. It is the duty as well as accountability of
investigators to support workers in overcoming the barriers or dealing with challenges that can
occur in conducting research (Alli, 2016.). They are responsible for meeting research
expectations. A clinical investigator is mainly responsible for executing investigation which
contributes to generic or specific knowledge when protecting the rights as well as welfare of
workers.

Ques 3. GCP
The term GCP indicates Good Clinical Practice. It is recognised as quality standards
which are applicable to all types of clinical practices worldwide. These standards are developed
by the authority at global level which governments can then turn into regulations for clinical
trials involving human subjects. Some principles of ICH GCP are:
 It states that all clinical trials are required to be executed as per the ethical principles
which are consistent with good clinical practices and the applicable regulatory
requirement.
 Other principles of ICH GCP interpretative that investigator is required to conduct risk
assessment procedure before implementing or introducing new clinical practices.
 It is required by investigator to consider following factors such as safety, right, and well-
being of the trial subjects (Nally, 2016).
 The investigator should use detailed protocol for conducting scientifically sound clinical
trials.
 A trial should be executed in compliance with the protocol that has received prior
institutional review board or independent ethics committee favourable suggestion or
permission.
Ques 4 Roles and responsibilities of IRB
IRB stands for International Review Board which is recognised as the committee which
is created to defend the rights as well as to ensure welfare of employee involved in clinical
investigation activities as prescribed by government regulations.
International Review Board has the power to give permission related to amendments in
the research or study. This legal authority plays crucial role in the protection of the rights and
welfare of human research subjects. IRB is responsible for monitoring the investigation and
driving team towards accomplishment of desired objectives. It is the duty of International
Review Board to meet the membership and operational requirements of federal regulations
(Allison and et.al., 2015). The objectives as well as role of international review board are to
ensure that the rights as well as welfare of research subjects are protected. It is the duty of IRB to

provide written notification of decision related to approval of the research. Duty of IRB is to
determine that elements are contented prior to approval of research activities.
Ques 5 Several certificates which are to be issued under WHO on quality of Pharamaceutical
products
Certificate of pharmaceutical product, this is issued by WHO for only one product,
because manufacturing arrangements as well as approved information for different
pharmaceutical forms and strengths can vary. This type of certificate is required to be obtain by
Pharmaceutical companies importing product from different countries (Parikh, 2016). Certificate
of pharmaceutical product has been introduced by world health organisation to ensure the quality
of medicines which has been imported from the other countries.
Good manufacturing certificate is required to be obtained by the firms engaged in
production of drugs or medicines. This certificated is issued by world health organisation to
companies whose manufacturing site is periodically inspected by certifying authority as well as
firm conduct ethical manufacturing practice.
Ques 6 GCLP
The term GCLP stands for Good clinical Laboratory practices. It highlights the principles
as well as process that are required to be followed by medical laboratories those who are engaged
in clinical research or offering care to patients. Such clinical institution should provide quality
data or information which can be utilized for conducting health research and patient treatment.
Collection of quality information is an effective strategy which can be used by the clinics for
minimising the cost and for becoming ethically sound (Lee, and et.al., 2015.). It is required by
clinical institution to follow these guidelines as this will help organisation in improving the
quality of services and enhancing the research activities. GLP certification is associated to the
test facilities involved in conducting safety studies on chemicals. It provides the guidelines
which are required to be complied by clinical institution as this will assist organisation in
ensuring the quality of test results.

Ques 7 CAPA
The term CAPA stands for Corrective and preventive action plan .This is very much
essential to be implemented as it helps in resolving the several problems related to clinical
practices or environment. Corrective and preventive action plan is associated with the concepts
or approach related to the quality of pharma products during the manufacturing process.
Organisation which is governed or controlled by the US Food and Drug Administration are
required following ISO which is quality standard and needed to maintain Corrective and
preventive action plan as the important element of quality management system
(Govindaraghavan and Sucher, 2015.). It is considered to be as an effective tool which can be
used by clinical institutions for dealing with Quality issues. CAPA includes the various activities
such as investigating the root cause of problem , recognising as well as implementing appropriate
solution.
Ques 8. Meaning of Following Term:
A) FMEA :The term FMEA stands for failure mode effects analysis. It is recognised as
systematic approach which is adopted by clinical institutions for identifying possible defects or
errors in research design, manufacturing procedure as well products or services. This type of
analysis includes revaluation of several components, subsystems or variables as possible to
determine the failure modes, root causes and its impact on clinical practices or research.
B) FMECA: Its full form is Failure mode, effect and critical analysis. FMECA is recognised as
inductive analytical method which can be used by clinical institution in investigation vat specific
level. It is the tool adopted for identify potential failure mode and for accessing the risk related to
those failures (Vives, Oliver-Vila and Pla, 2015.).
C)FTA: It stands for free trade agreement. FTA are associated with trade in products as well as
services, market investment , protection of intellectual property as well as public procurement.
As per this agreement , pharmaceutical companies require producing the data through expensive
global clinical trials to prove the efficacy as well as safety of new medicine introduced by them.
D) HACCP :Its full form is Hazard analysis and Critical control points. HACCP is
recognised as systematized preventative concept related to food safety from biological,
chemical as well as physical risk or danger in production procedure. As it might lead

finished product to be unsafe, and designs measurements to minimise these risks to a
harmless level.
Ques 9 Deviation Handling under Quality management system.
Deviation is defined as difference between the actual and standard performance or
outcome. This deviation might take placing during the time of sampling or testing activity,
manufacturing process etc. Quality management system plays significant role in assuring quality
in products or services by contributing to continuous improvement. Deviation handling and
quality management system are the two main process which supports in discriminating events on
the basis of relevancy as well to categorise them (Allison and et.al., 2017). Resources and efforts
in quality management aids clinical institution in identifying the root cause of deviation.
Effective quality management system enables clinical institution to reduce this deviation and
support in generate of desired outcome. Quality Risk Management is always been significant part
of the analysis procedure associated with the handling of events and deviation in clinical
operations. It renders the guidance as well as strategy which can be utilised for differentiating
non significant events with crucial factors which have great as well as direct effect on the
quality of pharmaceutical products or services.
Ques 10 Guidelines no. S1 A and S3 A for safety
The guideline related to S1 A is based on the analysing the requirement for
Carcinogenicity studies of pharmaceuticals. This guideline was introduced in year 1995. S1 A
provides guidance related to the condition under which it is essential to conduct carcinogenicity
studies on new drugs or medicines. During this procedure several factors such as risk, duration of
exposure and other indicative variables are considered (Felix, 2018).
S3 A, this is the guidelines related to the assessment of systematic exposure in toxicity
studies is being provided. It provides the guidelines or road map for formulating the trial
strategies related to toxicity which are required to be combined pharmacodynamics with toxicity
testing. As this will aid clinical institution in interpretation of the toxicology findings as well as
will support in promoting rational study and development of design.

Ques.11 Guideline E3 related to structure as well as content of clinical study report
The purpose of Guideline E3 is to enable a compilation of a single core clinical study
report accept all regulative regime of the ICH area. This guideline was first introduced in
1995.objective of this guideline is to provide or define the specific format as well as content of
the study report. Guideline E3 comprises important report which is suitable for all submissions
and appendices that are required to be available but will not be submitted in all scenario.
The clinical study included in this guideline is defined as an integrated complete report of
any single report of any therapeutic, prophylactic or diagnostic agent executed on patients.
Clinical report includes statistical description, analyses and presentations which are incorporated
into a report, integrated tables as well as figures into the primary text of the report or at the end
of the text and with appendices comprise the code of conduct, sample case report etc (Cusato, S.
and et.al., 2014).
Ques 12. Meaning of CTD
CTD is recognised as a short document which provides a critical assessment on clinical data or
information. On the other hand clinical summary consists of big as well as important document
which emphasizes on summarisation as well as integration of clinical information. CTD is also
recognised as Common technical document which is categorised into following part such as
biopharmaceuticals, product development rationale, safety , efficacy, conclusions related risk as
well as safety. It provides appropriate format for technical documentation which help in
minimising time and reducing the need of resources which are required for integrating
application for registration of human pharmaceuticals. CTD provides ease in submission of
information related to clinical practices. It is very essential for clinical institutions to ensure that
information or content provided by them in transparent as unambiguous. CTD is categorised into
several modules such as Administrative information as well as pre-scribing information , quality
documentation, non- clinical reports , clinical trials etc.
Ques 13 Roles as well as responsibilities of sponsors in clinical trials
The role or function of sponsors to monitor the clinical trial. Sponsors are the person
those who are accountable for conducting , managing or providing financial resources which are
required for executing clinical trial. It is the duty of sponsors to ensure that all the applicable

norms , regulation as well as standards are being followed during the clinical practices. The other
functions of sponsors are to provide direction as well as complete information about the way
clinical practices are to be executed (Doe, 2017.). They are also accountable for monitoring the
clinical trial.It is the duty of sponsors to ensure that all essential ethical review as well as
permission are obtained before conducting ant research or clinical practice. Function of sponsors
is to confirm that regulatory authorities as well as ethics board are informed about new
information about the findings. They are also responsible for assuring that clinical institution are
complying with labelling, reporting as well as record-keeping regulations and executing clinical
study as per the guidelines of the good clinical practice.
Ques 14 Documents that are to be prepared before the execution of clinical study
The important documents which are required to be created before conducting the clinical
trial are :
Investigators Brochures:The objective of this document to record the relevant as well as latest
scientific information about the product on which research is to be conducted.
Signed protocols as well as amendments; to kept as evidence related to agreement between the
sponsor and investigator.
Informed consent form:To record the informed consent.
Advertisement for recruitment: It is the evidence which demonstrate that recruitment measures
are appropriate and not coercive.
Financial aspect of trial; It is the record of financial agreement between sponsors as well as
investigators (Fries, 2016).
Insurance statement; the objective of keeping this document is to document that compensation to
subject for trial-related injury will be available to person involved in clinical study.
Pre trial Monitoring report: this document is prepared in order to demonstrate that location or
area is suitable for conducting the clinical trial.
Master Randomisation list-It consists of the details about the sample population on which thebv
clinical investigation's will be done.
Decoding process for blinded trials- It is prepared by considering the risk factor. This document
is created in planning the way which will be used ion case of emergency situation.

Sample label attached to investigation product container – This document is prepared in order to
provide instructions that is essential for storage, packaging, dispensing and disposition of
investigation al goods.
All these legal documents serve to show the conformity of the investigator, sponsor and
monitor with the standards of Good Clinical Practice and with all applicable regulative
requirements. This activity also assist clinical institutions in successful management of clinical
trial by sponsors , monitor as well as investigators.
Ques 15. Guideline no. ICHQ 10
The guideline related to ICH Q 10 is related to the good manufacturing practice.
Objective of these guidelines is to accomplish product realisation , bring continues improvement
in quality of pharmaceutical products or services , establish and maintain control on production
activities. This guideline is applicable to product life cycle which includes pharmaceutical
development, technology transfer, commercial manufacturing and product discontinuations. It
can also apply to the system which support the development as well as manufacturing or
production of pharmaceuticals drugs substance. Guideline related to ICH Q 10 is based on
Internalisation quality standards which involves Good Manufacturing Practice regulations. It can
be implemented at the several phases of product life cycle (Luthringer And et.al., 2015.). This
guideline represents that regulatory authorities support of an effective pharmaceutical quality
system to improve the quality and availability of medicines. When the ICH Q 10 is applied to
the various stages of life cycle helps in development of innovative products as well as bringing
improvement in existing goods. The ICH q 10 should be applied in appropriate as well as
systematic manner to each stage of product life cycle. The objective of this specific guideline is
to complement or improve regional GMP requirements.
SECTION C
Ques 1 Quality management system
A quality management system is considered to be as formalized or official as well as
effective system which record the procedures. This system defines the roles as well as
responsibility of an individual in maintaining or bringing the improvement in the quality of
product or services. Quality management system assist in coordination. It also provides business

entity a direction related to catering the needs as well as in fulfilling the legal requirement (Aung
and Chang, 2014). The quality management system also support organisation in delivering
higher level of satisfaction to customers. It assists firm in increasing the effectiveness as well as
improving working efficiency
Quality management system support an organisation in accomplishing several objectives such as
enhancing procedures , minimising wastage as well as cost, engaging employee in the activities
etc. It is considered to be as effective system in terms of controlling the procedures as well as
products. Quality management system also enables firm to gain customer loyalty. It also
provides business entity an opportunity to attract more number of customers and retain
relationship with existing client by delivering them the quality products or services. Quality
management system support organisation in maintaining the quality of goods or services (Clegg
and Perry, 2017).
A quality management system is defined as the collection of several business procedures
which emphasizes on catering the requirement of customer and fulfilling their demand. Tradition
concept of quality management were much concerned about predictable outcomes of an
industrial product. But now modern techniques of quality management is more concerned about
the sustainability issues. It is based on assumptions that the problems related to quality will be
minimised as an outcome of systematic thinking, transparency, documentation and diagnostic
discipline. Quality management system is very much helpful as well as beneficial as it helps in
identifying product defects or error in the procedures. It also supports manager in making the
plans to eliminate errors and helps in ensuring product safety. In context of clinical trial, quality
management system supports in addressing the defects in design in medical devices (Webster,
Castellano, J.M. and Onuma, 2017).
Quality management system involves several requirements related to safety of patient as
well as management of clinical risks. The benefit of quality management system includes patient
safety , elimination of clinical risks. It also helps management team as well as investigator in
ensuring data integrity. Reducing the delay in clinical trials .The several benefits which are
gained by sponsors through effective quality management is improved image in the market and
increase in creditability of medical research. The several elements of quality management system

are data management system , internal procedure, Customer satisfaction from product quality
analysis and Improvement opportunities. The procedure of quality management system includes
various phases such as designing , this phase include developing the structure or framework for
quality management system. It is required by senior management team to review the process in
order to ensure that need of business as well as demand are fulfilled.
The next phase is deployment, in which each task is break down into small activities. In
this stage employees are defined about their roles as well as responsibilities and they are
provided with appropriate training. Intranet is the tool which is adopted for deploying the quality
management system.
The next phase is control and measure, this is the important activity to ensure that the
quality of pharmaceuticals products and services. Controlling as well as monitoring of quality
management system can be done through systematic audit.
Reviewing and making improvement: This is the last phase which support management
system in identifying the errors as well as recognising area of improvement. It also supports
management system in ensuring effective outcome. Reviewing also supports management team
in judging or analysing the effectiveness and efficiency of each procedure.
Ques. 2 Clinical Trial protocol
Clinical trial is defined as investigations procedure in which volunteers are appointed for
testing new treatment. These trials are conducted in order to detect , prevent errors as well as for
managing several diseases and medical conditions. Protocol in medical science refers to as the
written process which include designing as well as presentation of experiments (Cole And et.al.,
2017). These protocols assist management team in ensure successful replication of results by
others in the same laboratory .In other words , protocol can also be defined as important
documents which highlights the way clinical trial will be executed , its objectives , statistical
considerations involved etc. It helps management team ion ensuring the safety of participants as
well as volunteer during the clinical trial. This protocol also aid management team in
maintaining the integrity of data or information collected during the investigation or trial.
Research protocol also defined the background, purpose of the trials. NIH is the authority which

is responsible for providing resources for development of protocol. These resources further help
investigators in writing as well as processing clinical research protocols that are in conformity
with regulatory requirement of good clinical practices. In addition to this clinical protocol also
includes details about the processes in detail, information related requirement of some
equipment, safety precautions, analysis as well as interpretation of outcomes, rules for specify
and documenting eliminated in data to avoid biasses (Altenstetter, 2017.). These protocols are
used in various types of investigation or clinical experiments such as from social science to
evaluation of machinist activities. Written protocols are applied in manufacturing for improving
as well as maintaining the quality of pharmaceuticals products or services. Clinical protocols are
designed specifically for governing general clinical practices required to be conducted by the
laboratories. Manufacturing protocols are needed for increasing good manufacturing practices
for production of foods, pharmaceuticals and medical devices.
3. How the quality can be assured in clinical research.
The quality plays a very crucial and significant role in the operations which will help in
the significant rise in the productivity and gain a better handling of the different operations in a
clinical trial to maintain the quality. The ICH has set up certain guidelines which help in better
sustaining of the quality (Mendelson and et.al., 2016). Some are as follows:
 Clinical trial must be conducted in accordance of ethical principles.
 Before the initialisation of a task, the risks and inconveniences must be anticipated in
order to reducing of risk factor.
 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
 All the information of clinical trials are needed to be well stored for the further analysis
and reviewing purpose in a better way.
4. Seven steps of CAPA in pharmaceutical industry.
The Seven steps of CAPA in pharmaceutical industry are as follows:
 Identification: It involves the identification of the actual problem and describing it in its
current condition.
 Evaluation: The problem described and recorded in the previous step is now evaluated
and analysed to gain a better share of the possible risks in an organisation.

 Investigation: It involves the assessment of the problem and it is ensured that all the
concerning factors of the trial are been well evaluated.
 Analysis: In involves the detailed assessment of the various risks and factors that are
been identified in the previous step to find the cause of the problem. The contributing
causes are been assessed and various process and procedures, that are the root cause of
problem are been taken in effective consideration (Todd And et.al., 2014).
 Action plan: Once the problem are been identified, an action plan is been made to
prevent them along with the proper recording of the various measures of problem solving.
 Action implementation: the action plan that is been made, is effectively identified. All
the required tasks are been taken in effective consideration.
 Follow up: It will involve the various measures to perform multiple functions and
compilation of various changes and measures are been record and stord for future
utilisation.
5. Explain ICH Tripartite Guideline ODF Quality risk management (Q9)
The ICH Q9 Guideline will involve the various measures to control the effective quality
risk management which helped in the better assessment of the various operations in a very
effective way to get proper productivity and profitability at the pharmaceutical firm that will help
in better handling of various measures to maintain the quality standards at the work place and of
different drugs and medications (Russell, 2017). The better risk assessment helps in effective
handling of different operations to maintain the quality standard.
CONCLUSION
It can be concluded from the report the quality is the heart and soul and most important
for an organisation. This report covers the details of the various quality measures that are been
taken into effective consideration by the pharmaceutical firm to sustain their customer
satisfaction level. The various tests that are been discussed will help the firm to get an effective
and good idea about taking various measures to maintain the quality of the drugs and medication
they produce and manufacture. The various measure that are been taken into consideration to
prevent the contamination of drugs ore medicines from the microorganism's will help in
maintaining the quality of drugs. Also, various quality test like pyrogen test, microbiological

limit test will support the better protection of drugs and medications. The biostatistics is also
discussed helping in taking effective measurements and management at pharmaceutical firm. The
guidelines which are been discussed will help in effective following of rules and regulations that
will help in better handling of different operations and maintain the qualitative standards at
pharmaceutical firm.

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