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Quality Assurance Assignment

   

Added on  2020-06-04

41 Pages14882 Words85 Views
Quality Assurance & GoodManufacturing Practices
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Table of ContentsINTRODUCTION...........................................................................................................................1PART 1............................................................................................................................................1Section A.....................................................................................................................................1Section B.....................................................................................................................................11. Tests for the effectiveness of the antimicrobial preservatives................................................12. Different phases of teratogenic activity testing.......................................................................23. Difference between accuracy and precision............................................................................24. What are the different types of glass used in pharmaceutical manufacturing and discusstheir chemical resistance test.......................................................................................................35. Bracketing design for testing the new drug substance............................................................46.short note on following tests:...................................................................................................47. Describe the storage condition and testing frequency for long term and accelerated stabilitystudy of the drug substance.........................................................................................................58. Why is the testing of Bacteriostasis and fungi stasis carried out before sterility testing.Describe the inoculation method.................................................................................................69. Explain the ICH guideline for stability testing for new drugs................................................610. Describe the microbiological limit test for the Pseudomonas aeruginosa............................711. Explain quality control test for Metal containers, paper, paper boards and cardboards aspackaging material......................................................................................................................712. What is acute toxicity and what is the need of acute toxicity testing....................................813. Describe the pyrogen test for quality control testing of parenteral products........................914. Explain WHO guidelines for ongoing stability study for active pharmaceutical ingredients.What is significant change..........................................................................................................915. Describe the physical test for the quality control testing of ointments...............................10Section C...................................................................................................................................101. Describe the Bioanalytical method validation and the parameters involved........................102. Detail Note on ICH guidelines for photo stability study for new drugs and substanceproduct. .....................................................................................................................................113. OECD guidelines for chronic toxicity...................................................................................11
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4.) List various packaging material of pharmaceutical industry and quality test for plastics...125. What is mutagenicity and its various tests............................................................................12PART 2..........................................................................................................................................12Quality Testing Tools and Techniques..........................................................................................12Section A........................................................................................................................................121. P values> 0.05:......................................................................................................................122. ANOVA is an example of:....................................................................................................123. Test used in ANOVA............................................................................................................134. D) Non Bliend trial................................................................................................................135. A) RCT..................................................................................................................................13Section B........................................................................................................................................131. Meaning of biostatistics and various related terms...............................................................132. Point estimation.....................................................................................................................133. Difference between statistical significance and P-values.....................................................144. T-test and differences between paired and unpaired test......................................................145. Hypothesis testing.................................................................................................................156. Differences between Pearson's Correlation Coefficient and Spearman's CorrelationCoefficient.................................................................................................................................157. Analysis of means and comparison of correlation with regression.......................................168. Explain:.................................................................................................................................169) What is meta analysis and how it is performed....................................................................1710. SAS sorfware and its advantage over other........................................................................1711. How to create scatter plot using minitab.............................................................................1712. Enlist and explain various plots used in statistics...............................................................1813. Difference between parametric and non para metric test and the type of data obtained fromit.................................................................................................................................................1814. Enlist software's used for T test and T test in excel............................................................1815. Difference between F test and Z test...................................................................................19Section C...................................................................................................................................191. Different non parametric test used in statistics.....................................................................192. Explain RCT..........................................................................................................................19
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3. Explain Graph pad prism software........................................................................................194. What is measurement of central tendencies and dispersion. Explain interval estimation.....205. Different types and advantage and disadvantage of Adaptive design and quasi experimentaldesign........................................................................................................................................20PART 3..........................................................................................................................................21Ques 1. Efficacy Guidelines no. E-2C (R2) and E 2A .............................................................21Ques 2 Responsibilities of Investigator during clinical trials...................................................21Ques 3. GCP..............................................................................................................................22Ques 4 Roles and responsibilities of IRB.................................................................................22Ques 5 Several certificates which are to be issued under WHO on quality of Pharamaceuticalproducts.....................................................................................................................................23Ques 6 GCLP............................................................................................................................23Ques 7 CAPA............................................................................................................................23Ques 8. Meaning of Following Term:.......................................................................................24Ques 9 Deviation Handling under Quality management system..............................................24Ques 10 Guidelines no. S1 A and S3 A for safety....................................................................25Ques.11 Guideline E3 related to structure as well as content of clinical study report.............25Ques 12. Meaning of CTD.......................................................................................................26Ques 13 Roles as well as responsibilities of sponsors in clinical trials....................................26Ques 14 Documents that are to be prepared before the execution of clinical study ................27Ques 15. Guideline no. ICHQ 10..............................................................................................27SECTION C...................................................................................................................................28Ques 1 Quality management system.........................................................................................28Ques. 2 Clinical Trial protocol .................................................................................................303. How the quality can be assured in clinical research.............................................................314. Seven steps of CAPA in pharmaceutical industry................................................................315. Explain ICH Tripartite Guideline ODF Quality risk management (Q9)...............................32CONCLUSION..............................................................................................................................32REFERENCES..............................................................................................................................33
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INTRODUCTIONThe better quality management and manufacturing practices is very necessary that helpsin the better productivity and profitability. The better quality will help a business organisation ingaining an effective customer satisfaction level. This report will cover the better microbial partand its effectiveness, the difference between precision and accuracy and different pharmaceuticalpackaging material is been taken into consideration (Newton And et.al., 2015. ). Various stabilitytesting are been taken into consideration and ICH guidelines are been taken in effectiveconsideration. Apart from this, the acute toxicity and its various tests are been discussed. TheWHO guidelines are been discussed. Other than this the various bio analytical measures are beentaken into effective consideration with OECD guidelines are been discussed.PART 1Section A2.C) Pseudomonas aeruginosa3.D) Photo stability testing of the new drugs or substance.4.D) 14 Days5.C) Weight Variation test.6.C) 8.5 mlSection B1. Tests for the effectiveness of the antimicrobial preservatives.The antimicrobial preservatives are very necessary and vital in the pharmaceuticalindustry as it helps in the safeguarding the life saving drugs from getting contaminated. This willhelp in producing and manufacturing the high quality drugs and medicines to customers. Theantimicrobial preservatives will protect the medicines and various types of drugs from the gettingaffected by the microorganisms and keep the medicine sterile and viable in variousenvironmental condition (Haleem And et.al., 2015). The major function of the antimicrobialpreservative is to prevent the growth of the bacteria and other contaminations in the vital drugsand medicines. This will help the customers to get the safe and high quality drugs andmedications in a very effective way.
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Such preservatives are added in almost every sort of the drugs and medicines includingthe parenteral otic, nasal, ophthalmologic, oral and topical sort of drugs in solid and aqueousbases. It helps in gaining the better handling of the different operations which helps in theeffective handling of the various operations. It helps in increasing the shelf life of the drugs andmedicines and reduces the constraint of the temperature specific storing of the medications at aclinic or pharmaceutical shop. This it helps in maintain the quality of drugs for prolonged period(Alli, 2016).2. Different phases of teratogenic activity testingThe teratogens are the effective chemical or drugs that lead to the severe toxicity andinhibition in the body. The effective testing of the toxic material is very necessary for thesafeguarding the life of an individual. The presence or the consumption of any sort of teratogeniccomponent 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 tounderstand its consequences on the human body. Whole Embryo culture test: It involves the process of culturing or growing of embryoof an animal like frog or mouse to carry out the teratogenic compounds and itsimplication on user.3. Difference between accuracy and precisionThe accuracy and provision plays a very vital and crucial role in the maintaining anddeveloping of the proper product or service. In the pharmaceutical field, the accuracy andprecision plays a very crucial and vital role in development of the high quality product andservices (Nally, 2016.). The major difference between accuracy and precision is as follows: AccuracyPrecisionAccuracy indicates the difference between themeasurements set and the actual valueachieved.Precision is the variation that is visible whenthe value is measured from the same device,again and again. It indicates the closeness of the value achievedfrom the value that is been set in the target.It indicates the measure that how closely theresults agree with each other. It is dependent on the degree of confirmationThis is dependent of the degree of the
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of achievement of exact result.reproducibility in an organisation.It is dependent on single factor of theexecution.This is affected by the various factors that canimpact the precision to get the desiredproductivity.Its measurement is statically biased and isbased on the target that is been set.This may contain the statically variabilityevery time it is been measured (Allison andet.al., 2015).It gets impacted by the systematic errorsoccurring during measurement.Precision is deeply effected by the randomerror caused during the measurement of theoutput or result.4. What are the different types of glass used in pharmaceutical manufacturing and discuss theirchemical resistance test.The pharmaceutical industry uses a wide variety of apparatus to manufacture and test thevarious medication's. They use various quality and composition of glass that is used for thevarious medical operations and manufacturing purposes. Some major glasses used inpharmaceutical industry to get better quality are: Parenteral UseType I Glass: Highly resistant borosilicate glass: It is used for high number of buffered and non bufferedaqueous 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 andchemical 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 havingthe tangibility of dry powder form or as oily solution (Parikh, 2016). NonParenteral UseType IV Glass:
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General purpose Sodalime Glass: It is used for the non parenteral purposes and utilised for thetablets, oral medications and other external drugs.Various evaluation parameters are been taken into the effective consideration for thebetter testing of the Glass components that are been used in the pharmaceutical industry. Somemajor tests that are been followed are:Crushed glass test: The container is well crushed and the sieved to get the uniformparticles. A definite quantity of mixture is taken and is treated with the various solutionsto test is reactivity with the various solutions. This helps to determine that the glass istreated or not.Whole container test: In this, the complete apparatus is been tested for its tensilestrngth, reactivity and smoothness in order to use it effectively for the variouspharmaceutical 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 drugsor the medication that is been used by the pharmaceutical organisation for the testing thereactiveness and stability of the drugs in various chemical composition. It helps in getting theappropriate output and reducing the wastage of the medication that is been produced andmanufactured. It reduces the number of sample size required to get the appropriate output. Ithelps in getting the effective data about the estimated shelf life of a drug. It helps in the bettertesting of the batches of the smaller quantity of different drugs and medicines. The stabilityowning 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 thesample required for testing and thus saves the production and management cost as the productionand storage cost of the various drugs and medicines are quite high and expensive. The bracketingwill help in the better handling of the production design, setting up of goals and improve theproduct quality. It involves the following of the various factors such as strength and packagesize. And get the better stability of the various drugs on the intermediate level (Vives, Oliver-Vila and Pla, 2015).
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