University Quality Assurance and Control Assignment - Module 7-9

This document presents a comprehensive solution to a Quality Assurance and Control assignment, encompassing modules 7-9. It delves into various aspects of quality management, including total quality management (TQM), its objectives, and benefits. The solution explores the steps of PDCA, hazard ...Read More

Quality Assurance and
quality control

Table of Contents
Table of Contents
Module 7..........................................................................................................................................3
1 New philosophy companies.................................................................................................3
2 Quality assurance depends on two focal points...................................................................3
3 The Japanese integrated quality throughout their organization and developed culture of. .3
4 Not included in the form of improvement encouraged under total quality ?......................3
5 The specific concern of total quality management..............................................................3
1 Total quality management...................................................................................................3
2 Objective of total quality management................................................................................3
3 Benefits of quality system.................................................................................................4
4 Steps of PDCA....................................................................................................................4
5 Hazard analysis and critical control points.....................................................................4
6 ICH objectives....................................................................................................................5
7 FMEA and its area of use ?..............................................................................................5
8 Quality risk management for facilities and equipments......................................................5
9 Explanation about the corrective action and prevention action..........................................5
10 The activities that should be conducted to mange and continuously improve the
pharmaceutical quality system...............................................................................................6
11 The objective of FDA guidance on quality system approach to pharmaceutical GMP
regulation................................................................................................................................6
12 Quality system models......................................................................................................6
13 How are nonconformities and deviation handled in any quality system...........................6
14 Explain the ISO standard related to risk management......................................................7
15 Describe in brief REMS....................................................................................................7
1 Quality management detail..................................................................................................8
2 Primary elements of Total quality management..................................................................8
3 General quality risk management process as per ICH guidelines.......................................9
4 GMPs and the concepts of modern quality systems............................................................9
5 Management responsibilities in quality system models......................................................9

Module 8........................................................................................................................................10
1 Ideal frequency of conducting...........................................................................................10
2 Tablets and capsules are susceptible to airborne contamination due to the......................10
3 A sterile drug product is....................................................................................................10
4 When the organoleptic examination does not conclusive evidence the inspector shall have
sample tested using which method ?....................................................................................10
5 L.A.L stands for:................................................................................................................10
1 Define inspection and its objectives..................................................................................10
2 Objective of performing re inspection...............................................................................10
3 Describe the roles and responsibility of the inspector.......................................................11
4 What is the site master file ?..............................................................................................11
5 Four classification of drugs and significance of national drug law...................................11
6 Essential for pharmaceutical inspectorates to establish and maintain liaison with OMCL11
7 Method of sterilization process?........................................................................................12
8 What specific information should be evaluated for the cGMP compliance of intement,
liquids and lotions as per US GMP regulations....................................................................12
9 What are role does supervisory authority in Europe.........................................................13
10 Objective of site inspection as per UK MHRA...............................................................13
11 Critical deficiency and major deficiency under UK MHRA...........................................14
12 I.A.G................................................................................................................................14
13 Language of the quality system audit reports according to health Canada ?..................15
14 Role of the GMP inspectorates per Medicines control council of South Africa.............15
15 The principles of self-inspection as per medicines control council of south Africa.......15
a) Types of audits.................................................................................................................15
b) The qualification of the drug inspectors...........................................................................16
c) Organizational aspect of the drug inspectors...................................................................17
d) Current good manufacturing regulation as per US FDA.................................................17
e) Determination for the laboratory controls in order to conform with appropriate standard18
Module 9........................................................................................................................................18
1 Set of authorize written procedure....................................................................................18
2 Which of the following is not a type of Drug master file as per US FDA.......................19

3 The batch production and laboratory control record should be reviewed and approved by19
4) Which of the Sub part of 21 CFR parts 211 contain record and reports ?.......................19
5) In which level company policies are ordered in Hierarchical document system ?..........19
1 Need of documentation in pharmaceutical industry..........................................................19
2 WHO good distribution practices for pharmaceutical products........................................19
3 The difference between standard operating procedure and protocol?...............................20
4 Describes the control of Document as per ISO 9001-2003...............................................20
5 Describes the record for storage condition and stock control...........................................20
6 Description about Drug master file and site master file....................................................20
7 Record for raw material and intermediates.......................................................................21
8 What is the complaints record and discuss the information to be included in these records21
9 Describes the specification for starting material, intermediate product, packaging material
and finished products as per PICS........................................................................................21
10 Format of SOP and list out the information to be mentioned in SOP.............................21
11 Batch manufacturing record view...................................................................................22
12 Common technical document and describes the different module of CTD....................22
13 Documentation of extemporaneously prepared product..................................................23
14 Describe the record for recall and returned product........................................................23
15 The electronic manufacturing and batch records.............................................................23
1 Laboratory control record and WHO guideline for preparing laboratory information file24
2 Detail note on US FDA guideline on drug master file......................................................24
3 Master production and control records..............................................................................24
4 Complaints file and laboratory records as per records and reports sub parts of 21 CFR. .24
5 Batch production and manufacturing and batch packaging record in detail.....................25

Module 7
Section A
1 New philosophy companies
A Customer driven approach
2 Quality assurance depends on two focal points
C time and motion guideline and management policy on quality
3 The Japanese integrated quality throughout their organization and developed culture of
A continuous improvement
4 Not included in the form of improvement encouraged under total quality ?
A Reducing waste
5 The specific concern of total quality management
A Primarily a worker rather than a management activity
Section B
1 Total quality management
Total quality management is way to deal with make business subjective and successful.
As indicated by this idea, representative's execution can, measures as far as change and quality. It
is otherwise called add up to profitable support, portrays an administration ways to deal with
long haul accomplishment through consumer loyalty (Henry and Adewale. 2013). By utilizing
this idea, all individuals from an association partake in enhancing forms, item, administrations
and the way of life in which they work (Total Quality Management 2016). Toward the end, one
might say that, It is a methodical strategy for the disposal of waste inside a generation framework
in the organization. Organization can receive this technique with a specific end goal to limit the
wastage of creation.
2 Objective of total quality management
Total quality management is the colossal approach which guarantee that nature of items
get kept up. Organization dependably need to give quality items to its shoppers so they feel
fulfilled (Assarlind and Gremyr, 2016). This can be acquired through TQM process on the
grounds that by along these lines refered to firm will have the capacity to improve effectiveness
of tasks and can have the capacity to component wastage from the framework. Add up to is the
immense application that can bolster in distinguishing circle fall in the framework and enhancing
these issues. On other hand changes in laws dependably make issue for the association to roll out

improvements in its tasks. The major objective of the total quality management application is to
improve the quality of the product and services by eliminate wastage and additional cost from
manufacturing and production procedure.
3 Benefits of quality system
 Quality framework techniques serves to change in organization's business, stock esteem
and workers development . It is anything but difficult to gauge in various execution.
 Another preferred standpoint of this strategy is in increment the client esteem, it gives the
consumer loyalty by enhancing the activity fulfilment in workers of the organization.
 Quality framework system enhances the nature of execution in the business (Bo and
et.al., 2015).
 It likewise advances the consumer loyalty by giving them nature of administrations in the
business.
 The real quality of this method to beat the blunder during the time spent administration
 By use of quality system within the production and manufacturing activities, company
can eliminate the additional wastages from the business and improve quality and
efficiency of product and services.
4 Steps of PDCA
The Plan- do- check- Act have major four stages for improve quality and effectiveness of
product and service. This technique is majorly use in the production and manufacturing activity
and process for improve quality of services. Following are stages of this PDCA model-
Plan- In this stage involves assessing a current process and new process. Company have to focus
on what type of outputs that are desired to achieve. For address that outcome a systematic plan
can develop by company.
Do- The do phase allows the plan from the previous step. In this planning and developed strategy
going to implement in action. Company actually implement plan in the real action so as desired
outcome can achieve (Jacobs, Swink and Linderman, 2015).
Check- Once the action has taken by the company then in the next stage it is very important to
check and monitor that action and activities.
Act- In this stage, company again take action to improve the activities and outcome.

5 Hazard analysis and critical control points
This technique mostly used in the process of food safety and protection. It is a systematic
preventive approach to food safety from biological chemical and physical hazard in production
processes (Chaudary, Zafar and Salman, 2015). It assists to the users to overcome the uncertain
hazard and risk from the food production so as high quality of food can deliver to the customers.
It can be used at all stage of a food chain including packaging, distributions, production etc. This
system allow both industry and government to allocate their resource in auditing of safe food
production procedure.
6 ICH objectives
There are major three objectives of ICH Q10 that is achieved product realization, Establish and
maintain a state of control and facilitate continual improvement (Haider and et.al., 2015). To
achieve product realization is one of the major objective of ICH Q10 under which system allows
the delivery of products with the quality so as patient requirement can effectively fulfill. It
implements in the process for improve quality of service so s patient can improve their health.
Another objective is to establish and maintain a state of control by which company can
effectively monitor the quality of services and process (Henry and Adewale. 2013). Quality risk
management can use to identify and monitor control system.
7 FMEA and its area of use ?
Implementation of FMEA in the process of production and manufacturing is to overcome
associated hazard and risk and improve quality of product and services. In a general term it can
be said that Failure mode and effects analysis is a structured way to identify and acknowledge
the associated risk and hazard in the production and manufacturing (Haider and et.al., 2015). It is
a effective in evaluating both new and existing process within the company. It is a structured was
to address the problem associated with the procedure through which quality and effectiveness
can automatically improve.
8 Quality risk management for facilities and equipments
The main aim of quality risk management and equipment is to eliminate the unwanted risk and
hazard from the business (Jacobs, Swink and Linderman, 2015). With help of this risk
management process, company can automatically overcome the hazard and uncertain hazard
from the services and product. There are various kinds of process, equipment and facilities that
can use by organization for improve the quality and overcome the unwanted hazard and risk

from the process. The most important aspect of risk management is to overcome uncertain risk
from the process, product and services.
9 Explanation about the corrective action and prevention action
The corrective and preventive action is the improvement to an organization processes
taken to eliminate causes of non conformity and other undesirable situation from the
organization. With help of this aspect uncertain hazard, risk and undesirable situation can easily
eliminate from the procedure (Assarlind and Gremyr, 2016). CAPA is generally used to being
improvement and efficiency within the organization process, product and services through which
objective can effectively address.
10 The activities that should be conducted to mange and continuously improve the
pharmaceutical quality system
The process and product quality monitoring system includes several activities that are as follows-
 Use superior risk management to establish the control strategy
 Supply the techniques for measurement and analysis of parameters (Assarlind and
Gremyr, 2016)
 Assessment if the parameters and attributes that is assessed in the control strategy
 Identification of the sources of variation that affect process performance and product
quality.
 In order to design space, it is provided knowledge and effective information.
11 The objective of FDA guidance on quality system approach to pharmaceutical GMP
regulation
The main objective of the FDA guidance on the quality system approach is to performing
and handling test protocols with chronic protocols. It assists in enhancing the speed and quality
of the process. It is responsible to protect the public health by ensuring the safety, efficacy and
security of human and veterinary drugs, biological products and medical devices. It ensures the
safety of our nations food supply, cosmetics and products.
12 Quality system models
The major aim of quality system model is to improve quality and effectiveness of the product
and services in the organization and eliminate wastage and additional cost from production and
manufacturing procedure within organization. (Chaudary, Zafar and Salman, 2015) There are
various kinds of the quality system model that is total quality management, six sigma, lean

production, ISO 9000, continuous quality improvement model, Kaizen, Bench marking etc.
These all models have main aim is to continuous improve efficiency and quality so wastage can
automatically eliminate. The quality system model gives all detail knowledge and information
regarding improvement in services and product in the organization.
13 How are nonconformities and deviation handled in any quality system
Nonconformities refer to the requirements of a project that are not fulfilled as per the
specifications. This in turn results in deviation from the previously undertaken plan to carry out
the project. Both of these occurrences should be completely avoided by referring to the 8
management standards of ISO9001 that emphasizes the organisations to accurately meet the
undertaken standards of quality where falling to rectify any non-conformity results in continuing
the errors by together resulting in increasing the costs required to entirely rework or replace the
project (Bo and et.al., 2015). This also leads to loss of consumers and quality accreditation, etc.
A CAPA program also known as corrective and preventive actions has been designed to handle
any such measures of deviation and non-conformities.
14 Explain the ISO standard related to risk management
The risks are known to make a negative impact on the organisations to a great extent. It directly
affects the economic performance of the organisation by together impacting upon its professional
status in the market. Beside this, it also brings negative environmental, societal and safety related
results at the workplace that in turn necessitates the firms to effectively manage such existing
risks and efficiently perform in such uncertain environment (Assarlind and Gremyr, 2016). For
this purpose, ISO has been framed with its standards involving the measures for managing risks.
ISO 31000 is referred to be the family of such significant principles and is codified by the
International Organisation for Standards. There are 2 such crucial aspects namely ISO
31000:2009 specifying the principles and general strategies for managing risks. Another is ISO
31010:2009 detailing the techniques related to the assessment and management of risks.
15 Describe in brief REMS
REMS is basically codified as Risk Evaluation and Mitigation Strategy which is mainly used
with a purpose of managing some severe risks that are associated with the risk of using any
biological product or drugs, etc. It is an obligatory norm which is required to be followed if

instructed by the Food and Drug Administration (Henry and Adewale. 2013). REMS mostly
includes a medication guide, communication plan along with a patient packaging system to
ensure a safe and secured use of organic or medicinal products. It together consists of a timetable
to assess the REMS with approval from FDA before using a newly introduced product. REMS
for one medication differs from that to the REMS of another medicine.
Section C
1 Quality management detail
This is the concept that is applied within organization for improve the productivity and
quality of product and services so as business can gain effective success and profit. It is a process
under which firm uses several approaches, systems and methods that can help to improve quality
of business and also improve customer satisfaction and loyalty for long term. It is very important
for company to use and implement effective methods and measures of quality management so as
desired outcome can obtain in effective and efficient manner (Bo and et.al., 2015). The major
component of quality management is quality planning, quality assurance, quality control and
quality improvement. Company have to focus on these elements of quality management for
increase the effectiveness and productivity of product and services. In a simple word it can be
said that this concept is the act of overseeing all activities and task required to maintain a desired
level of excellence. In order to implement measures and process of quality management,
company have to determine quality policy, creating and implement quality planning and
assurance and quality control and quality improvement.
2 Primary elements of Total quality management
Total quality management is the method of the quality management that helps to increase
efficiency and quality of product and services. In this aspect, all members of organization
participating equally within management process and improve quality and effectiveness of
product and services (Chaudary, Zafar and Salman, 2015) There are various elements o TQM
approach that required to focus by corporation. Total quality management elements includes
ethics, integrity, trust, training, team work, leadership, recognition and communication. Ethic is a
discipline concerned with good and bad in any situation. At the time of implementing quality
measures within company, organization have to follow some ethics. In addition to this, integrity
is another element that implies honesty, morals, values etc. Company have also focused on trust
and loyalty at the time of deliver product and service in the market. Organization also have to

focus on training and development, team work, leadership etc By focus on each element, firm
can successfully implement total quality management approach within company and improve
quality of product and services.
3 General quality risk management process as per ICH guidelines
Following are several stages of quality risk management process-
 Risk assessment- It is the first and significant stage under which information organize to
take a risk decision in the risk management. In this company suppose to identify risk
associated with process of business.
 Risk identification-This is the systematic use of information to identify potential source
of harm referring to the risk and problem (Haider and et.al., 2015).
 Risk analysis- It is the qualitative and quantitative procedure for linking the probability of
occurrence and severity of harm.
 Risk evaluation-In this stage company compare the estimated risk to given risk criteria by
use of qualitative and quantitative scale to identify the significance of the risk.
 Risk control- In this phase, company implements action for take risk management
decision. It has main purpose is to reduce the risk to an acceptable level.
 Risk reduction- In this stage, company revisit risk assessment in order to assess and
evaluate any required changes in the prices. It helps in overcome chance of risk within
the process.
 Risk acceptance- It refers to take the decision to accept the risk.
 Risk communication- In this information about the risk and risk management share
between the decision maker and other stakeholder.
 Risk review- In this stage company have to look upon the reviews that include
reconsideration of risk acceptance decisions. The process should be utilized for the
events.
4 GMPs and the concepts of modern quality systems
It discusses how modern, comprehensive quality systems provides for full compliance
with CGMP regulations. With help of this quality system, quality of product and services can
easily improve in effective and efficient manner (Jacobs, Swink and Linderman, 2015). In
addition to this, quality risk management is a valuable component of an effective quality system
framework.

5 Management responsibilities in quality system models
It is the great responsibility of management to understand the model of quality system in
order to gain effective results and outcome. It is also a responsibility of management to look
toward the process and significance of quality system model that assist to company in increasing
the quality and effectiveness of product and services. Management have to understand
implementation process of the quality system model and also they have responsibility to
measure and analyze the outcome after implement quality system approach within the business.
Effective application and selection of best model of quality system is very important in this
manner for gain effective outcome.
Module 8
Section A
1 Ideal frequency of conducting
A) 1-2 years
2 Tablets and capsules are susceptible to airborne contamination due to the
A) Improper storage facilities
3 A sterile drug product is
A) Non pyrogenic and contains viable microorganisms
4 When the organoleptic examination does not conclusive evidence the inspector shall have
sample tested using which method ?
c) Teratogenicity test
5 L.A.L stands for:
A Limulus Amebocyte Lysine
Section B
1 Define inspection and its objectives
An inspection is an activity that is organized to check and evaluate the exercise. In the
engineering activities, inspection involves the measurement tests and gauges applied to certain
characteristics in regard to an object and activity. Inspection includes the documented and each
inspection verified using a inspection test plan (Ji, Huang and Sun, 2015).
2 Objective of performing re inspection
The major objective of re inspection is to evaluate and analyze the performance of the
organization through which effective outcome can obtain. This method helps to evaluate and

monitor the performance and activities of the business within an organization. With help of re
inspection, company can re evaluate and monitor the activity through which high quality and
effective outcome can easily obtain.
3 Describe the roles and responsibility of the inspector
The inspector have major role and responsibility to check and monitor the each and every
activity and functions in the business. In addition to this, they read blueprint and specification.
They monitor operations to ensure that they meet production standard (Ji, Huang and Sun, 2015).
They have responsibility to test, inspect and measure material or product being produced. They
have also responsibility to accept and reject the items and remove all products and material that
fail to meet specification. Quality control workers record the result for their inspection through
test report. They monitor each and every activities in the business and make efforts to improve
quality of product and service.
4 What is the site master file ?
A site master file is the document that is prepared by the manufacturer and producer for
containing specific and factual GMP information about the production and control of
pharmaceutical manufacturing operations. It is generally used by the pharmaceutical
manufacture and should contain specific information about the policies and strategies of quality
management (Reijers, Mendling and Recker, 2015). By help of this site compete information
about the production, procedure and manufacturing can collect by the manufacturer. It provides
the production and control of pharmaceutical manufacturing information to the manufacturer
through which they can effectively carry out function and activities of the pharmaceutical.
5 Four classification of drugs and significance of national drug law
The national prescription law prerequisite association is an administration office in Nigeria
blamed for wiping out the creating, dealing with, manufacturing , offering, exchanging and
trafficking of hard pharmaceuticals. There are distinctive sorts of medicine that is
stimulants, barbiturates, antidepressants, depressants, narcoties, inhalants, cannabis et cetera.
Helpful prescriptions may be embraced by an authority briefly diagram and for utilize all the
ideal opportunity for steady condition.
6 Essential for pharmaceutical inspectorates to establish and maintain liaison with OMCL
• the Medical Devices Regulations 2002

• the General Product Safety Regulations 2005
These headings are prosperity controls under the Consumer Protection Act 1987 and hence, the
MHRA can investigate any business activity that is covered by these controls according to
the Consumer Rights Act 2015.
MHRA is the relegated fit master that coordinates and maintains the law on helpful contraptions
in the UK. It has an extent of investigatory and execution powers to ensure their security and
quality. If you are a maker arranged in the UK and you hope to supply restorative
contraptions in the UK or Europe then you should think about the going with controls:
To ensure that remedial contraptions put accessible and put into advantage in the UK meet these
regulatory necessities we play out the going with works out:
• assess all charges of opposition passed on to us, using a risk based structure.
• monitor the development of educated bodies relegated by MHRA to review the consistence
of producers
• investigate helpful contraptions on account of antagonistic or understanding showing a
potential issue
• carry out proactive peril based endeavors with other part states in Europe to recognize
creating threats
7 Method of sterilization process?
Cleansing is a method of demolition of a wide range of living microorganisms from a substance.
Purging is done to secure the substance for a long time without decay. The Sterile
Processing Department (Central Supply, or Sterile Supply as it is also known),
incorporates that organization inside the recuperating office in which therapeutic/cautious
supplies and rigging, both sterile and, are cleaned, prepared, arranged, secured, and issued
for tolerant care (Rosskopf and et.al., 2015).
Methods for Sterilization in specialist's offices are for watchful metallic instruments percolating,
autoclave, incineration ought to be conceivable (Safa and et.al., 2015). To prevent microbial
contamination in light of air. UV radiation lights for purification can be coordinated at the
passages. Purging is done to spare the substance for a long time without decay. Moreover, a
substance that isn't sterile, may contain living beings which may cause pollution when used
or controlled. So sanitization is fundamental. The microorganisms are imperceptible to
uncovered eye, and even those like minute living beings have a guarded sheath on their

surface making them impenetrable to cleansing. The life forms are subtle to uncovered eye,
and even those like tiny living beings have a protective sheath on their surface making them
impenetrable to disinfection.
8 What specific information should be evaluated for the cGMP compliance of intement, liquids
and lotions as per US GMP regulations
FDA made the redesignd CGMP heading to help ensure the shielded and sterile
collecting, planning, and holding of sustenance for human usage. Regardless of the way that this
control has not been revived in various years, it is adequately wide to apply to various conditions
that couldn't be envisioned at the bearing's start in 1969. Consistence with CGMP necessities is
essentially basic to the age of secured, sound sustenances. Current awesome collecting practice is
at the foundation of other preventive control measures, for instance, HACCP systems. The
working social event grasps the essentials of securing the flexibility of the CGMP bearing, yet
assumes that it is presently time to come back to the control and choose fitting updates to better
ensure a shielded and clean sustenance supply. The Food and Drug Administration last changed
the CGMP control for food in 1986. The essential part of the 1986 alteration was to develop new,
revived, or more point by point courses of action concerning sustenance industry workforce;
plants and grounds, clean workplaces, controls, and exercises; apparatus and utensils,
warehousing, and movement, and consistent or unavoidable defect levels. The Food and Drug
Administration last changed the CGMP control for food in 1986. The essential part of the 1986
alteration was to develop new, revived, or more point by point courses of action concerning
sustenance industry workforce; plants and grounds, clean workplaces, controls, and exercises;
apparatus and utensils, warehousing, and movement, and consistent or unavoidable defect levels.
segment of the clarifications behind undertaking this overview of the CGMP controls are
recorded underneath. The sustenance business has encountered broad change in the pretty much
quite a while since the sustenance CGMPs were rethought (Spofford Jr, Russell and Kelly,
2016). Arranged to-eat sustenances by and by address a greater piece of the American eating
schedule. Arranged to-eat new make servings of blended greens are a standard swap for plates of
blended greens orchestrated in the home. Refrigerated sustenances and warmth and-serve
sustenances are more standard than some other time in late memory. Today, purchasers will
presumably purchase sustenances that need essentially zero game plan or cooking before usage.
This infers if these sustenances are polluted with risky microorganisms, there may not be a

customer plan step that will abatement or wipe out the peril. Accordingly, more critical thought
must be paid to the importance of controlling foodborne pathogens in the midst of the gathering
and holding of sustenances, and for arranged to-eat sustenances particularly.
9 What are role does supervisory authority in Europe
The three European supervisory authorities, i.e. the European Banking Authority (EBA), the
European Insurance and Occupational Pensions Authority (EIOPA) and the European
Securities and Markets Authority give littler scale prudential supervision of the EU
budgetary markets close by the national supervisory specialists of the part states. While
advancing supervision of cash related establishments still rests with the national supervisory
specialists, the ESAs are depended with making and executing a run of the mill regulatory
structure and joined supervisory practice in the EU (Usichenko and et.al., 2013). The
particular piece of the ESAs is to provoke EU bodies in the definitive technique, make
regulatory rules and sort out national supervisory specialists.
10 Objective of site inspection as per UK MHRA
The MHRA shields general prosperity in the UK through the approving and prerequisite of
remedial things for human use, and usage of the laws relating to restorative contraptions.
The MHRA similarly controls clinical fundamentals of pharmaceuticals and restorative
devices. The UK Medicines and Healthcare things Regulatory Agency (MHRA) is an
official association of the UK Department of Health with commitment in regards to
supporting the advancing of meds and helpful devices in the UK and ensuring that these
meds and remedial devices work, and are acceptably secured.
11 Critical deficiency and major deficiency under UK MHRA
The UK remedy and social protection things regulatory association has released detail of GMP
evaluation deficiencies from a year back. The UK MHRA report gives the detail learning
and perception about the meds and other social protection thing systems. The objective of
Medicines and human administrations thing office have basic objective is to give suitable
care treatment and thing to the patient so as they can upgrade their restorative issue and
issue.

12 I.A.G
IAG quality report gives insight into the monitoring, assessment and quality of repair
standard across IAGs nationwide property and motor repair network. IAG is also using the latest
technology to help its customers recovers from incidents as quickly as possible.
The IAG Quality Report gives understanding into the watching, examination and nature
of repair rules over IAG's the nation over property and motor repair sort out. IAG is a quality
report that provides insight into the monitoring, assessment and quality of repair standards across
IAGs nationwide property and motor repair network. IAG quality report helps to provide high
quality of product and services to organization through which it can make high level of outcome
and effective productivity of business.
IAG has been placing assets into its Partner Repair Network since 2012 to pass on
protected, quality repairs and an unusual condition of customer advantage over the sum of its
brands. The motor and property repair associations. IAG Executive General Manager of Short
Tail Claims, Steve Fitzpatrick, said IAG is revolved around continually supporting its associate
repairers to also enhance their ability to pass on the most bewildering quality repairs and
organization for customers. IAG accessories with have the correct stuff, advancement, equipment
and resources for pass on powerful, stunning repairs for its customers the country over. IAG
similarly grasped .6,200 quality examinations of property repairs. Quality issues were recognized
in 2.56% of endorsed repairs and potential security issues in 0.05% of affirmed repairs. Where an
issue was recognized in the midst of an examination, IAG worked with repairers to redress them.
13 Language of the quality system audit reports according to health Canada ?
The audit report helps to the higher authority and management of organization in making
decision to improve a process or product in the most cost efficient way. The major objective of
audit is to analyze the situation, process and progress and take the decision accordingly within
the company. The language of the quality system audit report should be simple and clear so as
everyone can easily understand it. It is very important as it provides evidence that audits are
conducted in accordance with established audit schedules.
14 Role of the GMP inspectorates per Medicines control council of South Africa
The major role of the GMP inspectorates as per medicine control council of South Africa
is to evaluate and monitor the performance of activities and function so as effective outcome can
obtain. They are also responsible to establish and implement an effective pharmaceutical quality

assurance system. They have responsible to provide and maintain premises and equipment
appropriate to the intended operation. They also maintain an effective system whereby
complaints are reviewed and products may be recalled. They have also responsibility to carry out
a program of regular self-inspection. They have to maintain premises and equipment appropriate
to the intended operation.
15 The principles of self-inspection as per medicines control council of South Africa
The major objective of the self-inspection is to evaluate the manufacture's compliance with GMP
in all aspects of production and quality control. With help of these principles, organization can
improve quality and effectiveness of the product and services and achieve determined objective
in effective and efficient manner. As per the medicines control council of south Africa, this
principle promote the safety and security within the production and manufacturing operation
within the business through which company can easily improve quality of product and services
and earn maximum profitability and productivity within the competitive business environment.
Section c
a) Types of audits
Audit is an examination of a present structure, report, or substance. There are different sorts of
surveys that can be coordinated, including the going with:
•Compliance audit This is an examination of the procedures and strategies of a substance or
office, to check whether it is in consistence with inside or authoritative standards. This audit
is most ordinarily used as a piece of coordinated organizations or educational associations.
•Construction survey. This is an examination of the costs gained for a specific advancement
wander. Activities may join an examination of the attentions surrendered to legally binding
laborers, costs paid, overhead costs contemplated reimbursement, change orders, and the
comfort of realization. The objective is to ensure that the costs gained for an errand were
sensible.
• Financial survey- This is an examination of the sensibility of the information contained inside
a substance's cash related clarifications. It is driven by a CPA firm, which is self-governing
of the component under review. This is the most normally coordinated sort of survey.
•Information systems audit- This incorporates a review of the controls over programming
progression, data planning, and access to PC structures. The arrangement is to recognize any

issues that could cripple the limit of IT systems to give correct information to customers,
and notwithstanding ensure that unapproved parties don't approach the data.
•Investigative survey- This is an examination of a specific region or individual when there is an
uncertainty of tasteless or phony development. The arrangement is to discover and cure
control breaks, and notwithstanding assemble affirm if charges are to be brought against
some individual.
•Operation audit-This is a point by point examination of the destinations, orchestrating
techniques, frameworks, and results of the assignments of a business. The audit may be
driven inside or by an external substance. The normal result is an appraisal of assignments,
likely with recommendations for advancement.
b) The qualification of the drug inspectors
Drug supervisor is the master who is responsible for checking the quality and capability
of the drug from its amassing till to date of offer. They have commitment to screen the
practicality and adequacy of the solution from its amassing till its arrangement at the retail shop.
The medicine inspector must have ability in Bachelor degree in Pharmacy. Likewise, B
tranquilize store and equivalent course should be class run with Physics, science and science as
standard subjects. A practical and compelling pharmaceutical controller should have show
industriousness, obligation to surpass desires in their individual field and confidence. Hopefuls
must have capacity to convincing watching, examination, appraisal and confidence through
which they can perform in feasible and beneficial route at workplace. They have furthermore
nature of educate and they ought to have confidence through which they can without a lot of a
stretch convey high bore of work and they ought to be completely educated in regards to the
event in field of pharmaceutical and other related advancements.
c) Organizational aspect of the drug inspectors
The food and drug inspector is also known as the quality control inspector who have
responsibility to check and monitor the quality and effectiveness of product and services. They
have main responsibility is to check and monitor the quality and effectiveness of product and
services. In the organization, drug inspector have responsibility to achieve determined objective
by delivering high quality of services and product to customers.

d) Current good manufacturing regulation as per US FDA
FDA ensures the idea of solution things by means of decisively watching medicine makers'
consistence with its Current Good Manufacturing Practice bearings. The CGMP headings
for drugs contain minimum necessities for the methodologies, workplaces, and controls used
as a piece of gathering, getting ready, and squeezing of a medicine thing. The bearings
guarantee that a thing is okay for use, and that it has the fixings and quality it cases to have .
•The support process for new and non-particular drug advancing applications joins a review of
the maker's consistence with the CGMPs. FDA assessors and specialists choose if the firm
has the imperative workplaces, equipment, and ability to deliver the prescription it intends to
exhibit.
•CGMP suggests the Current Good Manufacturing Practice bearings executed by the US Food
and Drug Administration (FDA). CGMPs suit systems that certification authentic blueprint,
watching, and control of collecting methods and workplaces. Adherence to the CGMP
headings ensures the identity, quality, quality, and ethicalness of prescription things by
requiring that makers of meds acceptably control manufacturing errands. This fuses
developing strong quality organization systems, procuring reasonable quality unrefined
materials, setting up capable working strategy, recognizing and investigating thing quality
deviations, and keeping up reliable testing labs.
Current extraordinary amassing practice course gives structures that certification authentic
arrangement, checking and control of collecting strategies and workplaces. This control ensures
the recognize, quality, quality and righteousness of pharmaceutical things This system
consolidates developing strong quality organization structures, getting fitting quality unrefined
materials, setting up fiery working procedures, perceiving and exploring thing quality deviations,
and keeping up trustworthy testing labs. This formal course of action of controls at a
pharmaceutical association, if enough get under way, turns away events of contamination,
botches, deviations, frustrations, and bumbles. This assurances sedate things meet their quality
measures.
e) Determination for the laboratory controls in order to conform with appropriate standard
Good delivering practice helps in the prosperity and care relationship in protecting the
patient from the risk and other danger. Awesome amassing determined ensures that they get
restorative things f uncompromising high bore. Consistence with these quality measures is

fundamental in the midst of the make, getting ready, packaging and limit of therapeutic things.
Collecting endorsement will be denied to any association that fails to agree to GMP controls.
This is spoken to wherever all through the world by shows of law, controls and guidelines issued
by government bodies, administrations and worldwide affiliations. They will most likely put
shielded and effective remedial things accessible with no harm to the patients. Every
employee must know, follow and implement GMP regulation and rules so as effective process
can conduct within the organization. It assists in improving the security and safety for patient so
as they can improve their health issues and problem in an effective manner.
Module 9
Section A
1 Set of authorize written procedure
A) Protocol
2 Which of the following is not a type of Drug master file as per US FDA
A) Manufacturing site, facilities , operating procedure and personnel
3 The batch production and laboratory control record should be reviewed and approved by
A) Quality Unit
4) Which of the Sub part of 21 CFR parts 211 contain record and reports ?
A) Subpart E
5) In which level company policies are ordered in Hierarchical document system ?
A) Level 3
Section B
1 Need of documentation in pharmaceutical industry
With help of documentation, information can easily record and collect in the pharmaceutical
industry. The main objective of documentation is to define procedure in written to the
pharmaceutical manufacturer so as errors and risk can easily minimize. With help of
documentation, manufacturing process and quality related activities are carried out in the similar
manner as they are planned and approved. A systematic documentation provides an effective
knowledge of the history and present status of manufacturing batches. In addition to this an
effective documentation provide required information regarding drug product and services
through which organization can effectively keep their records.

2 WHO good distribution practices for pharmaceutical products
Assignment is a basic development in the consolidated stock system organization of
pharmaceutical things. Distinctive people and components are overall responsible for the
managing, limit and dissemination of such things. Now and again, regardless, a man or
component is simply connected with and accountable for particular segments of the
assignment method. The objective of these guidelines is to help with ensuring the quality
and identity of pharmaceutical things in the midst of all parts of the allotment system. These
points consolidate, yet are not obliged to, securing, acquiring, limit, course, transportation,
repackaging, relabelling, documentation and record-keeping practices
The storage, sale and distribution of the pharmaceutical product are often carried out by various
companies, institution and individuals.
3 The difference between standard operating procedure and protocol?
The standard working system is a precise procedure of rule that orchestrated by association to
enable workers to finish complex routine errands (Chaudary, Zafar and Salman, 2015). The
critical purpose of standard working procedure is to achieve adequacy, quality yield and
consistency of execution
4 Describes the control of Document as per ISO 9001-2003
As per the ISO 9001 and 2003, documented information is a meaningful data that is
required to controlled and maintained by the company .This information can use by organization
for address their objective (Chaudary, Zafar and Salman, 2015). This information may related to
the product and services, procedure, objective, system etc. In the company every one have
access of the information so as they can effectively carry out function and activities and achieve
determined objective in excellent manner. With help of this documented information in the
organization, management can improve quality of the product and services.
5 Describes the record for storage condition and stock control
Record of storage condition and stock control helps to the organization in managing stock
and raw materiel of organization so as it can deliver at right time, right place and right person.
With help of effective record of stock control and storage condition, company can easily manage
and produce product and services with help of sufficient raw material and semi finished goods.
Efficient stock control allows organization to have the right amount of stock in the right place

and at the right time. There are major four type of stock that is raw material, work in progress,
finished goods and consumables.
6 Description about Drug master file and site master file
A drug master file is document that contain information regarding the food and drug
administration. This document generally used to provide effective information regarding the
processes, facilities, packaging, production, manufacturing etc for the organization. With help of
this document, manufacturer can get the detail knowledge and understanding about the several
activities in the food and drug administration (Assarlind and Gremyr, 2016). In addition to this, a
site master file is a document that is prepared by the manufacturer in order to collect and record
information about pharmaceutical process and operation. It contains a detail knowledge about the
pharmaceutical manufacturing activities through which producer can get detail about the same
aspect.
7 Record for raw material and intermediates
Raw material is very significant in the manufacturing and production process by which
company can produce the finished goods. Raw material inventory is majorly used in the
manufacturing and production activities by which effective product and services can produced by
the organization (Assarlind and Gremyr, 2016). In addition to this, intermediaries is the person
who creates the link between the parties. An intermediary is the third party that create contact
and communication among two parties.
8 What is the complaints record and discuss the information to be included in these records
Complaints record is that record in which information regarding the mistake and issues
within the process. Complaints is the statement in which individual express dissatisfaction with a
particular situation. In addition to this, a complaint is a reason for complaining and it refers to an
illness as complaints (Bo and et.al., 2015). In this record includes information regarding
customer feedback, comments, reviews etc.
9 Describes the specification for starting material, intermediate product, packaging material and
finished products as per PICS
Starting material - Raw materials are foundations of finished products. It includes packaging,
processing, etc. it is important that product must meet the regulator requirements.
Intermediate product- It contains the inner product that is the core product. It must be kept
safely in container so that it does not get infected.

Packaging material - the packaging of product must be done in such a way that it does not harm
core product. The containers must provide adequate protection against deterioration or
contamination of intermediate product.
Finished products – the finished product must be according to the standards that are set by
government.
10 Format of SOP and list out the information to be mentioned in SOP
The Standard operating procedure, also known as the SOP is the effective tools or the
document that help in maintaining the quality by an organisation. (VanVactor, 2013.) It helps in
covering the details of the specialization and the processes that are been followed within an
organisation to maintain the manufacturing process and assure the quality of the services that are
been followed. Some major and vital information that is been mentioned in SOP and is followed
within the enterprise are:
 Objective of SOP.
 Scope in relation to the activity that is been performed or for which it is developed.
 Responsibilities
 Accountability covering the manager of HOD.
 Procedures that is been followed by the firm
 Abbreviations if any used.
11 Batch manufacturing record view
The company has to see through the effective handling and assessment of the actions and
activities that are been followed within the enterprise, this helps in the good rise in the activities
or the processes that are been followed by the organisation (Bo and et.al., 2015). It helps in the
effective assessment of the quality and quantity of the batch that is been manufactured and
actions that are been followed, which will help in the good assessment of the actions and the
procedures that are taken in consideration by the firm. It helps in maintaining the uniformity by
the organisation and support effective handling of SOP.

12 Common technical document and describes the different module of CTD
It is an application or the documentation that helps in the better rise in the activities and
meeting of the targeted goals and actions and followed by a medical or pharmaceutical
organisation. It is the internationally agreed format and intend to provide the effective detailed
information about the medicine and followed by various authorities like FDA, Ministry of health
and welfare etc. the various modules of a CTD are:
 Administrative and prescribing information
 Overview and summary of modules 3 to 5
 Quality details
 Preclinical tests details
 clinical tests details
These modules help in effective management of the operations and the activities that are
been followed by the organisation in a better way.
13 Documentation of extemporaneously prepared product
The different types of the documentation is been followed by the organisation that will
help in good rise in the quality and ensure the delivery of a safe batch by the pharmaceutical firm
(Tasman, 2008). The Documentation of extemporaneously prepared product involves the details
of the usage, legal consideration, therapeutic substitution, procurement options and clinical risk
reduction measures caused by the in appropriate following of operations and thus has to be
managed effectively by the organisation that will help in the better rise in the actions and
operations of the organisation. Other than this, the formulation and preparation details are been
included in the firm.

14 Describe the record for recall and returned product
The pharmaceutical firm has to effectively look after the different measures to handle the
returned and recalled product by the firm. The complaints are required to be mitigated and
handled with extreme care that will help in good rise in the customer satisfaction level. And
remove the quality related issues from the firm.
On the other hand, the decision related to the recalling the product and services are to be
managed and handle with effective and extreme care as this can impact the revenue generation,
market presence and reputation of the company (Assarlind and Gremyr, 2016). Returned
products should be reassessed and evaluated to find out the reason of rejection and rectify it in
order to meet the requirements of the customers or the dealer.
15 The electronic manufacturing and batch records
The electric batch record system will help in good assessment of the various business
operations and actions that are been followed by the firm. It helps in managing the different sort
ODF data that are been developed within the firm and thus will help in rise in the customer
satisfaction level, improving the effectiveness of the pharmaceutical firm and development of
high quality medicines.
Section C
1 Laboratory control record and WHO guideline for preparing laboratory information file
Lab control record Laboratory records are the game plan of record that constitute of made
declarations out of general objectives and course as portrayed or given by the affiliation or
organization (Haider and et.al., 2015). Lab records contain the entire information from the
period of getting a rough material to collecting of a pharmaceutical measurements outline.
Research focus records are along these lines orchestrated into a couple of sorts of records
like group records, expert gathering record, cluster delivering records et cetera
2 Detail note on US FDA guideline on drug master file
The sustenance and prescription association is an office inside the US which contains the work
environment of the judge and four directorates that controlling the middle components of
office. The Food and Drug Administration (FDA) is responsible for guaranteeing the general

prosperity by ensuring the prosperity, sufficiency, and security of human and veterinary
meds, natural things, therapeutic contraptions, our nation's sustenance supply, enhancing
operators, and things that transmit radiation. The FDA also gives correct, science-based
prosperity information to the all inclusive community
3 Master production and control records
Mater production is the plan for individual communities to be produced in each time period
such as production, staffing and inventory etc. With help of this master production, individual
can get the detail knowledge and understanding about the production and manufacturing
activities and facilities in the business enterprise.
4 Complaints file and laboratory records as per records and reports sub parts of 21 CFR
In the 21 CFR complaints file and laboratory record is very important through which
individual can take effective knowledge and information about the subject. Complaints file
provides the idea about the improvement area within the business by which individual can make
necessary changes within it (Jacobs, Swink and Linderman, 2015). In addition to this laboratory
notebooks and record is the document that provides the knowledge regarding hypotheses,
experiments, initial analysis and interpretation of these experiments.
5 Batch production and manufacturing and batch packaging record in detail
Batch production is on of the effective aspect in the manufacturing and packaging by
which customer can get the detail knowledge and understanding about the product and services
which company actually deliver (Sheehan and Griffiths, 2011).
Gathering Production Records are genuine copies of a Master Production Record that are used to
document the specific information for each individual group.

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Online
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