1.
Quality Assurance and Quality Management concepts
BP606T
Unit-1
Part-1
(Definition and concept of Quality control,
Quality assurance and GMP)
Snigdha Rani Behera
Associate Professor
ARKA JAIN UNIVERSITY

2.
Quality Assurance and Quality Management concepts
Definition: Quality is fitness for use and freedom from deficiencies.
 Quality is a property which decides excellence or inadequacy (inferiority or
superiority) of product or services.
 J.M.Juran (1970) who is father of quality research has defined “quality as the
performance of the product as per the commitment made by the producer to
consumer”.
 The quality of a pharmaceutical product is determined by the quality of the raw
materials, equipment, and the technical knowledge required to process, package, and
distribute the product.
 To maintain the quality we need to maintains four parameter.
 Quality Management
 Quality Assurance
 GMP
 Quality Control
ARKA JAIN University, Jamshedpur, Jharkhand

3.
Quality Control:
 A system of maintaining standards in manufactured products by testing a
sample of the output against the specification.
 It is defined as Process to maintain required quality of product or service. It is a
systematic control of various factors that affect the quality of the product.
 ISO 9000 defines quality control as "A part of quality management focused
on fulfilling quality requirements ".
 It is that part of GMP concerned with sampling, specification and testing,
documentation and release procedures which ensure that the necessary and
relevant tests are performed and the product is released for use only after
ascertaining its quality.
ARKA JAIN University, Jamshedpur, Jharkhand

4.
Objectives of Quality Control:
 Reduced errors and establish quality and standard products.
 Analyses extent of quality deviations in process.
 Evaluation of methods and process of production.
 Promote cost reduction.
 Production of quality goods accelerates sale of goods.
 Inspire more effective teamwork.
 Promotion of exports due to superior and standard quality Production.
ARKA JAIN University, Jamshedpur, Jharkhand

5.
Steps of Quality Control
QC Labs Sampling Validation
Batch
Inspection&
Sampling
Retained
Samples
Analysis of
Finished
Product
Records
ARKA JAIN University, Jamshedpur, Jharkhand

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Responsibilities of Quality Control:
 QC is responsible for the day-to-day control of quality within the company.
 This department is responsible for analytical testing of incoming raw materials
and inspection of packaging components, including labeling.
 They conduct in-process testing when required, perform environmental
monitoring, and inspect operations for compliance.
 QC plays a major role in the selection of qualified vendors from whom raw
materials are purchased.
 The environmental areas for manufacturing of various dosage forms are tested
and inspected by QC department.
ARKA JAIN University, Jamshedpur, Jharkhand

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 Any variation in the quality of a product are mainly due to variations in
raw material, personal, methods and procedure of production and
inspection.
 In order to produce the quality product, these variations need to be
checked and controlled.
 There are seven types of primary quality control tools.
ARKA JAIN University, Jamshedpur, Jharkhand

8.
Methods or Tools of Quality Control
Pareto Charts
Fishbone
diagram/
Ishikawa
diagram
Check sheets
Control charts
Stratification
Histogram
Scatter diagram
Flow charts
ARKA JAIN University, Jamshedpur, Jharkhand

9.
1.Pareto Charts:
 A Pareto chart, named after Vilfredo Pareto, is a type of chart that contains both
bars and a line graph, where individual values are represented in descending order
by bars and the cumulative total is represented by the line.
 Visual analysis of problems can be done by this type of bar charts so that you can
target on most significant issues.
 This is the method of organizing errors, problems or defects to help to focus on
problem solving efforts.
ARKA JAIN University, Jamshedpur, Jharkhand

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2.Fishbone diagram/ Ishikawa diagram:
 It is invented by Kaoru Ishikawa.
 It is otherwise known as cause and effect diagram.
 It helps to determine to which problem is associated, whether it is material,
machine , process or Manpower i.e. Personnel.
ARKA JAIN University, Jamshedpur, Jharkhand

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3. Check sheet:
 It is a simple document that is used for collecting data in real time and location
where the data is generated.
 The document is typically a blank form that is designed for quick, easy and
efficient recording of the desired information, which can be either quantitative or
qualitative.
 It helps to check crucial material required to manufacture and sell products.
 Data checking by checklist is first step in analysis of quality problem.
ARKA JAIN University, Jamshedpur, Jharkhand

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4.Control charts:
 A control chart is a statistical tool used to distinguish between variation in a
process resulting from common causes and variation resulting from special
causes.
 The charts helps you find and correct problems as they happens, predict a range
of out comes and analyze variations.
ARKA JAIN University, Jamshedpur, Jharkhand

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5.Stratification:
 It simplifies process by separating data so that you can identify problem
areas.
ARKA JAIN University, Jamshedpur, Jharkhand

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6.Histogram:
 It looks very much like a bar chart.
 Its graphical method showing bars to recognize defect and frequency of
areas.
ARKA JAIN University, Jamshedpur, Jharkhand

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7. Scatter diagram:
 It show the relationship between two measurements.
 If the items are closely related the data points will form a tight band and if a
random pattern results, the items are unrelated.
 These are often used to determine whether a stated cause truly dose impact
the quality characteristics.
ARKA JAIN University, Jamshedpur, Jharkhand

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8.Flow chart:
 Flow charts are often used to diagram operational procedures to simplify
the system.
 It shows the sequence of events in a process.
ARKA JAIN University, Jamshedpur, Jharkhand

17.
Quality Assurance
Quality Assurance :
 According to WHO, quality assurance is a wide- ranging concept covering
all matters that individually or collectively influence the quality of a
product.
 Quality Assurance is systematic process to ensure whether a product or
service will fulfill their intended quality and desire requirements will be
met.
 According to ISO 9000 STANDARDS defines QA as “A part of quality
management focused on providing confidence that quality requirements
will be fulfilled.”
 With regard to pharmaceuticals, quality assurance can be divided into
major areas: development, quality control, production, distribution, and
inspections.(WHO)
ARKA JAIN University, Jamshedpur, Jharkhand

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Principle of QA:
 To ensure that pharmaceutical products are of the quality required for their
intended use.
 Quality assurance therefore incorporates GMP and other factors, including those
outside the scope of this guide such as product design and development.
 1. Product should suitable for intended purpose i.e Fit for purpose.
 2.Mistakes should be eliminated i.e. Right first time.
Objectives of QA:
 Supervising good manufacturing Practices. (GMP)
 Inspecting good laboratory practices. (GLP)
 Monitoring plant environment.
 Verifying quality of raw materials.
 Verifying the quality of finished product.
 Ensure a safety programmed.
ARKA JAIN University, Jamshedpur, Jharkhand

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Function of QA:
Master plan for entire process is prepared.
Standards for all raw material and finished products are designed.
It provides services to all areas relevant to product quality.
Managing and approval of documentations.
ARKA JAIN University, Jamshedpur, Jharkhand

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Components of QA:
Components of QA
Strategic Level Tactical Level Operational
Level
Quality Police Training, Facility,
Operation of QA SOP’s Worksheet
ARKA JAIN University, Jamshedpur, Jharkhand

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Methods for Quality Assurance:
There are three methods for Quality Assurance.
1. Failure testing
2. Statistical process control (SPC)
3. Total quality management (TQM)
4. Failure testing:
 Testing the product under heat, pressure or vibration to ensure its physical
strength .
 For software products, failure testing might involve placing the software under
high usage or load conditions.
2. Statistical process control (SPC):
 It is a method based on objective data and analysis.
 It is use to manage and control the production of products.(It is mainly used
statistical methods)
ARKA JAIN University, Jamshedpur, Jharkhand

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3. Total quality management (TQM):
TQM is the integration of all functions and processes to achieve
continuous improvement of the quality of goods and services.
Responsibilities of QA:
 The QA department is responsible for ensuring that the quality policies
adopted by a company are followed.
 It helps to identify and prepare the necessary SOPs relative to the control
of quality.
 It must determine that the product meets all the applicable specifications
and that it was manufactured according to the internal standards of GMP.
 QA also holds responsible for quality monitoring or audit function.
 QA functions to assess operations continually and to advise and guide
them towards full compliance with all applicable internal and external
regulations
ARKA JAIN University, Jamshedpur, Jharkhand

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Responsibilities of QA:
 All necessary controls on starting materials, intermediate products, and
bulk products and other in-process controls, calibrations, and validations
are carried out.
 The finished product is correctly processed and checked, according to the
defined procedures.
 Satisfactory arrangements exist to ensure, as far as possible, that the
pharmaceutical products are stored by the manufacturer, distributed, and
subsequently handled so that quality is maintained throughout their shelf-
life.
 Deviations are reported, investigated and recorded.
 There is a system for approving changes that may have an impact on
product quality.
 Regular evaluations of the quality of pharmaceutical products should be
conducted with the objective of verifying the consistency of the process
and ensuring its continuous improvement.
ARKA JAIN University, Jamshedpur, Jharkhand

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GMP
 Good Manufacturing Practice is a part of quality assurance which ensure
that the products are consistently produced and controlled according to
quality standards appropriate to their intended use.
 A set of principles and procedures which, when followed by
manufacturers for the therapeutic goods, helps ensure that the products
manufactured will have the required quality.
 According to WHO Main principles of GMP is “that part of quality
management which ensures that products are consistently produced and
controlled according to the quality standards appropriate to their intended
use and as required by the marketing authorization, clinical trial
authorization or product specification” .
 GMP is aimed primarily at managing and minimizing the risks inherent in
pharmaceutical manufacture to ensure the quality, safety and efficacy of
products. ARKA JAIN University, Jamshedpur, Jharkhand

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The Govt. of India amended the drugs & cosmetics rules 1945 on 24th
June 1988 and prescribed GMPs under schedule M.
Schedule M has 2 parts i.e. Part-I & Part-II.
GMP guidelines comes under Part-I
Aim of GMP:
 Diminishing the risks inherent in pharmaceutical production, which may
broadly be categorized in to
 Unexpected contamination of products, causing damage to health or even
death.
 Incorrect labels on containers, which could mean that patients receive the
wrong medicine.
 Insufficient or too much active ingredient, resulting in ineffective
treatment or adverse effects.
ARKA JAIN University, Jamshedpur, Jharkhand

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Objective of GMP:
 To produce products confirming to the predetermine specific objective.
 To produce product of consistent quality.
 To minimize contamination.
 To eliminate errors.
Components of GMP:
ARKA JAIN University, Jamshedpur, Jharkhand

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GMP
1.Quality
management
2.QA
3.GMP for
Medicinal
products
4. QC
5.Sanitation
& Hygiene
6.Qualification
& Validation
7.Complaints
& Product
recall
8.Contract
production &
Analysis
9. Self- Inspection,
Quality audits &
supplier’s audits &
approval
10.Personnel &
Training
11.Premises
12.Equipme
nt
13.Materials 14.Docume
ntation
15.Holding
&
Distribution
ARKA JAIN University, Jamshedpur, Jharkhand

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3.GMP for Medicinal products
 GMP is aimed primarily at managing and minimizing the risks inherent in
pharmaceutical manufacture to ensure the quality, safety and efficacy of
products.
 All manufacturing processes are clearly defined, systematically reviewed
for associated risks in the light of scientific knowledge and experience,
and shown to be capable of consistently manufacturing pharmaceutical
products of the required quality that comply with their specifications.
 Qualification and validation are performed.
ARKA JAIN University, Jamshedpur, Jharkhand

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3.GMP for Medicinal products
 All necessary resources are provided, including:
(i) Sufficient and appropriately qualified and trained personnel,
(ii) Adequate premises and space,
(iii) Suitable equipment and services,
(iv) Appropriate materials, containers and labels,
(v) Approved procedures and instructions,
(vi) Suitable storage and transport,
(vii) Adequate personnel, laboratories and equipment for in-process controls;
 SOPs shall be maintained.
 All equipment shall be labeled with their current status.
 Critical process are validated
 Second person verification of activities.
 Self- inspection programmed
ARKA JAIN University, Jamshedpur, Jharkhand

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4.QC Department:
 Quality control responsibility
 Testing of Bulk components prior to use by production.
 Testing of finished product prior to release for sale.
 Stability program.
 Review batch records, labels.
 Release product, based on QC test results.
 Training, auditing.
 Customer complaints.
ARKA JAIN University, Jamshedpur, Jharkhand

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5.Sanitation & Hygiene
 A high level of sanitation and hygiene should be practiced in every aspect
of the manufacture of medicines.
 The scope of sanitation and hygiene covers personnel, premises,
equipment and apparatus, production materials and containers, products
for cleaning and disinfection, and anything that could become a source of
contamination to the product.
 Potential sources of contamination should be eliminated through an
integrated comprehensive programme of sanitation and hygiene.
ARKA JAIN University, Jamshedpur, Jharkhand

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5.Personal Hygiene
 Health examination.
 Before & during employment.
 Periodic eye examinations for those who do visual inspection.
 Training
 Practice in personal hygiene
 Written procedures and instructions.
 Wash hand before entering production area.
 Signs in area (Changing room, Wash areas, Toilet facilities)
 Before entering production area use disinfectant.
 Direct contact between product and operator should be avoided.
ARKA JAIN University, Jamshedpur, Jharkhand

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6.Qualification & Validation
 The term Qualification is normally used for equipment, utilities and
systems.
 Validation is normally used for a processes. So qualification is a part of
validation.
 Validation requires an appropriate and sufficient infrastructure including
organization, documentation, Personnel and finances.
 Qualification should be completed before process validation is performed.
 A logical, systematic process should be followed.
 Start from the design phase of the premises, equipments, utilities and
equipment.
 Major equipment and critical utilities and systems normally require IQ,
OQ and PQ.
ARKA JAIN University, Jamshedpur, Jharkhand

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7.Complaints & Product recall
 All complaints and other information concerning potentially defective products
should be carefully reviewed according to written procedures and the corrective
action should be taken.
 A SOP should be available giving full details about how to handle products
complaints and necessary records about complaints handled should be
maintained.
 A person should be designed for handling the complaints and deciding the
measures to be taken together with sufficient supporting staff.
 If product defect is suspected in a batch, other batches should also be checked in
order to determine whether they are also affected.
 All decisions and measures taken as a result of a complaint should be recorded.
 Recall is an action taken to withdraw/remove the drugs from distribution or use
including corrective action for which deficiencies are reported in quality,
efficiency or safety.
 Products which are already distributed or sold, may require at times to be recalled
from market.
ARKA JAIN University, Jamshedpur, Jharkhand

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ARKA JAIN University, Jamshedpur, Jharkhand
8.Contract production & Analysis
 Contract production, analysis and any other activity covered by GMP
must be correctly defined, agreed and controlled in order to avoid
misunderstandings that could result in a product, or work or analysis, of
unsatisfactory quality.
 All arrangements for contract production and analysis, including
technology transfer and any proposed changes in technical or other
arrangements, should be in accordance with the marketing authorization
for the product concerned.
 The contract should permit the contract giver to audit the facilities and
activities of the contract acceptor or mutually agreed subcontractors.
 In the case of contract analysis, the final approval for release must be
given by the authorized person in accordance with GMP.

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9.Self- Inspection, Quality audits & supplier’s audits &
approval
 The purpose of self-inspection is to evaluate the manufacturer’s
compliance with GMP in all aspects of production and QC.
 It should be performed routinely, and may be, in addition, performed on
special occasions.
 e.g. In the case of product recalls or repeated rejections, or when an
inspection by the health authorities is announced.
 Quality audit is useful to supplement self-inspections.
 quality audit consists of an examination and assessment of all or part of a
quality system with the specific purpose of improving it.
 The person responsible for QC should have responsibility, together with
other relevant departments, for approving suppliers who can reliably
supply starting and packaging materials that meet established
specifications.
ARKA JAIN University, Jamshedpur, Jharkhand

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10.Personnel &Training
 The establishment and maintenance of a satisfactory system of QA and the
correct manufacture and control of pharmaceutical products and active
ingredients rely upon people.
 The manufacturer should have an adequate number of personnel with the
necessary qualifications and practical experience.
 Responsible staff should have its specific duties recorded in written
descriptions and adequate authority to carry out its responsibilities.
 The manufacturer should provide training in accordance with a written
programme for all personnel whose duties take them into manufacturing
areas or into control laboratories (including the technical, maintenance and
cleaning personnel) and for other personnel as required.
ARKA JAIN University, Jamshedpur, Jharkhand

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11.Premises
 Premises must be located, designed, constructed, adapted and maintained
to suit the operations to be carried out.
 The layout and design of premises must aim to minimize the risk of errors
and permit effective cleaning and maintenance in order to avoid cross
contamination.
 Ancillary areas
 Rest and refreshment rooms should be separate from manufacturing and
control areas.
 Storage areas
 It should be of sufficient capacity to allow orderly storage of the various
categories of materials and products with proper separation and
segregation.
ARKA JAIN University, Jamshedpur, Jharkhand

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11.Premises
 i.e. from Starting and packaging materials, intermediates, bulk and
finished products, products in quarantine, and released, rejected, returned
or recalled products.
 Weighing areas
 The weighing of starting materials and the estimation of yield by weighing
should be carried out in separate weighing areas designed for that use.
 Production areas:
 To minimize the risk of a serious medical hazard due to cross
contamination, dedicated and self-contained facilities must be available
for the production of particular pharmaceutical products.
 Quality control areas
 QC laboratories should be separated from production areas. Areas where
biological, microbiological or radioisotope test methods are employed
should be separated from each other.
ARKA JAIN University, Jamshedpur, Jharkhand

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12.Equipment
 Equipment must be located, designed, constructed, adapted and
maintained to suit the operations to be carried out.
 The layout and design of equipment must aim to minimize the risk of
errors and permit effective cleaning and maintenance in order to avoid
cross-contamination.
 Equipment should be installed in such a way as to minimize any risk of
error or of contamination.
ARKA JAIN University, Jamshedpur, Jharkhand

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13.Materials
 The main objective of a pharmaceutical plant is to produce finished
products for patients’ use from a combination of materials (starting and
packaging).
 Materials include starting materials, packaging materials, gases, solvents,
process aids, reagents and labelling materials.
 All materials and products should be stored under the appropriate
conditions established by the manufacturer, and in an orderly fashion, to
permit batch segregation and stock rotation by a. first-expire, first-out rule.
ARKA JAIN University, Jamshedpur, Jharkhand

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14.Documentation
 Good documentation is an essential part of the quality assurance system
and, as such, should exist for all aspects of GMP.
 Its aims are to define the specifications and procedures for all materials
and methods of manufacture and control.
 It ensures the availability of the data needed for validation, review and
statistical analysis.
 Documents should be designed, prepared, reviewed and distributed with
care.
 Documents should be approved, signed and dated by the appropriate
responsible persons. No document should be changed without
authorization and approval.
ARKA JAIN University, Jamshedpur, Jharkhand

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15.Holding & Distribution
 Storage and distribution are important activities in the supply chain
management of medical products.
 Products may be subjected to various risks at different stages in the
supply chain, i.e. during purchasing, storage, distribution, transportation,
re-packaging, and re-labelling.
 It is essential to protect the supply chain against the penetration of such
products.
ARKA JAIN University, Jamshedpur, Jharkhand

44.
THANK YOU
STAY SAFE
&
STAY HEALTHY
ARKA JAIN University, Jamshedpur, Jharkhand