Basic Concepts of Quality Assurance and Quality Control

Definitions Quality Assurance: According to WHO, quality

assurance is a wideranging concept covering all matters that
individually or collectively influence the quality of a product.
With regard to pharmaceuticals, quality assurance can be
divided into major areas: development, quality control,
production, distribution, and inspections. ISO 9000 defines as
"part of quality management focused on providing confidence
that quality requirements will be fulfilled
Definition:
Quality Control: 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 & testing,
documentation & release procedures which ensure
that the necessary & relevant tests are performed &
the product is released for use only after ascertaining
it’s quality
 Difference between QA and QC Definition
QA is a set of activities for ensuring quality in the
processes by which products are developed. QA is a
managerial tool QC is a set of activities for ensuring
quality in products. The activities focus on identifying
defects in the actual products produced. QC is a
corrective tool
 Difference between QA and QC (Contd.)
What are its goals and on what does it focus?

• QA aims to prevent • QC aims to identify (and

defects with a focus on correct) defects in the
the process used to make finished product. Quality
the product. It is a control, therefore, is a
proactive quality process. reactive process.
• The goal of QA is to • The goal of QC is to
improve development identify defects after a
and test processes so that product is developed and
defects do not arise when before it's released.
the product is being
developed.
 Difference between QA and QC
(Contd.) What and how does it work?
• Prevention of quality • The activities or
problems through techniques used to
planned and systematic achieve and maintain the
activities including product quality, process
documentation. and service. Finding &
Establish a good quality eliminating sources of
management system and quality problems through
the assessment of its tools & equipment so that
adequacy. Periodic customer's requirements
conformance audits of are continually met.
the operations of the
system.
 Difference between QA and QC (Contd.)
Whose responsibility is it and what is the example of it?

• Everyone on the team • Quality control is

involved in developing usually the
the product is responsibility of a
responsible for quality specific team that tests
assurance. the product for defects.
• Verification is an • Validation is an example
example of QA. of QC.
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.
Responsibilities of QA (Contd.)
• QA functions to assess operations
continually and to advise and guide
them towards full compliance with
all applicable internal and external
regulations.
Responsibilities of QC 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
labelling. They conduct in-process testing
when required, perform environmental
monitoring, and inspect operations for
compliance. They also conduct the required
tests on finished dosage form.
Responsibilities of QC (Contd.) QC plays a major
role in the selection of qualified vendors from
whom raw materials are purchased. Testing of
representative samples is required, and in many
cases, an audit of vendor’s operations is necessary
to determine their suitability and degree of
compliance with GMPs prior to their being
approved. The environmental areas for
manufacturing of various dosage forms are tested
and inspected by QC department.
GOOD MANUFACTURING
PRACTICES [GMP] FOR
PHARMACEUTICALS
CONTENTS • Current GMP in manufacturing
processes • Packaging and holding of drugs •
Finished pharmaceuticals • General provisions
• Organization and personnel • Building and
facilities • Equipment • Control of components
• Containers and closures • Production and
process control • Packaging and labeling
control • Holding and distribution • Records
and reports • Returned savaged drug products
• The inspection for compliance with GMP
regulations • Controlled substances safeguards
• References
Introduction

What is GMP ? (Good Manufacturing Practices)

• GMP is that part of Quality assurance which
ensures that the products are consistently
manufactured and controlled to the Quality
standards appropriate to their intended use •
A set of principles and procedures which,
when followed by manufacturers for
therapeutic goods, helps ensure that the
products manufacture will have the required
quality.
Good Manufacturing Practices • A basic tenet
of GMP is that quality cannot be tested into a
batch of product but must be built into each
batch of product during all stages of the
manufacturing process. • It is designed to
minimize the risks involved in any
pharmaceutical production that cannot be
eliminated through testing the final product.
Some of the main risks are – 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.
Why GMP is important • A poor quality
medicine may contain toxic substances that
have been unintentionally added. • A medicine
that contains little or none of the claimed
ingredient will not have the intended
therapeutic effect.
 GMP

QA, GMP & QC inter-relationship It is the sum total of the organized arrangements
with the objective of ensuring that products will be of the quality required for
their intended use
QA, GMP & QC inter-relationship
Is that part of GMP concerned with sampling,
specification & testing, documentation &
release procedures which ensure that the
necessary & relevant tests are performed &
the product is released for use only after
ascertaining it’s quality
 QC and QA
• QC is that part of GMP • QA is the sum total of
which is concerned with organized arrangements
sampling, made with the object of
specifications, testing ensuring that product
and with in the will be of the Quality
organization, required by their
documentation and intended use.
release procedures
which ensure that the
necessary and relevant
tests are carried out
 QC and QA
• Operational laboratory • All those planned or
techniques and systematic actions
activities used to fulfill necessary to provide
the requirement of adequate confidence
Quali that a product will
• QC is lab based. satisfy the requirements
for quality
• QA is company based
GMP • The Quality of a formulation or a bulk
drug depends on the Quality of those
producing it • GMP is the magic key that opens
the door of the Quality • In matter of GMP,
swim with the current and in matter of Quality
stand like a rock!
GMP helps boost pharmaceutical export
opportunities • Most countries will only accept
import and sale of medicines that have been
manufactured to internationally recognized
GMP. • Governments seeking to promote their
countries export of pharmaceuticals can do so
by making GMP mandatory for all
pharmaceutical production and by training
their inspectors in GMP requirements.
GMP Covers… • All aspects of production; from
the starting materials, premises and
equipment to the training and personal
hygiene of staff. • Detailed, written procedures
are essential for each process that could affect
the quality of the finished product. • There
must be systems to provide documented proof
that correct procedures are consistently
followed at each step in the manufacturing
process - every time a product is made.
2014/02/18 Faculty
GMP guidelines • GMP as per Schedule “M” •
GMP as per WHO • GMP as per MCA now
known as MHRA • GMP as per TGA • GMP as
per US FDA • GMP as per ICH guidelines WHO:
World Health Organization MHRA: Ministry of
Health and Regulatory Affairs TGA: Therapeutic
Goods Affairs FDA: Food And Drug
Administration ICH: International Conference
on Harmonization
GMP guidelines • GMP as per Schedule “M”
www.cdsco.nic.in • GMP as per WHO
www.who.int • GMP as per MCA now known
as MHRA www.mca.gov.uk • GMP as per TGA
www.tga.gov.au • GMP as per US FDA
www.fda.gov • GMP as per ICH guidelines
www.ich.org
GMP • GMP in solid dosage forms • GMP in
semisolid dosage forms • GMP in Liquid orals •
GMP in Parenterals Production • GMP in
Ayurvedic medicines • GMP in Bio
technological products • GMP in
Nutraceuticals and cosmeceuticals
Ten Principles of GMP 1. Design and construct
the facilities and equipments properly 2.
Follow written procedures and Instructions 3.
Document work 4. Validate work 5. Monitor
facilities and equipment 6. Write step by step
operating procedures and work on instructions
7. Design ,develop and demonstrate job
competence 8. Protect against contamination
9. Control components and product related
processes 10. Conduct planned and periodic
audits
List of important documents in GMP • Policies
• SOP (Standard Operating Procedure) •
Specifications • MFR (Master Formula Record)
• BMR (Batch Manufacturing Record) •
Manuals • Master plans/ files • Validation
protocols • Forms and Formats • Records
10 attributes of a good document 1. Accurate
2. Clear 3. Complete 4. Consistent 5. Indelible
6. Legible 7. Timely 8. Direct 9. Authentic 10.
Authorized
What are cGMPs? • cGMP refers to the Current
Good Manufacturing Practice regulations
enforced by the US Food and Drug
Administration (FDA). • cGMP provide for
systems that assure proper design, monitoring
and control of manufacturing processes and
facilities. • Adherence to the cGMP regulations
assures the identity, strength, quality and
purity of drug products by requiring that
manufacturers of medications adequately
control manufacturing operations
Why are cGMP so important • A consumer
usually cannot detect (through smell, touch, or
sight) that a drug product is safe or if it will
work. • While cGMPs require testing, testing
alone is not adequate to ensure quality. • In
most instances testing is done on a small
sample of a batch (for example, a drug
manufacturer may test 1000 tablets from a
batch that contains 2 million tablets), so that
most of the batch can be used for patients
rather than destroyed by testing.
Packaging and holding of drugs • Care shall be
taken when using automatic tablet and capsule
counting, strip and blister packaging
equipment to ensure that all ‘rogue’ tablets,
capsules or foils from packaging operation are
removed before a new packaging operation is
commenced. • There shall be an independent
recorded check of the equipment before a new
batch of tablets or capsules is handled.
Finished pharmaceuticals Appropriate
specifications for finished products shall
include: - • The designated name of the
product and the code reference. • The formula
or a reference to the formula and the
pharmacopoeial reference. • Directions for
sampling and testing or a reference to
procedures.
General provisions • The processing of dry
materials and products creates problems of
dust control and crosscontamination. Special
attention is therefore, needed in the design,
maintenance and use of premises and
equipment in order to overcome these
problems. Wherever required, enclosed dust
control manufacturing systems shall be
employed.
Organization and personnel 1. Responsibilities
of quality control unit. 2. Personnel
qualifications. 3. Personnel responsibilities. 4.
Consultants.
Building and facilities 1. Design and
construction features. 2. Lighting. 3.
Ventilation, air filtration, air heating and
cooling. 4. Plumbing. 5. Sewage and refuse. 6.
Washing and toilet facilities. 7. Sanitation. 8.
Maintenance.
Equipment 1. Equipment design, size, and
location. 2. Equipment construction. 3.
Equipment cleaning and maintenance. 4.
Automatic, mechanical, and electronic
equipment. 5. Filters.
Control of components 1. General
requirements. 2. Receipt & storage of untested
components, drug product containers and
closures. 3. Testing and approval or rejection of
components, drug product containers and
closures. 4. Use of approved components, drug
product containers, and closures. 5. Retesting
of approved components, drug product
containers, and closures. 6. Rejected
components, drug product containers, and
closures. 7. Drug product containers and
closures.
Containers and closures • All containers and
closures intended for use shall comply with the
pharmacopoeial requirements. Suitable
validated test methods, sample sizes,
specifications, cleaning procedure and
sterilization procedure, wherever indicated,
shall be strictly followed to ensure that these
are not reactive, additive, absorptive, or leach
to an extent that significantly affects the
quality or purity of the drug. No second hand
or used containers and closures shall be used.
Production and process control 1. Written
procedures; deviations. 2. Charge-in of
components. 3. Calculation of yield. 4.
Equipment identification. 5. Sampling and
testing of in-process materials and drug
products. 6. Time limitations on production. 7.
Control of microbiological contamination. 8.
Reprocessing.
Packaging and labeling control 1. Materials
examination and usage criteria. 2. Labeling
issuance. 3. Packaging and labeling operations.
4. Tamper-evident packaging requirements for
over-the-counter (OTC) human drug products.
5. Drug product inspection. 6. Expiration
dating.
Holding and distribution 1. Warehousing
procedures. 2. Distribution procedures.
Holding and distribution • Prior to distribution
or dispatch of given batch of a drug, it shall be
ensure that the batch has been duly tested,
approved and released by the quality control
personnel. Pre-dispatch inspection shall be
performed on each consignment on a random
basis to ensure that only the correct goods are
dispatched. Detailed instructions for
warehousing and stocking of Large Volume
Parenterals, if stocked, shall be in existence
and shall be complied with after the batch is
released for distribution. Periodic audits of
warehousing practices followed at distribution
centers shall be carried out and records
thereof shall be maintained. Standard
Operating Procedures shall be developed for
warehousing of products.
Records and reports 1. General requirements.
2. Equipment cleaning and use log. 3.
Component, drug product container, closure,
and labeling records. 4. Master production and
control records. 5. Batch production and
control records. 6. Production record review. 7.
Laboratory records. 8. Distribution records. 9.
Complaint files.
Returned savaged drug products 1. Returned
drug products. 2. Drug product salvaging.
Returned savaged drug products • Adequate
areas shall be designed to allow sufficient and
orderly warehousing of returned or recalled
products. • Segregation shall be provided for
the storage of rejected, recalled or returned
materials or products.
The inspection for compliance with GMP
regulations • Short description of the self
inspection system indicating whether an
outside, independent and experienced
external export was involved in evaluating the
manufacturer’s compliance with Good
manufacturing Practices in all aspects of
production. • Periodic inspection of the
garments shall be done by responsible staff.
Controlled substances safeguards • Hazardous,
toxic substances and flammable materials shall
be stored in suitably designed and segregated,
enclosed areas in conformity with Central and
State Legislations. • Highly hazardous,
poisonous and explosive materials such as
narcotics, psychotropic drugs and substances
presenting potential risks of abuse, fire or
explosion shall be stored in safe and secure
areas. Adequate fire protection measures shall
be provided in conformity with the rules of the
concerned civic authority.