Introduction to QA and QC

Ms. Shweta s. kale

Quality Assurance

GMP

Quality CONTROL

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 Quality
Signifies excellence of product /service
which is based on consumers experience
with the product /service against his or
her requirement.
 DEFINITIONS
• Quality is the totality of features and characteristics of a product or
service that bear on its ability to satisfy given needs (ASQ) and/or
implied needs
Value to the Customers

• Quality Assurance: all those planned or systematic actions

necessary to provide adequate confidence that a product or
service will satisfy given needs (ASQ)
• The sum total of the organized arrangements made with the
object of ensuring that medicinal products are of the quality
required for their intended use.

Making sure that Quality is what it should be

 Quality Assurance

It is a quality management tool or system which organizes

overall activity of company or organization or industry in a

such way that , they assure the management that the activity

being performed as designed in the organization.

Process oriented and focuses on defect prevention.

 Quality Control
It deals with the system which accept or reject any

activity which effect the quality of the product.

Product oriented and focuses on defect

identification.
 Comparison Between QA & QC
Focus on QA aims to prevent defects with a
focus on the process used to make
the product. It is a proactive quality
process.
The goal of QA is to improve
development and test processes so
Goal that defects do not arise when the
product is being developed.
Establish a good quality management
system and the assessment of its
How adequacy. Periodic conformance
audits of the operations of the
system.
QC aims to identify defects
in the finished product,
RM,Pakaging product.
Quality control, therefore, is
a reactive process.
The goal of QC is to identify
defects after a product is
developed and before it's
released.
Finding & eliminating
sources of quality
problems through tools &
equipment so that
customer's requirements
are continually met.
 The activities or
Prevention of quality
techniques used to
problems through planned
What they do achieve and maintain
and systematic activities
the product quality,
including documentation.
process and service.

Quality control is
Everyone in the team usually the
involved in developing the responsibility of a
Responsibility
product is responsible for specific team that
quality assurance. tests the product for
defects.

Validation/Software
Verification is an example
Example Testing is an example
of QA
of QC

As a tool QA is a managerial tool
Orientation QA is process oriented
Statistical Tools &
Techniques can be applied in
both QA & QC. When they
are applied to processes
Statistical
(process inputs &
Techniques
operational parameters),
they are called Statistical
Process Control (SPC) & it
becomes the part of QA.
QC is a corrective
tool
QC is product
oriented
When statistical tools
& techniques are
applied to finished
products (process
outputs), they are
called as Statistical
Quality Control
(SQC) & comes
under QC
 Quality Assurance
• A process, not an end-point
• Must be independent of financial pressures
• Must ensure that quality policies are followed
• Must have final authority in product acceptance,
rejection and release to public
• Integral to production
• Responsible for day-to-day operations and for longer
term goal settings
• Quantitative discipline with specified parameters

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 Quality Assurance
Primary Functions
• Quality Control
• Analytical testing of products

• Active and Non active material control

• Sampling, inspecting and testing of incoming raw materials

• Packaging and labeling components

• Bottles, caps, foils, labels, measures, cartons

• Physical inspection of product and operations at critical intermediate

stages
• In-process controls, HACCP(Hazards analysis and critical control points)

• Control of product through its distribution

• GSP, GDP ETC

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Elements of the Quality Assurance Cycle in
Pharmaceutical Manufacturing
• Research
• Development
• Documentation
• Raw Materials
• Facilities
• Equipment
• Personnel and Supervision
• Monitoring, Feedback, Follow-up

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Quality Assurance: Essential At All Stages

Quality Assurance Cycle

Research
Development
Raw Materials
Facilities
Documentation
Equipment
Personnel

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Quality relationships

QA
GMP
QC

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 GMP
Part of Quality Assurance which ensures that products are
constantly produced and control to the quality standards
appropriate to their intended use and required by the
marketing authorization.

Primarily used to,

Diminished the risk in pharmaceutical product which can
not be prevented completely in final testing as,
----Contamination (unexpected)
---- Mix-up (confusion)
 What is GMP? (WHO)
• Comprehensive system for ensuring products are
consistently produced and controlled according to
quality standards
• Designed to minimize risks involved in any
pharmaceutical production that cannot be eliminated
through testing of final product alone
• Cross-contamination

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 The Breadth of GMP

Covers all aspects of production including

• Raw or starting materials

• Finished products
• Premises and environment
• Equipment
• personnel
• Training
• Hygiene 22
 GMP Principles
• Must be built into manufacturing process
• Prevents errors that cannot be eliminated through
quality control of finished product
• Ensures all units of a medicine are of the same
(within specified parameters) quality
• Poor medicines leads to loss of credibility for
everyone: manufacturers, health care workers and
governments
• WHO Guidelines for GMP

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 WHO Technical Guide to GMP
• First prepared in 1967
• Updated and revised regularly
• “Quality Management in the Drug Industry” outlines
general concepts and principle components of GMP
• “Good practices in production and quality control”
describes implementation

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 WHO Technical Guide to GMP
General Consideration
“Licensed pharmaceutical products should be
manufactured only by licensed manufacturers whose
activities are regularly inspected by competent national
authorities”

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 WHO Technical Guide to GMP
Key Concepts
• Validation
Action of proving (in accordance with principles of
GMP) that any procedure, process, equipment,
material, activity, or system actually leads to
expected results

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 WHO Technical Guide to GMP
Key Concepts
• Qualification
Action of proving that any premises, system, and
items of equipment work correctly and actually lead
to expected results

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 Key Elements of GMP
(WHO Technical Guide)

• Sanitation and hygiene

• Qualification and validation
• Complaints
• Product recalls
• Contract Production and Analysis
• Self-Inspection and Quality Audits

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Key Elements of GMP (WHO Technical Guide)

Personnel
(Training, Hygiene)

Documentation Premises
(Equipment)
Materials
(Supplies, Ingredients)

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GLP (Good Laboratory Practices)
Need to be used in laboratory.

Purpose

Testing the Physical, chemical and microbial

nature of the material and avoid hazards to
human.
 DEFINITIONS
• GOOD MANUFACTURING PRACTICE (GMP)
• That part of QA which ensures that products are
consistently produced and controlled to the quality
standards appropriate to their intended use.
• QUALITY CONTROL
• That part of GMP which is concerned with sampling,
specifications and testing.

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Quality relationships

Quality Management

Quality Assurance

GMP

Quality Control

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 FACTORS IN DRUG QUALITY ASSURANCE

MANUFACURING
LEGISLATIVE PROCESSES
FRAMEWORK & PROCEDURES QC &
-REGULATIONS ANALYSIS

HUMAN
RESOURCES-
PROFESSIONALS STORAGE

DRUG
RAW PRODUCT
MATERIALS- QUALITY
ACTIVE & PACKAGING
INACTIVE

LABELLING &
IMPORT PRODUCT
TRANSPORT INFROMATION
& EXPORT
DISTRIBUTION
CONTROL
DISPENSING
& USE 37
 GCP (Good Clinical Practices)
Set of Guidelines for biomedical studies.

Aim
 To ensure that the studies are scientifically &
ethically sound.
 Investigations are properly documented.
 Protection of rights of human subjects in clinical
trials.
 Authenticity of biomedical data generated under
biomedical study.
Quality Must Be Designed Into A Product

• Quality is not an add-on: it begins with research and

development
• Product quality criteria must be established
• Detailed specifications provide quantitative
parameters for measurement
• Written procedures document how quality is
attained and maintained
• Continuous monitoring (sampling, testing) to
confirm quality is being built-into product

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 Manufacturing Process and Procedures

• Dispensing / Weighing
• Mixing / Granulation / Preparation
• Compression / Encapsulation / Filling
• Equipment, Operational & Process
Qualification
• Validation & calibration
• Documentation and record keeping
• Yield Reconciliation

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 Stability Definitions (1)
• Capability of a particular formulation of a
pharmaceutical in a specified container/closure
system to remain within specified physical, chemical,
microbiological, therapeutic and toxicological
specifications

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 Stability Definitions (2)
• The time from the date of manufacture and
packaging of the formulation until its chemical or
biological activity is not less than a predetermined
level (generally, 90%) of labeled potency and its
physical characteristics have not changed appreciably

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