Lab 1

Quality Management
Quality Assurance &
Quality Control In
Pharma Industry
 Objectives
• Understand the concepts of:
• Quality management
• Quality assurance
• GMP
• Quality control
• Standard operation procedure (SOP)
and write sop.
Story of Quality
 What is Quality Management?
 The aspect of management function that
determines and implements the “quality policy”

 Authorized by top management

The quality policy is a statement by the top management of the

company of its overall intentions and direction relating to quality, formally
expressed as a corporate policy. The top management of a company
usually includes the board of directors or general manager of the
company, the plant or factory”
 In Quality Management
• Quality assurance is a management tool
• QA, GMP and Quality Control are interrelated
aspects of Quality Management
QA

GMP

QC
QUALITY ASSURANCE (Q.A.)
 General concept of QA

QA
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
QUALITY ASSURANCE (Q.A.)

• Q.A. is a wide ranging concept covering all

matters that influence the quality of a product.
• Q.A. incorporates GMP, QC.
• The Q.A. department is responsible for
ensuring that the quality policies.
• Q.A. plays a major role in the identification
and preparation of the necessary policies and
standard operating procedures (SOPs) relative
to the control of quality.
 QA System should ensure that:
• Products are designed and developed in
accordance with GLP, and GMP
• Production and control operations are clearly
specified in SOPs
• Managerial responsibilities are clearly specified
in job descriptions
• Systems ensure that the correct starting and
packaging materials are used
 QA System should ensure:

• Starting materials, intermediate products, bulk products

are controlled
• In-process controls, calibrations, and validations are
carried out.
• Finished products are correctly processed and checked.
• Systems ensure that products are appropriately stored and
distributed.
 QA System should ensure:
• Self-inspection and/or quality audits are done
regularly
• Deviations are reported, investigated and
recorded
• Changes are controlled
• Systems are followed to verify the consistency of
processes and ensuring continuous improvement
• Quality Risk Management is implemented
Good Manufacturing
Practices (GMP)
(ICH Guidelines)
(WHO Guidelines)
 Good Manufacturing Practices (GMP)

That part of QA that ensures that products are

consistently produced and controlled:
Quality standards
Marketing authorization
Aim: Diminishing risks that cannot be controlled
by testing of product
Contamination and cross-
contamination
Mix-ups (confusion)
 Basic Requirements for GMP – I
• Clearly defined and systematically reviewed
processes
• Qualification and validation is performed
• Qualified and trained personnel
 Premises, space, equipment and services
 Materials, containers, labels
 Procedures, storage, transport
 Laboratories and in-process control
 Basic Requirements for GMP
• Clear, written instructions and procedures
• Trained operators
• Records of actions, deviations and
investigations
• Records for manufacture and distribution
• Proper storage and distribution
 We can say
GMP
Is that part of Quality
Assurance aimed at
ensuring that products
are consistently
manufactured to a
quality appropriate to
their intended use
 QC
Is that part of GMP
concerned with sampling,
specification & testing,
documentation & release
procedures which ensure
that the necessary &
relevant tests are
performed.
 QA and QC

• QA is the sum total of QC is that part of GMP •

organized which is concerned
arrangements made with sampling,
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. procedures which
ensure that the
necessary and relevant
tests are carried out
 QA and QC

• QA is company QC is lab based •

based
 DOCUMENTATION
Main objective
to establish, monitor and record “Quality”
for all aspects of Good Laboratory
Practices and Quality Control”.
Type of documents
Standard operating procedures
Protocols of tests, results
Reports
Standard Operation
Procedure (SOP)
How to write Standard Operating
Procedure
 Format of an SOP
Title : descriptive

Code : Number relating to procedure and revisions

Objective : Aim of the procedure clearly described

Scope : The operating unit and field of application

Definitions: Meaning of principle terms used

Description : Operating instructions clearly described without any

ambiguity, understood by all staff with flow diagrams

Safety : Measures to be kept in mind when executing the SOP

Documentation : Protocol, Data sheets and measurements

References : Used to draw up the SOP

 Format on each page of
SOP
• Logo and name of the organization
• Department or unit issuing the SOP
• Title and date of issue
• Signature of person who drew up the SOP
• Signature of person who reviewed it
• Signature of person who authorized it
• Duration of validity
• Date of review
• Code
• Page number and total number of pages in
the document
• SOP for Hand Wash Procedure
Standard operating procedure to clean the hands before and after the
work.
1.0 OBJECTIVE
To clean the hand before starting the work in their respective place.
2.0 SCOPE
This procedure is applicable for all employee ﴾personnel ﴿working in
Quality Control Laboratory.
3.0 RESPONSIBILITY
3.1 Doing : All personnel working in laboratory
3.2 Checking : Executive / Manager
4.0 ACCOUNTABILITY
Head of the Department
5.0 PROCEDURE
5.1 After following the gowning procedure as per S.O.P., wash the hands
with liquid soap by using soap dispenser lying at respective toilet.
5.2 Dry the hand with help of drier kept at respective toilet.
5.3 After using toilet, also wash hands as per above procedure.
5.4 After completion of work, follow the same procedure.
6.0 ABBREVIATIONS
• 6.1 S.O.P. = Standard operating procedure
6.2 Q.C. Lab = Quality Control Laboratory
 Examples of SOP

qc 16 17\Sample SOP, Example SOP, SOP Format, SOP

Template _ Pharmaceutical Guidelines.pdf

qc 16 17\SOP for Hand Wash Procedure.pdf

qc 16 17\SOP for Top Pan Balance.pdf

 REFERENCES
• www.ich.org
• www.fda.gov
• www.who.org