1. PREPARED BY:- GUIDE BY:-
PATEL BHAVIN RAJESH PARMAR
M.PHARM SEM-1
DEPARTMENT OF QUALITY ASSURANCE
A.P.M.C COLLEGE OF PHARMACEUTICAL SCIENCE &
RESEARCH,
HIMMATNAGAR.

2.  1.Quality Assurance
 2.GMP
 3.GLP

3.  Quality Assurance is a wide ranging concept
covering all matters that individually or
collectively influence the quality of product.
 “ It is the totality of the arrangement made
with the object of ensuring that pharmaceutical
products are of the quality required for their
intended use”
 QA is the heart and soul of the quality control.
 QA=GCP + GLP + GPP + GMP + any other
measure to achieve intended quality.

4.  Pharmaceutical products are designed and
developed in a way that takes account of the
requirement of GMP and other associated codes
such as those of good laboratory practice (GLP) and
good clinical practice (GCP)
 Product and control operations are clearly specified
in a written form and GMP requirements are
adapted.
 Managerial responsibilities are clearly specified in
job descriptions.

5. Arrangements are made for the manufacture, Supply and use
of correct starting and packaging material.
All necessary controls on starting material, intermediate
products and bulk products and other in process controls,
calibrations , and validation are carried out.
The finished product is correctly proceed and checked
according to the defined procedure.
Pharmaceutical products are not sold or supplied before the
authorized persons have certified that each productions batch
has been produced and controlled in accordance with the
requirement of the marketing authorization and any other
regulations relevant to the productions, control and release of
Pharmaceutical products.

6. Satisfactory arrangements exist to ensure, as far as possible,
that the pharmaceutical products are stored by the
manufacture, distributed and sub-sequent handled so that
Quality is maintained throughout their shelf life.
There is a procedure for self inspection and/or quality audit
that regularly appraises the effectiveness and applicability of
the QA system.

7.  Quality Assurance is independence of
manufacturing.
 In process quality is checked during
manufacturing.
 Validation of facilities, Equipment , Process
,Products and cleaning as per master plan.
 Compliant handling.
 Storage of Quality record and control samples.
 Stability studies.
 Registration documents

8. 1. Technology transfer
2. Validation
3. Documentation
4. Quality Improvement plans
5. Assuring Quality of the Products

9. 1. Technology transfer
 Receipt of product design documents from
research centre.
 Distribution of documents received from the
research centre.
 Checking and approval of documents
generated based on research centre document.
i.e. batch manufacturing records.
 Scale up and validation of product.

10. 2.Validation:
Preparation of Validation plans for facility,
equipments/process including cleaning.
Approval of protocol for Validation of
facility/equipments/product/process.
Team member for execution of validation of
facility/equipments/product/process

11. 3. Documentation control:
 Control distribution and achieving of
documents.
 Control of changes made by proper change
control procedure.
 Approval of document.

12. 4. Quality Improvement plans:
 Feedback received from the compliance team
 Proposals for corrective and preventive actions
 Annual products review
 Trend analysis of various quality parameter for
products , environment and water.

13. 5. Assuring Quality of the Products:
 CGMP training
 SOP compliance
 Audit of facility for compliance
 Line clearance
 In-process counter checks
 Critical sampling
 Record verification.
 Release of batch for marketing
 Investigation of market complaints

14. GMP
(Good Manufacturing
Practice)

15. “Good Manufacturing Practice is that part of
quality assurance which ensures that products
are consistently produced and controlled to the
quality standards appropriate to their intended
use and as required by the marketing
authorization”

16. GMP is aimed primarily at diminishing the risks inherent in
any pharmaceuticals production.
Such risks are essentially of two types:
(1)Cross contamination (in particular of unexpected
contaminants)
(2)Mix-ups (confusion Caused by, for example, false labels
being put on containers.

17.  All manufacturing process are clearly defined
 Qualifications and validation are performed
 All necessary resources are provided
(1) Appropriately qualified and trained personnel;
(2) Adequate premises and space;
(3) Suitable equipment and services;
(4) Appropriate materials, containers and labels;
(5) approved procedures and instructions;
(6) Suitable storage and transport;
(7) Adequate personnel, laboratories and
equipment for in process controls;

18.  Instructions and procedures are written
 Operators are trained to carried out procedure
correctly
 Records are made
 Storage and Distribution
 Recall
 Complaints

19.  Conformance to the predetermined specifications
 To eliminate errors
 To improve efficiency
 To reduce costs
 To prevent risks
 To minimize contamination
 To produce product of consistent quality

20. (GLP)
GOOD
LABORATORY
PRACTICE

21. “A quality system concerned with the
organizational process and the conditions
under which non-clinical health and
environmental safety studies are planned,
performed, monitored, recorded, archived and
reported.”

22.  To promote the development of quality test
data and to provide a managerial tool to ensure
a sound approach to the management
 Set of criteria to be satisfied as a basis
 To allocate roles and responsibilities in order to
improvement
 To focus on those aspects of study excretion

23. The GLP principles in their strict, regulatory sense
apply only to such studies on pharmaceuticals which:
 Are non-clinical, i.e. are mostly conducted in
animals or in vitro, and include analytical aspects.
 Are conceived to obtain data on the properties
and/or safety with respect to human health and/or
the environment of the testing substances.
 Are intended to be submitted to a national
registration authority for the purposes of
registering or licensing the tested substance or any
product derived from it.

24.  In general and depending upon national legal
requirements, the GLP requirements for non-
clinical laboratory studies conducted for the
safety evaluation in the field of drug safety
testing cover the following classes of studies:
 Single dose toxicity.
 Repeated dose toxicity (sub-acute and chronic).
 Reproductive toxicity (fertility, embryo-foetal
toxicity and teratogenicity, perinatal /postnatal
toxicity).
 Mutagenic potential.

25.  Carcinogenic potential.
 Toxicokinetics (pharmacokinetic studies which
provide systemic exposure data for the above
studies).
 Pharmacokinetic studies designed to test the
potential for adverse effects (safety
pharmacology).
 Local tolerance studies, including photo
toxicity, irritation and sensitization studies, and
testing for suspected addictively and/or
withdrawal effects of drug.

26.  Apply to the relevant studies planned and
conducted in a manufacturer’s laboratories
 Strict adherence to GLP will remove many sources
of error and uncertainty
 The requirement to formulate a study plan with a
defined purpose of study will prevent false starts
and diminish the incidence of incomplete or
inconclusive studies.
 Respecting the GLP principles will thus indirectly
optimize the scientific yield of such studies.

27.  Annex 4 GMP for pharmaceutical products, WHO
Guidelines
 GLP , Handbook of GLP, Quality practices for regulated non
clinical research and development
 How to practice GMPs 4th Edition By P.P. Sharma.
 How to practice GLP By P.P.sharma , Vandana Publication.