TQM AND GMP

1. QUALITY ASSURANCE and GOOD
MANUFACTURING PRACTICE
MANISH KUMAR SHARMA
M. Pharmacy (pharmaceutics)

2. CONTENTS
1. Quality assurance
- principles of QA
- basic requirements
- QA, GMP & QC relationship
2. Good manufacturing practice
-principle
-list of documents & comparison of
various GMPs
-basic considerations

3. QUALITY ASSURANCE

4. QA covers all matters which individually or
collectively influence the quality of a product.
All parts of QA system should be adequately
resourced with Competent personnel, Suitable
& sufficient premises, equipment & facilities.

5. Principles of Quality Assurance (QA)
 Wide-ranging concept
Covers all matters that individually or
collectively influence the quality of a product
 Totality of the arrangements
To ensure that the drug is of the right quality
for the intended use

6. BASIC REQUIREMENTS OF QA
Ensure that products are designed and developed based on
sound scientific rationale and with GMP or GLP principles being
taken into consideration.
Ensure that managerial responsibilities are clearly specified.
Ensure that production and control operations are clearly
specified and GMP is adopted.
Organize supply & use of correct starting & packaging materials.
Ensure that finished products are correctly processed & checked
before release.
Ensure that products are released after review by authorized
person.
Put in place a mechanism for regular self inspection / internal
quality audit.

7. QA, GMP & QC inter relationship

8. GOOD
MANUFACTURING
PRACTICE

9. DEFINITION: Good manufacturing practice is a part
of the quality assurance, and being to ensures that
products are produced and controlled to the quality
standards appropriate to their intended use and as
required by the essential elements of its marketing
authorization or product specification.
 GMP contains the quality of the organization &
processes involved in manufacture.
 GMP covers all aspects of manufacture including
collection, transportation, processing, storage, QC &
delivery of the finished product.

10. List of important documents in GMP
 Policies
 SOP
 Specifications
 MFR (Master Formula Record)
 BMR (batch manufacturing records)
 Manuals
 Master plans/ files
 Validation protocols
 Forms & Formats
 Records

11. How do GMPs of different countries compare?
At a high level, GMPs of various nations are very
similar; most require things like:
 Equipment & facilities being properly designed,
maintained, & cleaned
 SOPs be written & approved
 An independent Quality unit (like QC and/or QA)
 Well trained personnel & management

12. I. QUALITY MANAGEMENT
II. PERSONNEL
III. BUILDINGS AND FACILITIES
IV. PROCESS EQUIPMENT
V. DOCUMENTATION AND RECORDS
VI. MATERIALS MANAGEMENT
VII. PRODUCTION AND IN-PROCESS CONTROLS
VIII. PACKAGING AND IDENTIFICATION LABELING
IX. STORAGE AND DISTRIBUTION
X. LABORATORY CONTROLS
XI. VALIDATION
XII. CHANGE CONTROL
XIII. REJECTION AND RE-USE OF MATERIALS
XIV. COMPLAINTS AND RECALLS
XV. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)
XVI. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS,
AND RELABELLERS
ACCORDING TO WHO GMP and ICH Q7 GUIDELINES
(Essential points)