Good Manufacturing Practices (GMP) are essential for ensuring the quality and safety of drugs, with regulations established to guide manufacturers in maintaining high standards. Key principles of GMP include quality assurance, sanitation, personnel training, and systematic processes aimed at continuous improvement. Compliance with GMP is mandatory in regulated pharmaceutical markets and is crucial for effective quality management throughout the production lifecycle.

2. Good Manufacturing Practices
Purpose and Principles of GMP
DIPSAR
MD. IMRAN MALIK
(D.pharm, B.pharm- DIPSAR)
Persuing M.Pharm (Pharm. Management)
New Delhi, 14 Aug, 2015
2

3. GOOD MANUFACTURING PRACTICES
QUALITY OF DRUGS IS ESSENTIALLY THE RESPONSIBILITY OF
MANUFACTURERS.
GMP GUIDELINES ARE A MEANS TO ASSURE THIS VERY QUALITY OF
DRUGS.
GMP REGULATIONS WERE INTRODUCED IN THE FORM OF AMENDED
SCHEDULE ‘M’ IN 1988.

4. PRINCIPLES OF GMP
 1. General Requirements
Location and surrounding
Buildings and premises
Water system
Disposal of waste
 2. Quality assurance (QA)
 3. Sanitation and hygiene
 4. Qualification and validation

5.  5. Warehousing area
 6. Production area
 7. Ancillary areas
 8. Quality control area
 9. Personnel
 10. Quality control area
 11. Manufacturing operations and control

6.  12. Raw materials
 13. Documentation and records
 14. Self inspection and quality audit
 15. Specifications
 16. Master formula records
 17. Standard Operating Procedures (SOP)

7. GMP is actually Good Common Sense
Quality Management
Quality Assurance
GMP
Production and Quality Control

8. Quality Management:
What is Quality Management?
The aspect of management function that determines and
implements the “quality policy”
The overall intention and direction regarding quality, as
formally expressed and authorized by top management

9. Intermezzo: the five P's
 Premises
 Primary materials
 People
 Procedures
 Processes defined and recorded

10. Quality Assurance
 QUALITY ASSURANCE IS COMPANY BASED.
 Quality assurance is a management tool
 In contractual situations, it also serves to generate confidence in
a supplier
 QA, GMP and Quality Control are interrelated aspects of Quality
Management

11. The position of QA
DirectorDirector
QAQA
ProductionProduction QC labQC lab Other DeptsOther Depts

12. Quality Assurance includes:
 Responsibility of the Manufacturer for the quality of the product
Fit for intended use
Comply with marketing authorization
Safety, efficacy and quality
 Commitment of senior management and involvement of all staff
 Comprehensively designed and well implemented quality system
 Full documentation and monitoring of effectiveness
 Competent personnel, sufficient premises, equipment and facilities

13. AIM OF Good Manufacturing Practices
 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)

14. Basic requirements for GMP:
 Clearly defined and systematically reviewed processes
 Qualification and validation is performed
 Appropriate resources are provided:
Qualified and trained personnel
Premises, space, equipment and services
Materials, containers, labels
Procedures, storage, transport
Laboratories and in-process control

15.  Clear, written instructions and procedures
 Trained operators
 Records of actions, deviations and investigations
 Records for manufacture and distribution
 Proper storage and distribution
 Systems for complaints and recalls

16. GMP = continuous urge for improvement
 Involvement of the management
 Annual Product Quality Review
 Complaints handling
 Self-inspection

17. Annual Product Quality Review
Objectives to do an Annual Product Quality Review:
 To review and verify the consistency and appropriateness of the
existing process
 To identify and highlight any trends in the process, e.g. in analytical
results, yields etc.
 To identify any possible product or process improvements

18. Complaints handling
“All complaints and other information concerning
potentially defective products must be carefully
reviewed according to written procedures and
corrective action should be taken.”
 Investigation and evaluation should result in
appropriate follow-up actions
 All decisions and measures taken should be recorded
 Referenced in batch records
 Records reviewed - trends and recurring problems

19. Self-Inspection
Purpose is to evaluate whether a company’s operations
remain compliant with GMP
 The programme should
cover all aspects of production and quality control
be designed to detect shortcomings in the implementation of GMP
recommend corrective actions
set a timetable for corrective action to be completed
 Be performed routinely
 Also on special occasions such as
Recalls
Repeated rejections
When a GMP inspection is announced by the national drug
regulatory authority

20. Summary and conclusions:
 GMP is mandatory in countries with a regulated pharmaceutical
market, and in the WHO Prequalification Programme too.
 GMP's are very similar, they are nothing but Good Common Sense
 Good Practices cover all aspects of company's activities prior to sales
 GMP is not a reward, nor an external assignment, it should be built
into the company
 Just like quality, which should be built into the product
 The role and involvement of senior management is crucial
 GMP means an urge for continuous improvement, 3 of the tools to do
so are:
Annual Product Quality Reviews
Complaint handling and trending
Self-inspection

21. THANK
YOU