GMP

GMP

What is GMP?

Good manufacturing practice (GMP) comprises that part of quality assurance aimed at ensuring that a product is consistently manufactured to a quality appropriated to its intended use.

GMP requires that the manufacturing process is fully defined before it is initiated and that all necessary facilities are provided. In practice, this means that personnel must be adequately trained, suitable premises and equipment used, correct materials used, approved procedures adopted, suitable and transport facilities available and appropriate records made.

Why it is required?

The Good Manufacturing Practices are prescribed to ensure that: i. Raw materials used in the manufacture of pharmaceuticals are authentic, of prescribed quality and are free from contamination. ii. The manufacturing process is as has been prescribed to maintain the standards. iii. Adequate quality control measures are adopted and iv. The manufactured drug which is released for sale has the prescribed quality. v. To achieve the objectives listed above, each licencee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, teaching institutions and registered qualified Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not selling such drugs in the market are exempted from the purview of G.M.P.

WORLD HEALTH ORGANIZATION (WHO) GMP

WHO defines good manufacturing practice has "that part of quality assurance which assures that products are consistently produced and controlled to the quality standards appropriate to their indented use and as required by the marketing authorization"

GMP covers all aspects of the manufacturing process: defined manufacturing processes; critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures have been taken; full traceability of a product through batch rewards and distribution records and systems for recall and investigation of complaints.

GMP REQUIREMENTS FOR PREMISES AND MATERIALS FOR PHARMACEUTICAL PRODUCTS

1. GENERAL REQUIREMENTS
1.1. Location and surroundings.-

1.2. Buildings and premises.–

1.3. 1.3 Water system

1.4. 1.4 Disposal of waste

2. WAREHOUSING AREA

3. PRODUCTION AREA

4. ANCILLARY AREAS

5. QUALITY CONTROL AREA

6. 6. PERSONNEL

7. 7. HEALTH, CLOTHING AND SANITATION OF WORKERS

8. MANUFACTURING OPERATIONS AND CONTROLS

9. 9. SANITATION IN THE MANUFACTURING PREMISES

10. 10. RAW MATERIALS

11. 11. EQUIPMENT

12. 12. DOCUMENTATION AND RECORDS

13. LABELS AND OTHER PRINTED MATERIALS

14. QUALITY ASSURANCE

15. SELF INSPECTION AND QUALITY AUDIT

16. QUALITY CONTROL SYSTEM

17. SPECIFICATION

17. 1. For Raw materials and Packaging materials:

17. 2. For Product Containers and Closures –

17. 3. For in-process and bulk products—

17. 4. For Finished Products –

17.5 For preparation of containers and closures. –

18. MASTER FORMULA RECORDS

19. PACKAGING RECORDS

20. BATCH PACKAGING RECORDS

21. BATCH PROCESSING RECORDS

22. STANDARD OPERATING PROCEDURES (SOPS) AND RECORDS, REGARDING
22. 1. Receipt of Materials;

22. 2. Sampling

22. 3. Batch Numbering –

22. 4. Testing

22. 5. Records of analysis.-

23. REFERENCE SAMPLES

24. REPROCESSING AND RECOVERIES

25. DISTRIBUTION RECORDS

26. VALIDATIONS AND PROCESS VALIDATION

27. PRODUCT RECALLS

28. COMPLAINTS AND ADVERSE REACTIONS

29. SITE MASTER FILE

29. 1. General information.-

29. 2. Personnel –

29. 3. Premises –

29. 4. Equipment –

29. 5. Sanitation –

29. 6. Documentation –

29. 7. Production –

29. 8. Quality control –

29. 9. Loan license manufacture and licensee –

29. 10. Distribution, complaints and product recall –

29. 11. Self-Inspection –

29.12. Export of drugs –