WHO GMP Guidelines For Active Pharmaceutical Ingredients

TELUGU GMP
0

WHO Good Manufacturing Practices For Active Pharmaceutical Ingredients


Annex 2


WHO Good Manufacturing Practices Guidelines For Active Pharmaceutical Ingredients


Click on the any titles below for complete guidelines


TABLE OF CONTENTS



1. Introduction

    1.1 Objective

    1.2 Regulatory applicability

    1.3 Scope


2. Quality management

     2.1 Principles

     2.2 Responsibilities of the quality unit(s)

     2.3 Responsibility for production activities

     2.4 Internal audits (self-inspection)

     2.5 Product quality review


3. Personnel

     3.1 Personnel qualifications

     3.2 Personnel hygiene

     3.3 Consultants


4. Buildings and facilities

     4.1 Design and construction

     4.2 Utilities

     4.3 Water

     4.4 Containment

     4.5 Lighting

     4.6 Sewage and refuse

     4.7 Sanitation and maintenance


5. Process equipment

     5.1 Design and construction

     5.2 Equipment maintenance and cleaning

     5.3 Calibration

     5.4 Computerized systems


6. Documentation and records

     6.1 Documentation system and specifications

     6.2 Equipment cleaning and use record

     6.3 Records of raw materials, intermediates, API labelling and packaging materials

     6.4 Master production instructions (master production and control records)

     6.5 Batch production records (batch production and control records)

     6.6 Laboratory control records

     6.7 Batch production record review


7. Materials management

     7.1 General controls

     7.2 Receipt and quarantine

     7.3 Sampling and testing of incoming production materials

     7.4 Storage

     7.5 Re-evaluation


8. Production and in-process controls

     8.1 Production operations

     8.2 Time limits

     8.3 In-process sampling and controls

     8.4 Blending batches of intermediates or APIs

     8.5 Contamination control


9. Packaging and identification labelling of APIs and intermediates

     9.1 General

     9.2 Packaging materials

     9.3 Label issuance and control

     9.4 Packaging and labelling operations


10. Storage and distribution

     10.1 Warehousing procedures

     10.2 Distribution procedures


11. Laboratory controls

    11.1 General controls

    11.2 Testing of intermediates and APIs

    11.3 Validation of analytical procedures

    11.4 Certificates of analysis

    11.5 Stability monitoring of APIs

    11.6 Expiry and retest dating

    11.7 Reserve/retention samples


12. Validation

    12.1 Validation policy

    12.2 Validation documentation

    12.3 Qualification

    12.4 Approaches to process validation

    12.5 Process validation programme

    12.6 Periodic review of validated systems

    12.7 Cleaning validation

    12.8 Validation of analytical methods


13. Change control


14. Rejection and reuse of materials

    14.1 Rejection

    14.2 Reprocessing

    14.3 Reworking

    14.4 Recovery of materials and solvents

    14.5 Returns


15. Complaints and recalls


16. Contract manufacturers (including laboratories)


17. Agents, brokers, traders, distributors, repackers and relabellers

    17.1 Applicability

    17.2 Traceability of distributed APIs and intermediates

    17.3 Quality management

    17.4 Repackaging, relabelling and holding of APIs and intermediates

    17.5 Stability

    17.6 Transfer of information

    17.7 Handling of complaints and recalls

    17.8 Handling of returns


18. Specific guidance for APIs manufactured by cell culture/fermentation

    18.1 General

    18.2 Cell bank maintenance and record keeping

    18.3 Cell culture/fermentation

    18.4 Harvesting, isolation and purification

    18.5 Viral removal/inactivation steps


19. APIs for use in clinical trials

    19.1 General

    19.2 Quality

    19.3 Equipment and facilities

    19.4 Control of raw materials

    19.5 Production

    19.6 Validation

    19.7 Changes

    19.8 Laboratory controls

    19.9 Documentation


20. Glossary


References


Appendix 1


List of references for related WHO guidelines


Appendix 2


General notes: additional clarifications and explanations



WHO Good Manufacturing Practices For Active Pharmaceutical Ingredient


Post a Comment

0Comments

New comments are not allowed.*