PIC/S GMP Guide Part - II for APIs


PIC/S GMP Guide Part II Basic Requirements for Active Pharmaceutical Ingredients: 

PIC/S GMP Guide Part II for APIs, INTRODUCTION 1.1 Objective: This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

Click the titles below for complete guidelines

Table of Contents

1. Introduction

2. Quality management

3. Personnel

4. Buildings and facilities

5. Process equipment

6. Documentation and records

7. Materials management

8. Production and in-process controls

9. Packaging and identification labelling of APIs and intermediates

10. Storage and distribution

11. Laboratory controls

12. Validation

13. Change control

14. Rejection and re-use of materials

15. Complaints and recalls

16. Contract manufacturers (including laboratories)

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

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

19. APIs for use in clinical trials

20. Glossary

PIC/S GMP Guide Part - II for APIs

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