PIC/S Guide to GMP for medicinal products – version 16

The Guide is divided into two parts with 20 annexes. 

• Guide to Good Manufacturing Practice for Medicinal Products - Introduction
• Guide to Good Manufacturing Practice for Medicinal Products - Part I

Part I covers GMP principles for the manufacture of medicinal products

• Guide to Good Manufacturing Practice for Medicinal Products - Part II

Part II covers GMP for active substances used as starting materials

• Guide to Good Manufacturing Practice for Medicinal Products - Annexes

The annexes provide detail on specific areas of activity. For some manufacturing processes, different annexes will apply simultaneously.

• Technical interpretation of PIC/S GMP guide Annex 1 - Manufacture of sterile medicinal products

Guide to Good Manufacturing Practice for Medicinal Products - Introduction

1 February 2022

Contents

• Introduction
• Adoption and entry into force
• Revision history

Guide to Good Manufacturing Practice for Medicinal Products - Part I

1 February 2022

Contents

1. Pharmaceutical Quality System
2. Personnel
3. Premises and equipment
4. Documentation
5. Production
6. Quality control
7. Outsourced activities
8. Complaints and product recall
9. Self inspection

Guide to Good Manufacturing Practice for Medicinal Products - Part II

1 February 2022

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

Guide to Good Manufacturing Practice for Medicinal Products - Annexes

1 February 2022

Contents

• Annex 1 - Manufacture of sterile medicinal products
• Annex 2A - Manufacture of advanced therapy medicinal products for human use
• Annex 2B - Manufacture of biological medicinal substances and products for human use
• Annex 3 - Manufacture of radiopharmaceuticals
• Annex 4 - Manufacture of veterinary medicinal products other than immunologicals [This Annex is not adopted by the TGA]
• Annex 5 - Manufacture of immunological veterinary medical products [This Annex is not adopted by the TGA]
• Annex 6 - Manufacture of medicinal gases
• Annex 7 - Manufacture of herbal medicinal products
• Annex 8 - Sampling of starting and packaging materials
• Annex 9 - Manufacture of liquids, creams and ointments
• Annex 10 - Manufacture of pressurised metered dose aerosol preparations for inhalation
• Annex 11 - Computerised systems
• Annex 12 - Use of ionising radiation in the manufacture of medicinal products
• Annex 13 - Manufacture of investigational medicinal products
• Annex 14 - Manufacture of products derived from human blood or human plasma [This Annex is not adopted by the TGA]
• Annex 15 - Qualification and validation
• Annex 16 – Authorised person and batch release.
• Annex 17 - Real time release testing and parametric release
• Annex 18 - GMP guide for active pharmaceutical ingredients [This Annex no longer exists]
• Annex 19 - Reference and retention samples
• Annex 20 - Quality risk management
• Glossary

Feedback 

We welcome feedback that helps processes be improved. Any feedback regarding these changes or their implementation may be given to the TGA via the email gmp@health.gov.au. Any feedback will be used to improve inspection procedures and training.