The PIC/S guide to GMP for medicinal products

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly known as PIC/S) developed international standards between countries and pharmaceutical inspection authorities, to provide a harmonised and constructive co-operation in the field of GMP.

The PIC/S provide an active and constructive cooperation in the field of GMP and related areas. The purpose of PIC/S is to facilitate:

• Networking between participating authorities
• Maintenance of mutual confidence
• Exchange of information and experience
• Mutual training of GMP inspectors.

The PIC/S guide to GMP for medicinal products

The PIC/S Guide to GMP for medicinal products applies to all medicines.

The Guide is divided into two parts and a number of annexes which are common to both parts.

Guide to Good Manufacturing Practice for Medicinal Products - Introduction

PICS GMP Gude (Intro) (picscheme.org)

Guide to Good Manufacturing Practice for Medicinal Products-Part I

[Part I covers GMP principles for the manufacture of medicinal products]

PICS GMP Guide Part I (picscheme.org)

Guide to Good Manufacturing Practice for Medicinal Products - Part II

[Part II covers GMP for active substances used as starting materials]

GMP Guide Part II APIs (picscheme.org)

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]

PICS GMP Guide (Annexes) (picscheme.org)

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

Guide to Good Manufacturing Practice for Medicinal Products Introduction:

Contents

• Introduction
• Adoption and entry into force
• Revision history

Guide to Good Manufacturing Practice for Medicinal Products - Part I

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

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

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
• Annex 5 - Manufacture of immunological veterinary medical products
• 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
• Annex 15 - Qualification and validation
• Annex 16 - Qualified person and batch release
• Annex 17 - Real time release testing and parametric release
• Annex 18 - GMP guide for active pharmaceutical ingredients
• Annex 19 - Reference and retention samples
• Annex 20 - Quality risk management
• Glossary

Technical interpretation of PIC/S GMP guide Annex 1 - Manufacture of sterile medicinal products 8 January 2010

PIC/S has published a recommendation for the technical interpretation of Annex 1 on the Manufacture of Sterile Medicinal Products.

Contents

• Document history
• Purpose and scope
• Basics
• Definitions and abbreviations
• New texts and their interpretation
• Revision history