WHO Guidelines for drafting a site master file | Annex 14

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TABLE OF CONTENTS

1. Introduction

2. Purpose

3. Scope

4. Content of site master file

Appendix - Content of a site master file

1. General information on the manufacturer

1.1 Contact information on the manufacturer

1.2 Authorized pharmaceutical manufacturing activities of the site

1.3 Any other manufacturing activities carried out on the site

2. Quality management

2.1 The quality management system of the manufacturer

2.2 Release procedure of finished products

2.3 Management of suppliers and contractors

2.4 Quality risk management

2.5 Product quality reviews

3. Personnel

4. Premises and equipment

4.1 Premises

4.2 Equipment

5. Documentation

6. Production

7. Quality control

8. Distribution, complaints, product defects and recalls

9. Self-inspections

WHO Guidelines for drafting a site master file/Annex 14: