Investigational Pharmaceutical For Clinical Trials in Humans

WHO Good Manufacturing Practices: Supplementary Guidelines For The Manufacture Of Investigational Pharmaceutical Products For Clinical Trials in Humans, WHO TRS 863, 1996 Annex 7

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TABLE OF CONTENTS

1. Introductory Note

2. General Considerations

3. Glossary

4. Quality Assurance

5. Validation

6. Complaints

7. Recalls

8. Personnel

9. Premises and Equipment

10. Materials

11. Documentation

12. Production

13. Quality Control

14. Shipping, Returns, and Destruction

References

Investigational Pharmaceutical For Clinical Trials in Humans