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GMP Case Study: Lessons from FDA 483s & Warning Letters

 

 


ICH API GMP

 

ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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 Manufactures (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

 

 

 

ICH Q7 Implementation Working Group - ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients: Questions & Answers

 


 

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