The document discusses ICH Q7, a guideline for good manufacturing practices for active pharmaceutical ingredients. It aims to improve quality, enhance productivity and effectiveness of API manufacturing. ICH Q7 applies to APIs made through chemical synthesis, extraction, fermentation or combinations and establishes requirements for quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging and more. Adherence to ICH Q7 helps ensure APIs are safe, effective and of good quality and prepared according to cGMP standards expected by regulatory agencies like the FDA.

1. ICH Q7 GUIDELINE
Submitted To
Prof. Elaine L. Pratt
By
PRASHANT BHARADVA
Term Paper Presentation
on

2. ICH Q7
GOOD MANUFACTURING GUIDES FOR ACTIVE
PHARMACEUTICAL INGREDIENTS
 Objectives
 Gain knowledge of GMP for Active Pharmaceutical Ingredients
 Improve quality and output of API manufacturing processes.
 Enhance productivity and effectiveness of API manufacturing.
 Enhance awareness during regulatory inspections.
 Scope
 Applies to all APIs manufactured by chemical synthesis,
extraction, fermentation, recovery from natural source or
combination of these processes
 Does not apply to sterilization and aseptic processing of the API
 Does not cover all the vaccines, whole blood or plasma, whole
cells and gene therapy APIs

3. ICH Q7 - SUBPARTS
11. Laboratory Controls
12. Validation
13. Change Control
14. Rejection and Re-use of the
Materials
15. Complaints and Recalls
16. Contract Manufacturers
17. Agents, Brokers, Traders,
Distributors, Repackers and
Relabellers
18. Special Guidance for APIs
manufactured by Cell Culture/
Fermentation
19. APIs for use in Clinical Trials
1. Introduction
2. Quality Management
3. Personnel
4. Building and Facilities
5. Process Equipment
6. Documentation and Records
7. Materials Management
8. Production and In-process
Controls
9. Packaging and Identification
Labeling of APIs and
Intermediates
10. Storage and Distribution

4. HOW CLOSELY DOES THE FDA EXPECT THE
API MANUFACTURER TO ADHERE TO ICH Q7
FOR GMPS?
 ICH Q7 was developed by designated ICH Expert working
group, like its ICH Q1-Q11 siblings, which was subjected to
consultation by the regulatory parties
 Endorsed in November 2000 by the ICH Steering committee and
is consequently accepted by ICH regulatory bodies of Europe,
United States and Japan.
 In United States, cGMP guidelines for finished pharmaceuticals
are clear and mentioned by FDA in 21 CFR Part 210/211 but
what about cGMP for APIs? APIs still need to be manufactured
by cGMP.
 The answer is ICH Q7.
 It ensures that APIs manufactured by following it are safe,
effective and of good quality.
 Therefore, closely adhering to ICH Q7 ensures good quality of
API with no cGMP adulteration.

5. CONCLUSION
 ICH Q7 is very important in maintaining quality of the APIs.
 API manufacturer can improve output of the manufacturing
process
 Helps to enhance productivity as well as effectiveness of the
manufacturing process
 ICH Q7 ensures less batch to batch variations and less chances
of recalls.
 Following this guideline can also help during regulatory
inspections.