
Equipment Qualification in the Pharmaceutical Industry
Description
Key Features
- Incorporates good manufacturing processes into a compliant qualification program
- Provides examples of protocol layout
- Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements
Readership
Table of Contents
1. Introduction
2. Documentation - Getting Ready
3. Quality Systems
4. Equipment Design Considerations
5. Equipment Controls and Automation
6. Preparing the Protocols - General Approach
7. Commissioning & Decommissioning
8. Equipment Qualification Protocols
9. Equipment Checklist
10. Protocol Execution
11. Protocol ReportsAppendix
A. Definitions
B. Examples
C. References
Product details
- No. of pages: 234
- Language: English
- Copyright: © Academic Press 2019
- Published: June 13, 2019
- Imprint: Academic Press
- Paperback ISBN: 9780128175682
- eBook ISBN: 9780128175699
About the Author
Steven Ostrove
Affiliations and Expertise
Ratings and Reviews
Latest reviews
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StevenOstrove Mon Jan 27 2020
Equipment Qualification in the Pharmaceutical
Equipment Qualification in the Pharmaceutical Industry