PDA Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (single user digital version)
- Published
- May 2017
- ISBN
- 9780939459964
- Pages
- 107
- PDA Item Number
- 43533
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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The information in this technical report is applicable to both new and existing manufacturing systems used in clinical, commercial manufacturing, drug substance (API), drug product, packaging and warehousing and critical utility systems. It focuses on manufacturing systems, which can potentially impact product quality.
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Format: PDF (1 file 1.97 MB)
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary and Abbreviations
- Quality Risk Management Best Practices
- Quality Risk Management Applications for Strategic Planning and Project Initiation
- Defining Requirements
- Manufacturing System Design
- Quality Risk Management Application for Commisioning and Qualification
- Quality Risk Management in Quality Systems
- Tools and Templates
- Conclusion
- References
- Additional Reading
- Appendix 1: Case Study 1
- Appendix 2: Case Study 2
Figures and Tables Index