Electronic PDA Technical Reports

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)

PDA's Technical Report No. 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems provides practical guidance on how to manage quality risks throughout the manufacturing system lifecycle and illustrates concepts through two case studies.

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:

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  1. Introduction
  2. Glossary and Abbreviations
  3. Quality Risk Management Best Practices
  4. Quality Risk Management Applications for Strategic Planning and Project Initiation
  5. Defining Requirements
  6. Manufacturing System Design
  7. Quality Risk Management Application for Commisioning and Qualification
  8. Quality Risk Management in Quality Systems
  9. Tools and Templates
  10. Conclusion
  11. References
  12. Additional Reading
  13. Appendix 1: Case Study 1
  14. Appendix 2: Case Study 2

Figures and Tables Index


Date of Publication: May 2017
ISBN Number: 9780939459964
Format: PDF
Number of Pages: 107
Binding: