PDA Technical Report No. 54-3 (TR 54-3) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations:Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products (single user digital version)
- Published
- Nov 2013
- ISBN
- 9780939459629
- Pages
- 53
- PDA Item Number
- 43511
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- PDF Single user
- Member Price
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- Nonmember Price
- $325.00
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Provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products. These case studies were chosen by the technical report team, of this supplemental annex to PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, to illustrate the adaptability of quality risk management tools to help solve various problems, implement corrective actions, and keep processes in a state of control.
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Case Study 1: Control of Visible Particulates
- Case Study 2: Combination Pharmaceutical/Device Product (Viral Clearance)
- Case Study 3: Lyophilization Technical Transfer/Scale-up Risk Analysis
- Case Study 4: Melamine Contamination (Supply Chain)
- Conclusion
- References
- Additional Reading
Figures and Tables Index
About the Authors