PDA Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations (single user digital version)
- Published
- Mar 2012
- ISBN
- 9780939459384
- Pages
- 61
- PDA Item Number
- 43493
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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PCMOSM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides detailed guidance for the application and implementation of quality risk management (QRM) principles throughout the product lifecycle. Intended to align with ICH Q9 and present information that can be helpful to the reader on how to implement QRM, the report emphasizes QRM application during commercial manufacturing and integrating QRM into the pharmaceutical quality system.
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents
- Introduction
- Glossary of Terms
- General Principles on Quality Risk Management Application
- Implementation of the Quality Risk Management Process
- How to Use Quality Risk Management As An Enabler
- Conclusions
- References
- Figures and Tables Index