Technical Reports: Electronic

PDA Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations (single user digital version)

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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Format: PDF (1 file 571 KB)

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Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. General Principles on Quality Risk Management Application
  4. Implementation of the Quality Risk Management Process
  5. How to Use Quality Risk Management As An Enabler
  6. Conclusions
  7. References
  8. Figures and Tables Index

Date of Publication: March 2012
ISBN Number: 9780939459384
Format: PDF
Number of Pages: 61
Binding: