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PDA TR 54

Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations

Report / Survey by Parenteral Drug Association , 03/01/2012

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Full Description

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.
 

Product Details

Published:
03/01/2012
ISBN(s):
9780939459384
Number of Pages:
61
File Size:
1 file , 760 KB
Product Code(s):
01054