PDA TR 54 PDF

PDA TR 54 PDF

Name:
PDA TR 54 PDF

Published Date:
03/01/2012

Status:
Active

Description:

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

Publisher:
Parenteral Drug Association

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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Choose Document Language:
$97.5
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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.
File Size : 1 file , 760 KB
ISBN(s) : 9780939459384
Number of Pages : 61
Product Code(s) : 01054
Published : 03/01/2012

History


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