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PDA TR 54-2 PDF

PDA TR 54-2 PDF

Name:
PDA TR 54-2 PDF

Published Date:
06/01/2013

Status:
Active

Description:

Technical Report No. 54-2 (TR 54-2) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling

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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$97.5
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The first Annex to Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides specific case studies on how to apply quality risk management (QRM) to pharmaceutical manufacturing, specifically packaging and labeling operations. This report is intended to align with ICH Q9 and is one in a series of similar documents that provide additional examples of how to apply risk management tools across the product supply chain. Technical Report No. 54-2 was drafted by an all-volunteer team of experts representing companies like Merck, Amgen and Genentech.
File Size : 1 file , 1.7 MB
ISBN(s) : 9780939459551
Number of Pages : 63
Product Code(s) : 01054-2
Published : 06/01/2013

History

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