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

Published: Jun 2013
ISBN: 9780939459551
Pages: 63
PDA Item Number: 43504

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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.

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Introduction
Glossary of Terms
Case Study 1: Control of Liquid Drug Product During Packaging
Case Study 2: Risks Associated with Secondary Packaging Components Production
Case Study 3: Control of Logistics Channels for Liquid Product in Bulk Hold Pending Packaging
Case Study 4: Risks in Packaging, Handling and Transport of Liquid Filled Glass Syringe
Case Study 5: Control of Logistics Channels for Refrigerated Bulk Solid Oral Dose
Conclusion
Additional Reading
References

Figures and Tables Index