Summary of the Revised EU GMP Chapters 3, 5 and 8
Revised Chapters 3, 5, and 8 of the EU GMP Guidelines for GMP have been published and will become effective on 1 March 2015. Chapter 5, Production, is substantially revised including additional detail on the prevention of cross-contamination, supply chain requirements and reporting of drug shortages. Chapter 8, Quality Defects and Product Recalls, is also substantially revised to address investigations into potential quality defects. Investigations of these events should include appropriately qualified staff and, where appropriate, cross-functional teams should be included in performance of these activities. For your convenience, both the current and revised chapters are provided with a brief highlight of the changes.
To view or download the new version of EU Chapter 3, click here
To view or download the new version of EU Chapter 5, click here
To view or download the new version of EU Chapter 8, click here
To view or download the Rx-360 Summary, click here
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