Sunday, 28 September 2014

EU Commission publishes revised EU GMP Guide Chapters 3 and 5

The EU Commission has revised versions of chapter 3 "Premises and Equipment" and 5 "Production". The new chapters are effective from 1 March 2015.

With chapter 3, the stated change is: “Reasons for changes: The only change is to section 6 as part of the improved guidance on prevention of cross-contamination involving also Chapter 5.”

With chapter 4, the stated change is: “Reasons for changes: Changes have been made to sections 17 to 21, including adding a new section, to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment. Changes were also introduced in sections 27 to 30, including adding a new section, on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Sections 35 and 36 are inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials while section 71 introduces guidance on notification of restrictions in supply.”

For chapter 3, see: Chapter 3
For chapter 4, see: Chapter 4

Posted by Tim Sandle

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