Monday, 28 January 2013

EU GMP draft chapters produced

On 17 January 2013, the EU Commission published the drafts of 4 revised chapters of the EU GMP Guide, according to the ECA.

The changes relate to:
  • Chapter 3 ‘Premise and Equipment’. Paragraph 6 has been revised and extended. It contains regulations on how to avoid cross-contamination and the changes made are linked with the revised contents of Chapter 5 Production. See: Chapter 3
  • Chapter 5 ‘Production’. Changes have been made to paragraphs 17 to 20, also in relation to cross-contamination. In addition, paragraphs 26 to 28 on Qualification of Suppliers have also been modified. See: Chapter 5
  • Chapter 6 ‘Quality Control’. The chapter now provides new requirements on the transfer of analytical methods as well as new regulations about the handling of out-of-specification results.  See: Chapter 6
  • Chapter 8 outlines the importance of a quality management system for the evaluation of quality defects in relation to product recalls and likewise clarifies the requirements regarding the reporting (when and how) of quality defects to the authority.  See: Chapter 8
For further details and links to the drafts, please see the ECA website.

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