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Amendment of Chapter 6 of GMP

Lucile Roger Durieux | 28 April 2014 |

Chapter 6 (Part 1) of GMP incorporates transfers of test methods

Amendment of Chapter 6 of GMP : Quality control of European Guide to come into effect in the autumn.

The European Commission has announced an amendment to Chapter 6 : Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1.

Transfer from one laboratory to another

The amendment consists of including a section concerning the technical transfer of test methods (and other factors, such as out-of-specification results). The new section includes, in particular, advice on transferring the protocol from one laboratory to another and on the transfer protocol (identification of the test to be performed, samples to be tested, etc.). It also completes the sections concerning good laboratory practice for quality control (documentation, sampling, stability monitoring programme, etc.).

The latest date for the entry into effect of this new version of the text is fixed at 1 October 2014.

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