Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control

On 17 January 2013, the EU Commission published the draft of the revised Chapter 6 Quality Control of the EU GMP Guide. The reason for the change was the inclusion of a new section on technical transfer of testing methods and other items such as out of specification (OOS) results.

With regard to the new requirements on the transfer of analytical methods Chapter 6 states that

• the transferring site should verify that the test methods comply with those as described in the Marketing Authorisation,
• the original validation of the test methods should be reviewed to ensure compliance with current ICH requirements,
• A gap analysis should be performed to identify any supplementary validation needed that should be performed prior to beginning the method transfer,
• the transfer should be described in a written protocol.

This protocol should include the relevant test methods, the additional training requirements, standards and samples to be tested by both laboratories, and any special transport and storage conditions of test items.

The acceptance criteria for the method transfer should be based on the current validation study of the methodology. Deviations from the protocol have to be investigated prior to closure of the technical transfer process. The technical transfer report should document the comparative outcome of the process and should identify areas requiring further test method revalidation, if applicable.

Please also see the revised Chapter 6: "Quality Control" of the EU GMP Guide.

Deadline for comments is 18 July 2013.

Further information about the actual requirements for method transfer can also be found at the WHO Guideline on Transfer of Technology in Pharmaceutical Manufacturing, especially Chapter 6, Quality Control: Analytical Method Transfer. Here you can find possible experimental designs and acceptance criteria for the main analytical testing methods.