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EU GMP Chapter 6, Quality Control, final version published

Revision of EU GMP Chapter 6 - Quality Control

The final version of a revised Chapter 6 was published in late March 2014 and becomes effective from 1 October 2014. The final version is almost identical to the draft revision that was published on 17 January 2013. This revision adds more emphasis on the need to investigate Out Of Specification (OOS) and Out Of Trend (OOT) results. The need for a procedure for OOS/OOT results is added to the documentation section and the requirement that “Any out of trend or out of specification data should be addressed and subject to investigation” is added.

The principal changes introduced by this revision are around requirements for test method validation and transfer. The need to verify test methods that were not originally validated by the laboratory using them has been added, as has the requirement for reference standards to be certified, qualified and verified as suitable for the intended use.

A whole new section on “Technical transfer of testing methods” has been added. This requires that a method transfer protocol be written and approved. This protocol should include the following parameters:

• Identification of the relevant test method(s) undergoing transfer
• Identification of the additional training requirements
• Identification of standards and samples to be tested by both laboratories
• Identification of any special transport and storage conditions of test items
• Identification of the testing to be performed
• The acceptance criteria which should be based upon the current validation study of the methodology and with respect to ICH/VICH requirements

Where appropriate, specific requirements described in other European Guidelines, should be addressed for the transfer of particular testing methods (e.g. Near Infrared Spectroscopy).

There are other new requirements given in this revision:

• Reference standards should be certified, qualified and verified as suitable for their intended use. Where a compendial reference standard from an officially recognised source exists it should be used as the primary standard. Secondary standards can be used once their traceability to primary standards has been demonstrated and documented.
• Culture media should be prepared in accordance with the manufacturer’s requirements unless scientifically justified. The performance of all culture media should be verified prior to use
• Microbiological media and strains should be decontaminated and disposed of in a manner to prevent the cross-contamination and retention of residues. The in-use shelf life of microbiological media should be established, documented and scientifically justified
• The expectations for the control of animals used in testing have also been added (these were not in the 2013 draft revision)