Revision of Chapter 6 of the EU GMP Guide Quality Control - New Concept Paper

The EMA proposes the following changes:

“During inspections, GMP inspectors have noted that the root causes for suspected out-of-specification (OOS) results are sometimes attributed to a lack of test method validation in the context of transfer of analytical methods. Such situations also occur frequently at contract Quality Control laboratories.

In the context of globalisation of manufacturing activities and the development of new concepts like Quality by Design, where technology transfer is expected to happen worldwide both within and between companies, within the same country as well as between countries, the need for guidance for transfer of analytical methods has been identified.

The revision process for Chapter 6 will also assess the need to take into consideration:

  • the current guidance in Annexes 16, 19 and 20,
  • the ICH Q8, Q9, Q10 documents,
  • the draft document ICH Q11,
  • the ongoing revision of Chapters 4, 7 and Annex 11,
  • the development of new technologies such as Near Infrared Spectroscopy (NIR) in the context of raw material identification and Process Analytical Technology (PAT).

The need to provide specific guidance for endotoxin and microbiological testing will also be considered”.

Please also see the complete concept paper on the revision of chapter 6.

A few days ago ECA's new Analytical Quality Control Working Group has been established. Please refer to our GMP News dated 17 November 2010 for further details.

Part of the goals and objectives of this new working group are the provision of a European wide networking platform for Analytical Chemists and Scientists working and managing in a Quality Control environment and the promotion of active discussion of the latest regulatory requirements for QC within the European Union and US.

As one of the first projects the new working group will concentrate on developing a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. To manage this project the steering committee is looking for ECA members interested in getting actively involved to set up a review team. Please click here for further project information.

Dr Günter Brendelberger
On behalf of the European Compliance Academy

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