EU Commission issues new EU GMP Guide Chapter 6

Recommendation

26-28 October 2021

Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online

In early April 2014, the EU Commission has published a new chapter 6 Quality Control. The new chapter will become effective on 1 October 2014. The main reasons for the changes (as e.g. the insertion of a new chapter on transfer of analytical methods) were already subject of our news Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control).

The now published document comprises different additions. For instance, the following was added in 6.5. Good Quality Control Laboratory Practices: "laboratory equipment should not be routinely moved between high risk areas to avoid accidental cross-contamination. In particular, the microbiological laboratory should be arranged so as to minimize risk of cross-contamination."

According to 6.9 now all Out of Trend (OOT) and all Out of Specification (OOS) results have to be considered and need to undergo an investigation. Also, in 6.12. a new requirement asks for a sampling plan based on risk assessment. Further content supplements (in addition to others) deal with the subject of reference standards. The newly inserted text under 6.20 states "… their qualification and certification as such should be clearly stated and documented. Whenever compendial reference standards from an officially recognised source exist, these should preferably be used as primary reference standards unless fully justified (the use of secondary standards is permitted once their traceability to primary standards has been demonstrated and is documented). These compendial materials should be used".

The regulations with regard to "Technical Transfer of Testing Methods" starting with point 6.37 up to 6.41 are completely new.

All attendees of ECA courses and conferences can download a document comparison between the current chapter 6 and the new version in the ECA website members' area. In this comparison all changes and additions are marked. Otherwise please also see the new Chapter 6 Quality Control for more information.