BethAri Limited

Innovative Solutions, Delivered.

EU Commission issues new EU GMP Guide Chapter 6 - 23 Apr 2014

The EU commission in April 2014 issued the new chapter on Quality Control of the EU GMP which becomes effective on 1 October 2014.  One of the main reasons for the updates includes the insertion of a new chapter on transfer of analytical methods; and the addition in chapter 6.5, Good Quality Control Laboratory Practices the statement “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”.

Furthermore, the GMP guide now stipulates in Chapter 6.9 that all Out of Trend (OOT) and all Out of Specification (OOS) results have to be investigated.  In addition, in 6.12, a new requirement requests the sampling plan based on risk assessment.  Other inclusions address the subject of reference standards which stipulates in 6.20 "… 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 from chapter 6.37 up to 6.41 are totally new.

The revised document can be found by following the link –

< Back to News page