EU Commission issues new EU GMP Guide Chapter 6

EU Commission issues new EU GMP Guide Chapter 6
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. Read more in the GMP news to the new EU GMP chapter quality control.



EU Commission issues new EU GMP Guide Chapter 6

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.




DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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