What are the GMP Responsibilities of the Marketing Authorisation Holders?

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The European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH).

http://www.gmp-compliance.org/enews_05618_What-are-the-GMP-Responsibilities-of-the-Marketing-Authorisation-Holders_15367,15360,15355,15618,Z-QAMPP_n.html

The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH). It is not intended to introduce any new responsibilities on MAHs but to document existing requirements in a better way.

The current EU GMP-Guidelines define in several chapters and annexes GMP tasks and responsibilities of the MAH. However, there seems to be a lack of clarity and understanding as to what these responsibilities actually are in their totality, and what they mean for MAHs at a practical level. All these tasks and responsibilities have now been summarised in this concept paper:

  • Chapter 1: responsibility to evaluate the results of the PQR review
  • Chapter 7: responsibility to put contracts in place
  • Chapter 8: responsibilities concerning quality defects, risk-reducing actions and notification of possible disruption in supply
  • Annex 2: responsibility to put contracts in place
  • Annex 12: obligations to approve the design of irradiation cycles, and agreeing the location for retention of irradiation cycle records.
  • Annex 16: requirement to identify the site and QP responsible for certifying each batch (in the case of multiple sites authorised to manufacture / import / certify the same product) and the statement that the “ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy” lies with the MAH
  • Annex 19: responsibilities for ensuring that reference and retention samples are taken, and stored.

The GMP/GDP Inspectors Working Group thinks that the issues outlined above “are not without important consequences. The way in which MAHs are expected to interact with the manufacturing sites registered in a marketing authorisation is not sufficiently clear, given the diverse ways in which the various MAH responsibilities are set out in the EC Guide to GMP, and differing (often complex) supply chains.”

So what is next?

According to the Concept Paper, “It is recommended that the GMP/GDP Inspectors Working Group (GMP/GDP IWG) should produce a reflection paper intended for Part III of the EU GMP Guide or in another appropriate location (e.g. as proposed by the GMP/GDP IWG). This would capture all of the responsibilities that apply to MAH companies to enable manufacturers to comply with GMP. It would also result in a more complete picture of the regulatory environment with respect to GMP in which the MAH operates.”

The deadline for comments on the concept paper is end of November 2016. Comments should be sent to adm-gmdp@ema.europa.eu.

////////GMP Responsibilities,  Marketing Authorisation Holders

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Author: DR ANTHONY MELVIN CRASTO Ph.D

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 amcrasto@gmail.com, 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......http://newdrugapprovals.wordpress.com/ , 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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