Still a GMP problem? Or already a criminal act? Do we need more stringent measures and enforcement in certain situations?

Still a GMP problem? Or already a criminal act? Do we need more stringent measures and enforcement in certain situations?

Sometimes EU and FDA Inspectors discover serious GMP deviations and fraud during an inspection. What are the consequences and do we need to think about additional measures? Please read more in our GMP News.

http://www.gmp-compliance.org/enews_4467_Still-a-GMP-problem-Or-already-a-criminal-act-Do-we-need-more-stringent-measures-and-enforcement-in-certain-situations_8401,S-QSB_n.html

When GMP issues are discussed, different interpretations are possible. Sometimes, the implementation of GMP regulations and expectations can be a challenge. However, everyone involved should do his/her best to make sure that GMP has been put in place and that patient safety is ultimately guaranteed.

Now and again, companies may receive GMP Non-Compliance Statements from EU Inspectors or Warning Letters from US FDA Inspectors because of non-compliance issues identified during inspections. This is a serious situation for the companies involved. Organisational problems and frequently also gross mismanagement can be the reasons for these deviations. In most cases companies react professionally to such situations; they identify the underlying root cause and take corrective actions to avoid future problems.

But how to deal with situations where fraud is involved (e.g. Ranbaxy case)? Or when GMP deviations are so serious that they can no longer be just considered as an accidental mistake? Everyone in the GMP environment should be shocked when data have been faked or adulterated, or when not even basic GMP processes have been implemented. How to deal with these companies? Can we already talk about criminal acts?
For example, just a few days ago, the US FDA issued a Warning Letter and an import alert for Marck Biosciences Ltd in India. The content is repulsive and scandalous for the company. The Warning Letter states:  During the inspection, “investigators noted significant mold growth in the washroom located at the entry to the sterile manufacturing area. The ceiling of this room had been allowed to deteriorate to such an extent that it caved in. This room shares a common mezzanine with the adjacent sterile processing rooms.” Moreover, the company faked GMP records and released products to the market which could endanger patient safety. Staff members and management must have known for a long time about the situation. But instead of fixing the problem they neglected these obvious GMP deviations and even lied about the real situation by faking documents.

If FDA or EU Inspectors would identify such a similar issue on their own territory a criminal investigation would be the consequence. Especially when patient safety is at risk or when patients have already been hurt (e.g. Heparin case). But how to deal with companies which are located outside of their territory? Is an import stop still sufficient here? Maybe regulators should think about further actions to be taken against those companies and their management when a GMP deviation can no longer be considered as an accidental error but a criminal act. The information provider Regulatory Focus (RABS) already lists 12 companies in India where serious data integrity issues including faking of documents have been observed. Most of these cases can not be considered as a GMP problem but must be considered as a deliberate adulteration and falsification of data (fraud).

In our GMP News US Regulators may ask CEO to certify Compliance we wrote about additional actions which have been considered by the US Department of Justice to increase the pressure on companies and management. This might serve as the first step to better deal with situations where companies and management deliberately put patient safety at risk.

from the net……………..

 

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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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