Mahendra Chemicals gets FDA Warning Letter with Focus on “Data Integrity”

A Warning Letter issued by the US Food & Drug Administration (FDA) to an Indian API manufacturer on 13 July 2015 shows again a clear focus on the missing integrity of data. Specifically, the following issues are addressed:

1. Activities were not recorded at the time they were carried out and original data were deleted:

Entries in the manufacturing protocols were made only days after the relevant activities had been conducted. Further, batches were released before all results were available.

In particular the use of “rough notes” was criticised as these original data were completely destroyed after transfer in the batch records.

2. Due to unauthorised access to data systems, data could be modified or deleted:

Specifically HPLC, GC, and Karl Fischer Titrators were concerned. For instance, for the GC instrument multiple copies of raw data were found in the waste. And there was no password regulation for the data systems of HPLC and GC equipment, and there were no audit trail functions either.

3. There were no training protocols for the cGMP training of employees.

Altogether there were great concerns about the authenticity and reliability of the data produced in this company. Thus the FDA requested a comprehensive CAPA plan within 15 working days upon receipt of the Warning Letter.

For detailed information please see the full Mahendra Chemicals Warning Letter.

Source: FDA, United States

http://www.gmp-compliance.org/enews_04979_Another-FDA-Warning-Letter-with-Focus-on-%22Data-Integrity%22_200028,9363,Z-QCM_n.html

 

      1. Map of Mahendra Chemicals
        Mahendra Chemicals 

Address: B-1, 217/218/2, Phase 2, G I D C Estate, Naroda, Naroda, Ahmedabad, Gujarat 382330

//////////FDA,  Warning Letter, Data Integrity, Mahendra Chemicals

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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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