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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

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 AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 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, 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 32 PLUS year tenure till date Feb 2023, 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 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, 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 38 lakh plus views on New Drug Approvals Blog in 227 countries......https://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 He has total of 32 International and Indian awards

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Variations: How to submit Results of Confirmatory Stability Studies


 

Variations: How to submit Results of Confirmatory Stability Studies

The Co-ordination Group for Mutual Recognition and Decentralised Procedures has revised the Q/A-List for the Submission of Variations adding a question and answer regarding the submission of the results of confirmatory stability studies on production-scale batches. Read more.

 

read at

http://www.gmp-compliance.org/enews_4313_Variations%3A%20How%20to%20submit%20Results%20of%20Confirmatory%20Stability%20Studies_8358,Z-RAM_n.html

Variations: How to submit Results of Confirmatory Stability Studies

As a part of the Heads of Medicines Agencies, the CMD(h) (Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human) is publishing a number of interesting documents. Best Practice Guides questions-and-answer documents give valuable information regarding the point of view of the European registration and supervisory authorities. Now, the Q/A-List for the Submission of Variations has been updated.

Question 2.13 is dealing with the submission of the results of confirmatory stability studies on production-scale batches where stability data for pilot-scale batches have already been accepted during application for a MA.

The answer is:
It is not generally foreseen that these data are submitted to NCAs, either via variation or simple notification. It is the responsibility of the applicant to perform these studies as agreed. However in cases where issues arise during the confirmatory studies with production-scale batches (e.g. unexpected impurities, trends towards out of specification results etc.), the MAH should either submit a variation, if appropriate, (e.g. to correct the shelf-life, storage conditions etc.) or contact the RMS who will then decide whether any corrective action has to be taken.”

Here you can find the document with tracked changes.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, CMD(h), has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The CMD(h) has started its activities in November 2005 and replaced the informal Mutual Recognition Facilitation Group, which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.