FDA publishes new GMP Guide for Cosmetic Products

 

FDA publishes new GMP Guide for Cosmetic Products

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. Please read more here.

http://www.gmp-compliance.org/ecanl_621_0_news_3776_n.html

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. This new draft Guideline includes recommendations on documentation, recordkeeping, buildings and facilities, equipment, raw materials, production, internal audits, laboratory controls, handling of complaints and reports of adverse events as well as on conducting recalls.

The new guidance document revises the existing “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topic areas based on recent experience. In addition the FDA intends to harmonize their own requirments with those published by the International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007). However, FDA has only incorporated elements of ISO 22716, as appropriate, and consistent with FDA regulations. Some ISO requirements have not been transfered to the new FDA Guide. But also some additional requirements not included in the ISO 22716 have been incorporated in the guide. The Guide also refers to a Guidance for Industry on Cosmetics Processors and Transporters of Cosmetics Security Preventive Measures which was already revised in October 2007. Different to most other FDA Guidance documents this Guidance for Industry is also available in Dutch, German, French, Arabic, Korean, Thai as well as in Chinese language.

Reference:  June 2013 revision of the Guidance for Industry: Cosmetic Good Manufacturing Practices

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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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