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Publication of HMPC Documents on Essential Oils

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Publication of HMPC Documents on Essential Oils
Essential oils used as API in herbal products lead to – from a regulatory view – a wide range of questions. At the moment, there is no EMA/HMPC Guideline. Now, the final “Reflection Paper” has been published. Moreover, current questions and answers about essential oils have been added to a Q&A document. Read more in the News.

 

read at

http://www.gmp-compliance.org/enews_4303_Publication%20of%20HMPC%20Documents%20on%20Essential%20Oils_8483,8430,8369,Z-QCM_n.html

 

Publication of HMPC Documents on Essential Oils

At the beginning of May 2014, the EMA’s HMPC (Committee on Herbal Medicinal Products) published the final “Reflection Paper” on quality of essential oils used for the manufacture of herbal medicinal products/traditional herbal medicinal products. The document was adopted on 25 March by the HMPC.

This “Reflection Paper” should help consider aspects related to the nature and the specific production processes of essential oils.
Products with essential oils belong to herbal preparations. So far, the requirements on essential oils hadn’t been sufficiently addressed in the existing guidelines.

Moreover, the current HMPC quality guidelines don’t take into consideration the definitions of essential oils as laid down in the European Pharmacopoeia (Ph. Eur.).

Essential oils used as API in herbal products lead to – from a regulatory view – a wide range of questions, especially as the current guidelines incompletely depict the specific aspects of essentials oils.

In addition, a Q&A document containing questions and answers on herbal medicinal products/traditional herbal medicinal products was published on 30 April 2014. Four new questions and answers about essential oils have been added to this Q&A document.

For more detailed information please see the complete “Reflection paper on quality of essential oils as active substances in herbal medicinal products/taditional herbal medicinal products” as well as the extended Q&A document “Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products

 


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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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