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IMPs: How do GDP Guidelines apply?

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Is distribution of Investigational Medicinal Products covered by the new Guidelines on Good Distribution Practice (GDP)? What needs to be considered can be found here.

http://www.gmp-compliance.org/enews_4424_IMPs%3A%20%20How%20do%20GDP%20Guidelines%20apply%3F_8397,8527,9008,Z-PDM_n.html

 

GMP News: IMPs: How do GDP Guidelines apply?

The 2013 Guidelines on Good Distribution Practice (2013/C 343/01) apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines? The Guidelines focus on wholesale distribution of medicinal products. And IMPs are normally not distributed via wholesalers. However IMPs are not particularly excluded. The Guideline may therefore give some guidance on how to supply clinical trial material. Better guidance might be given by the Questions and Answers documents of the European Medicines Agency (EMA). In the part on supplementary requirements, Annex 13, a few Q&As are dealing with storage and transportation of IMPs.

When it comes to transport of IMPs from the manufacturer to the distributor or investigator sites, the sponsor is responsible for controlling the distribution chain and assuring “that IMPs are stored, transported, and handled in a suitable manner”. The responsibility for storage and transportation lies with the manufacturer or an importer, when the IMP comes from outside the EU. To define the specific responsibilities of the parties involved, a contract should be in place.

During storage and transportation, conditions should at least be monitored. The sponsor should define the applicable storage (and transport) conditions for the IMPs. When the IMP arrives at the investigator site, IMPs should be stored in a restricted area where appropriate, with ongoing monitoring. Everything should be defined in SOPs.

 

 

 

 


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DR ANTHONY CRASTO

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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 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......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

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