Integrity and Security of Medicinal Products Supply Chains – New Instructions in the US-American Pharmacopeia (USP)

Integrity and Security of Medicinal Products Supply Chains – New Instructions in the US-American Pharmacopeia (USP)
The revision of the General Chapters on Good Distribution Practices (GDP) has highlighted in a new USP chapter the safety and integrity of the supply chains for starting materials and medicinal products. More information can be found in the News.

GMP News
16/04/2014

Integrity and Security of Medicinal Products Supply Chains – New Instructions in

the US-American Pharmacopeia (USP)

A new series of General Chapters on the different aspects of the pharmaceutical supply

chain (“Good Distribution Practices”) which should replace the current chapters on the topic

has been published in the Pharmacopoeial Forum 40(1). A review of the current chapters

(<1079>, <1083> and <1197>) has shown that the contents partly overlap each other.

That’s why these GDP chapters should be reorganised from a higher perspective.

The chapters address material flow beginning with initial procurement and continuing

throughout the supply chain to delivery to the end user.

They apply to APIs, excipients, as well as to medicinal products and medical devices.

The 4 main GDP topics are now organised as follows:

  • 1083.1 Quality Management System
  • 1083.2 Environmental Conditions Management
  • 1083.3 Good Importation and Exportation Practices
  • 1083.4 Suppy Chain Integrity and Security

Supply Chain Integrity and Security (SCIS) is defined as a series of policies,

procedures, and technologies which are used to ensure visibility and traceability of products.

The ultimate objective is to identify falsified or manipulated products and prevent them

from entering the supply chain – and, as a matter of fact – the market.

You can find all information on the USP website of the Pharmacopeial Forum (PF).

Source: USP – http://www.usp.org

 

http://www.gmp-compliance.org/enews_4233_Integrity%20and%20Security%20of%20Medicinal%20Products%20Supply%20Chains%20-%20New%20Instructions%20in%20the%20US-American%20Pharmacopeia%20%28USP%29_8447,S-RPV_n.html

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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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