Revised USP Chapter on Visual Inspection published

After the long-awaited Chapter <1790> on visual inspection of injections was first published in the PF 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Read more about the revised draft of the USP Chapter <1790>.

http://www.gmp-compliance.org/enews_05091_Revised-USP-Chapter–1790–on-Visual-Inspection-published_15154,Z-PEM_n.html

After the long-awaited Chapter <1790> Visual Inspection of Injections was first published in the Pharmacopeial Forum 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Through its number >1000, the monograph <1790> is not binding but rather offers an explanation to Chapter <790> Visible Particulates in Injections.

With regard to the content, several comments recommended by the industry have been included. The new Chapter 9 represents the biggest change and describes the evaluation of marketed products where anomalies had been observed regarding particles. The test procedure for it is described in Chapter <790>. Yet, this topic was missing in the original draft of Chapter <1790>. Thus, in total there is one more chapter. In addition, the underlying test statistics contained in the chapter on inspection of lyophilised product have been detailed. The requirements on the premises for manual inspection have also been added in more detail. Moreover, a clear statement can be found on the validation of a fully automatic system which should be based on the comparison with the compendial manual inspection.

The draft document is available for free on the website of the USP Pharmacopeial Forum. You only need to register for free. The deadline for comments is 31 Januar 2016. The new chapter could be published in the USP 40 in November 2016 and becomes effective as of May 2017. A document comparing the original and the second draft can be found on the website ofECA’s Visual Inspection Group, under useful links.

/////////

Advertisements

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

One thought on “Revised USP Chapter on Visual Inspection published”

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s