The “Industry Coalition” gives practical advice for the control of elemental impurities in active substances and excipients

The requirements of the “Guideline for Elemental Impurities ICH Q3D” published in December of last year mean a considerable expense for the affected pharmaceutical companies and drug manufacturers in terms of laboratory and personnel upgrading (see also our news about “ICH Q3D – Elemental Impurities” of 07 January 2015). In addition, the deadlines for the implementation of this guideline are quite tight. (June 2016 for newly approved drugs and December 2017 for already approved drugs, see our news “CHMP adopts ICH Q3D Guideline as “Scientific Guideline” of 21 January 2015).

In the March issue of “Pharmaceutical Technology Europe”, an article of the “Industry Coalition” has been published with the title “Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities“, which is intended to support the efffected companies with a number of pragmatic pieces of advice in the implementation of these requirements.

The “Industry Coalition” (exact name: “Coalition for Rational Implementation of Elemental Impurities Requirements”) is a consortium of economic/industrial associations (members include IPEC Europe, IPEC Americas, The Generic Pharmaceutical Association GPhA, etc.) and has been in existence since 2011. The aim of the coalition is to provide information regarding elemental impurities. To this end, the Coalition has developed a standardised procedure (standardised information request) according to which specific information can be requested through the use of a form. More information about the “Industry Coalition”, their goals and projects can be found in a Position Paper which appeared in “Pharmaceutical Technology Europe” in November 2012.

The Guideline ICH Q3D calls upon drug manufacturer to conduct a risk assessment as part of a strategy for the control of element impurities, but without specifying which aspects need to be considered in such an assessment. Here, the article of the “Industry Coalition” provides helpful hints; it is described how, for example, production equipment (various types of steel), processing aids (activated carbon, silica gel, etc.), inorganic reagents, solvents, packaging materials and closure systems are to be included in the risk assessment. A detailed section is dedicated to the subject of excipients, regarding which the assessment of risks is often particularly difficult in terms of element impurities, due to the unclear origin or the complex composition of the excipients.

The approaches described by the “Coalition” may be useful for many companies in their efforts to meet the requirements of the Guideline ICH Q3D. In this context, the document which has recently been published by the EMA  entitled “Elemental impurities in marketed products. Recommendations for implementation” should also be considered……………..http://www.gmp-compliance.org/enews_04794_The-%22Industry-Coalition%22-gives-practical-advice-for-the-control-of-elemental-impurities-in-active-substances-and-excipients_9343,9263,9300,S-QSB_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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