Elemental impurities – A database to facilitate the risk assessment of active ingredients and excipients

One of the main demands of the Guideline ICH Q3D is to carry out risk assessments on metallic impurities. A database with analytical data provides a valuable support. Learn more about the data sharing using the new elemental impurities database.

http://www.gmp-compliance.org/enews_04843_Elemental-impurities—A-database-to-facilitate-the-risk-assessment-of-active-ingredients-and-excipients_9263,9300,S-QSB_n.html

Released in December 2014, the ICH Q3D Guideline on Elemental Impurities contains extensive specifications for the control of a total of 24 elements (21 metals, 3 metalloids) that can be present as impurities in pharmaceutical products. Main sources can be

  • Active ingredients
  • Excipients (including water)
  • Processing auxiliaries and catalysts
  • Production equipment
  • Container and closure systems

The Guideline ICH Q3D calls for a risk assessment with regard to the presence of metallic impurities in various dosage forms, taking into account the respective limit values. The main factors of influence are to be included (see fishbone diagram on p. 6 of the Guideline). The risks identified in a comprehensive analysis have then to be categorized in a meaningful and justifiable manner.

The data for the content of metallic impurities, e.g. in excipients (for this purpose there is a study conducted by the FDA) or of migratable impurities in container / closure systems (there exists a Literature review in the PDA journal of pharmaceutical science and technology) is rather thin. And the sources of information can only be found through extensive research. The greatest treasure of information is located in the databases of several pharmaceutical and API manufacturers which have carried out analytical studies already.

To merge these data and information and to make them available to all interested companies in the form of a database, representatives of eight major companies have joined forces to an “Elemental Impurities Pharma Consortium”. This group was formed in October 2013, after a Conference on “Elemental Impurities” conducted by the Joint Pharmaceutical Analysis Group (JPAG).

The database that is currently established under the auspices of the EI Pharma Consortium, now comprises analytical data on elemental impurities from over 100 different materials (pharmaceutical excipients, dyes, etc.), which were provided by other companies. These data are anonymized, so that interested users of the database can not recognize the specific origin of the information.

The benefit for the user increases to the same extent as the database grows, which basically means for the companies that have to implement one of the main requirements of the ICH Q3 Guideline – to carry out a risk assessment. The timeframe for this is tight: for medicinal products still to be approved the provisions of ICH Q3D need to be fulfilled by June 2016. Already approved products have to comply from December 2017 (see also our news “Industry Coalition” gives practical advice for the control of elemental impurities in active substances and excipients).

Note : At the Impurities Forum from 16-18 June 2015 in Prague you will receive more information about this topic. Andrew Teasdale, one of the initiators of the Consortium, will report about the database and the possibilities to use it.

 

 

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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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