Dr Ingrid Markovich, FDA, has committed to making a live presentation of the US FDA’s leachables and extractables (L&E) expectations for pharmaceutical products via web-conference at iSmithers second Leachables & Extractables for Pharmaceutical Products conference in Barcelona.

Dr Markovich, Expert Review Scientist at the FDA joins the conference programme to present her paper titled, ‘Scientific and regulatory considerations for extractable and leachable substances in therapeutic biologics: Sources, methods and case studies’.  “This latest addition to the speaking panel has ensured that the requests from delegates at our 2008 conference have all been responded to making this conference a must attend event for any pharmaceutical producer or polymer manufacturer that wishes to participate in the global pharmaceutical market” said a spokesperson from iSmithers.   

This conference will now provide insight into the activities of FDA, UK Medicines and Healthcare Regulatory Authority (MHRA), Bio-Process Systems Alliance (BPSA), Product Quality Research Institute (PQRI), International Pharmaceutical and Aerosol Consortium on Regulation & Science (IPAC-RS), pharmaceutical manufacturers and polymer producers – making it the most comprehensive L&E conference available to the industry. Sessions on the regulatory climate, L&E in orally inhaled and nasal drug products, other areas of L&E concern, L&E testing, case studies and the polymer producers perspective will be covered in depth.

There will be a regulatory question and answer session when questions submitted prior to the conference will be answered by a live expert panel consisting of:

§        Dr Diane Paskiet - West Pharmaceuticals & Product Quality Research Institute (PQRI),

§        Dr Rachel Hawkins - Medicine and Health Regulatory Agency (MHRA), 

§        Dr Doug Ball - Pfizer & PQRI and

§        Jerold Martin - Pall Life Sciences & Bio-Process Systems Alliance(BPSA).

Recalling products is a costly exercise, and with escalating pressure on the pharmaceutical industry to identify, quantify and monitor impurities, developments in leachables and extractables are increasingly important.

Leachables and extractables have been considered by regulatory authorities and the pharmaceutical industry for a number of years and the FDA formalised this by requiring NDAs and ANDAs to demonstrate that they had been considered in relation to closure systems. Until recently, efforts concentrated orally inhaled and nasal drug products (OINDPs) as these have the highest risk of leachables and extractables . Recently, the industry has shifted to look at the risk of leachables and extractables on all drug products and medical devices  in an effort to increase quality throughout the industry.