An initiative to expedite thorough extractable/leachables evaluations for patient and product safety, Intertek, a leading quality solutions provider to industries worldwide recently organised and presented a seminar ‘Manage your Extractable & Leachables Risk’ in Mumbai.
The one-day seminar focused on providing detailed information and practical guidance on the issues associated with extractables and leachables (E/L) studies. An important part of pharmaceutical development is the assessment of substances that could potentially leach (leachables) into the drug product from packaging, components of printing ink, catalyst residues and heavy metals.
During his inaugural address at the seminar, Dr Armin Hauk, Senior Consultant, Head of GLP organisation, GMP responsible person acc. Swiss Pharma law said. “Studies of extractable and leachable components within packaging and closures are required to meet the safety requirements for marketed medicines. Intertek undertakes extractables / leachables studies for a wide range of drug products in a variety of packaging types, conducted in accordance with GLP and cGMP requirements.”
He further said, “The seminar was an excellent platform to share Intertek’s valuable knowledge and experience as a global leader in testing services. This will allow companies to gather the information and perspective which they need to make a difference in their business.”
EP News Bureau – Mumbai
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