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EL Seminar organized by Intertek held in Mumbai

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An initiative to expedite thorough extractable/leachables evaluations for patient & product safety

Intertek, a leading quality solutions provider to industries worldwide organised and presented a seminar “Manage your Extractable & Leachables Risk” on Wednesday, 9th April 2014 at The Lalit, Mumbai. This 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. E/L studies provide qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product. The seminar provided insightful details regarding analytical approaches for evaluating E/L from different sources such as packaging or printing inks and also expert guidance on how to interpret analytical data in order to gain insight into risk assessment and validation of different manufacturing processes from an extractables and leachables perspective.

Key Topics of Discussion

  • Regulatory requirements and the basics of polymer stabilization and degradation required in packaging of process
  • Benefit of extractables and leachables testing for understanding the influence of material used in pharmaceutical process
  • Concepts of designing and executing E&L studies of container closure system.
  • E&L strategies for process material like tubing, filter media etc.

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 added, “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”.

Intertek provides expertise in E/L studies from our centres of excellence in India (Mumbai, Europe (Basel) and the USA (Whitehouse, New Jersey).

 

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