Studies of extractable and leachable components within packaging systems and closures have become mandatory requirement to meet the safety requirements for marketed medicines. This area of growing regulatory significance provides many challenges in the development and analysis of Extractables and Leachables for inhalation, ophthalmic and injectable drug products. In order to obtain successful regulatory approval for new drug applications, packaging interactions with the drug product should be evaluated to ensure product safety.
According to the USFDA cosmetic Act section 501 (a)(3)“A drug is deemed to be adulterated if its container is composed in whole or part of any poisonous or deleterious substance which may render the contents injurious to health”. This webinar outlines FDA risk analysis, the FDA’s quality control approach and factors to be considered during studies of Extractables and Leachables.
Development and Evaluation studies of E & L include evaluation of packaging material COA; solvent extraction studies using varying polarity solvents; Identification and Quantification on LC-MS and GC-MS; identification of toxic and geno-toxic compounds; toxicity evaluation as per Derek Nexus software; validation of developed analytical methods and leachable studies during the shelf life of a product.
Join Piramal Pharma Solutions in this webinar to understand what Extractables and Leachables are and to obtain successful regulatory approval.
Dr. Balkrishna Agarwal,
Group leader-Analytical-Pharmaceutical R & D, Piramal Pharma Solutions
Dr. Balkrishna Agarwal having is a HOD of GLP analytical lab, serving at leading pharmaceutical company, Piramal Pharma Solution, Mumbai. Dr. Balkrishna has contributed his significant 11 years to pharmaceutical industry. He has pursued his Doctorate degree in the field of Analytical Chemistry from Mumbai University.
After completing his education, he started working with one of the renowned pharmaceutical company-IPCA laboratories in the year 2005 till 2007. From Dec 2007 he is working with Piramal Pharma Solution. Since 2010 he is involved in evaluating extractable and leachable data and developing in-house skill in Piramal Pharma Solution.
Mr. Abhishek Shah,
Research Associate- Analytical-Pharmaceutical R & D, Piramal Pharma Solutions
Abhishek Shah is a Research Scientist serving at leading pharmaceutical company, Piramal Pharma Solutions, Mumbai. He has pursued his Masters of Pharmacy degree in the field of Pharmaceutical Analysis at the well reputed School of Pharmacy and Technology Management, NMIMS University, Mumbai in the year 2011.
After completing his education, he started working with Piramal Pharma Solutions and since then he is working with the organisation on various challenging roles streamlining projects. As a young research scientist, Abhishek has devoted his time in learning and developing techniques in Extractable and Leachable for pharmaceutical container closures.
- To understand What is Extractable and Leachable and impact on product quality
- Regulatory requirements for Extractable and Leachable
- Development studies of extractable and leachable
- Evaluation and submission of leachable data to regulatory agencies
- Research Associate-Analytical
- Research Scientist-Analytical
- Analytical Group Leader
- Analytical Head of Department
- Manager-Analytical Development
- Analytical Executive
- Analytical Officer
- Executive-Regulatory Affairs
- Manager-Regulatory Affairs
- Head of Research and Development
