Shane P Smith
ExtLe Solutions Ltd., UK
Title: Six essential do’s and don’ts for an effective GMP extractables and leachables strategy
Biography
Biography: Shane P Smith
Abstract
The subject of extractables and leachables has become an increasingly hot topic within regulatory agencies over recent years, especially with the increase of single use technologies in the manufacture of API/BDS and drug products. In addition, new guidance documents and pharmacopeial updates are driving the need for a thorough understanding of how extractables and leachables may affect the quality and efficacy of a drug product. This presentation will discuss key issues to consider whilst developing and executing a scientifically robust, and cost/resource effective GMP extractables and leachables strategy.