During their production, storage/distribution and administration, small volume parenteral drug products leach chemicals from their manufacturing, packaging, and delivery systems. These foreign impurities (leachables) can potentially have a significant effect on the quality of the SVPs and may affect the efficiency with which the SVP is produced. To establish the effects of these impurities, drug products are profiled for leachables and manufacturing, packaging, and delivery systems are tested for extractables (as probable leachables).
In this presentation, the scientific and practical aspects and principles of the chemical characterization of SVPs and their related systems will be introduced; including a review of the relevant regulatory guidance, standards and best demonstrated practice recommendations. The presentation will provide suggested best practices (dos and don’ts) for the design, implementation, interpretation, and submission of E&L studies.
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