The guide also provides recommendations for facility and equipment design, drawing from aseptic manufacturing practices and scaled to meet the needs of 503B facilities. In addition, it presents industry best practices for aseptic manufacturing, emphasizing personnel training and qualification.
Additionally, the ISPE 503B Guide addresses microbiological and analytical testing, including verifying the suitability of compendial methods and validating non-compendial methods. It covers beyond-use dating, offering essential insights into limited stability testing, and stability best practices. A dedicated chapter on preparing for regulatory inspections provides facilities with a valuable resource.
In 2023, ISPE also established the Pharmaceutical Compounding Community of Practice (CoP), which seeks to foster innovation to improve the practice of pharmaceutical compounding, and to disseminate ideas, knowledge, and best practices. This is done through the generation of ISPE content, including guidance documents, Pharmaceutical Engineering® magazine articles, webinars, blog posts, conference presentations, and training materials.
The new CoP provides a venue for industry and regulatory informal interactions to drive practical and effective design and operational practices. It also addresses regulatory expectations and provides solid scientific justification for practices accepted by industry and regulators alike.
ISPE members interested in being considered to participate on the recently established Steering Committee leading the ISPE Pharmaceutical Compounding CoP are urged to email ISPE at communities@ispe.org
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