This paper summarizes some of the approaches taken by the biopharmaceutical industry to save time, resources, and costs, and simplify and continue the supply chain when faced with post-approval changes.
post approval strategies
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This paper summarizes some of the approaches taken by the biopharmaceutical industry to optimize and/or minimize the number of post-approval regulatory notifications and/ or the variation categories associated with product lifecycle changes. It offers a summary of the systematic approach used in the industry for the demonstration of product and process knowledge and the definition of the appropriate process controls that will also
allow future flexibility. This approach can mitigate supply issues that are prevalent in the industry by allowing easier transfers between sites, leading to significant benefits for the patients. There are no novel approaches described in the paper, instead this is a summary of current industry practice. It is intended that this paper is used to review current regulatory practices in existing organizations, and as a reference for new regulatory
professionals and organizations.
Colombia decree consolidated feedback from the BioPhorum Post Approval Change Management workstream, Colombia sub-team. This content is only available to BioPhorum members.
Post-Approval Strategies: Risk-based approach for analytical comparability and comparability protocols
Chemistry, manufacturing, and control post approval changes are an intrinsic part of the life cycle of pharmaceutical products. In this paper, the authors examined the potential impact of such changes on the product quality, safety, and efficacy of biologics. Comparability studies and more specifically analytical comparability are introduced as one of the tools that can support both biomanufacturers and health agencies in ensuring that patient safety and product safety and efficacy is maintained through the proposed changes. Together with a scientific risk-based review approach based on product and process knowledge and the definition of acceptance criteria that will ensure that the product is “essentially similar”, what constitutes a holistic comparability study is detailed. ICH Guidelines principles and definitions are used throughout the paper to aid the reader with other appropriate references. Finally, two case studies are presented: change to the manufacturing facility of the drug substance, and change to the manufacturing process of a drug substance intermediate and manufacturing facility.