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.
post approval
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