Postapproval changes

Food and Drug Administration Guidance for Industry. SUPAC-MR Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, October 1997. 

Figure 4 Postapproval changes of IR forms supported by in vitro dissolution data according to SUPAC-IR guidance.

It provides for optional update of P2 for adding knowledge for postapproval change ... 

SUPAC-IR Immediate release solid oral dosage forms scale-up and postapproval changes chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation (november 1995)... 

The process of scale-up in the pharmaceutical industry generally involves moving a product from research and development into production. Numerous pitfalls could be met on this path. It is a well-known fact that often the production process cannot achieve the same product quality as was envisioned in the development and pre-approval stages. Losses in terms of effort and money can be enormous, which is why scale-up and postapproval changes are so important and so strictly regulated. 

Changes in Batch Size Postapproval changes in the size of a batch from the pilot scale used to manufacture product for clinical trials to larger or smaller commercial batch sizes require submission of additional information in the apphcation. Scale-down below 100,000 dosage units is not covered by this guidance. All scale-up changes should be properly validated and, where needed, inspected by appropriate FDA personnel. 

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