The FDA has announced the establishment of a docket to solicit public comment on the following guidances for industry on scale-up and post-approval changes (SUPAC) for specific dosage forms:
FDA uses a risk-based approach for recommending the reporting of chemistry, manufacturing, and controls (CMC) changes that could affect the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. Using a risk-based approach reduces regulatory burden by clarifying what reporting is necessary based on the likelihood that changes will affect the safety or effectiveness of a drug product. The SUPAC guidances describe the recommended testing and documentation that should be submitted for component and composition changes, manufacturing process and equipment changes, manufacturing scale changes, and manufacturing site changes.
The core principle of a risk-based approach for recommending the reporting of CMC changes as described in the SUPAC guidances remains relevant, but the guidances may benefit from updates to ensure they reflect current expectations, risk assessment strategies, and contemporary scientific and technical considerations. Therefore, FDA is seeking feedback and suggestions about possible revisions to the guidances.
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