ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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SUPAC (Scale-Up Post Approval Changes)

Guidance documents developed by the Center for Drug Evaluation and Research (CDER) as a means of maintaining product safety, efficacy, and quality, while providing substantial regulatory relief and flexibility to manufacturers. The SUPAC guidance documents make recommendations to drug product sponsors who intend the post-approval changes to the product in: the components or composition, the site of manufacture, and/or the manufacturing process and equipment.

The concept of SUPAC is based on 21 CFR 314.70(a). There are six SUPAC guidance documents currently in existence or development, and FDA has asked ISPE to produce addenda for these as well.

1. Immediate Release (SUPAC-IR) Solid Oral Dosage Forms

2. Modified Release (SUPAC-MR) Solid Oral Dosage Forms

3. Nonsterile Semi-Solid (SUPAC-SS) Dosage Forms

4. Transdermal Products (SUPAC-TDS) – in development

5. Bulk Additives (BACPAC) – in development

6. Aqueous Solutions (PAC-SAS) – in development

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