FDA发布SUPAC-SS非无菌半固体剂型放大及上市后变更最终指南
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
FDA发布SUPAC-SS最终指南，面向拟在上市后变更非无菌半固体剂型的NDA、ANDA和AADA申办者。指南界定变更级别，并给出支持各级变更的化学、制造和控制（CMC）检测、体外释放试验和/或体内生物等效性试验建议及所需文件，适用于乳膏、凝胶、洗剂和软膏等局部给药制剂。文件编号FDA-1997-D-0380，由CDER发布。
文件给出非无菌半固体剂型上市后变更的分级，以及各级变更对应的CMC、体外释放与生物等效性资料建议。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-1997-D-0380
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations to pharmaceutical sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs) who intend to change (1) the components or composition, (2) the manufacturing (process and equipment), (3) the scale-up/scale-down of manufacture, and/or (4) the site of manufacture of a semisolid formulation during the postapproval period. This guidance addresses nonsterile semisolid preparations (e.g., creams, gels, lotions, and ointments) intended for topical routes of administration. The guidance defines (1) the levels of change; (2) recommended chemistry, manufacturing, and controls (CMC) tests to support each level of change; (3) recommended in vitro release tests and/or in vivo bioequivalence tests to support each level of change; and (4) documentation to support the change
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1997-D-0380.
来源：FDA Pharmaceutical Quality Documents · fda.gov