FDA发布SUPAC制造设备附录草案，合并并替代两份SUPAC附录
SUPAC: Manufacturing Equipment Addendum
FDA发布SUPAC制造设备附录草案，该草案合并并替代SUPAC-IR/MR与SUPAC-SS两份制造设备附录。草案删除两份附录中的制造设备清单并澄清所引用的工艺类型，标注为2014年12月草案、不用于实施，属非约束性建议。文件编号为FDA-2013-D-0295，可通过线上或书面方式随时提交意见。
草案合并并替代两份SUPAC制造设备附录，删除原有设备清单并澄清所引工艺类型，可帮助读者了解变更申报需核对的设备范围。
GUIDANCE DOCUMENT
SUPAC: Manufacturing Equipment Addendum December 2014
Draft
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2013-D-0295
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance combines and supersedes the following scale-up and post-approval changes (SUPAC) guidances for industry: (1) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, and (2) SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum. It removes the lists of manufacturing equipment that were in both guidances and clarifies the types of processes being referenced.
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-2013-D-0295.
来源：FDA Pharmaceutical Quality Documents · fda.gov