FDA发布人用和兽用药品灭菌工艺验证申报文件最终指南
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
FDA发布最终指南，就人用和兽用药品申请中提交支持灭菌工艺有效性的信息和数据提供建议。指南适用于无菌药品的新药申请、新兽药申请、简略新药申请、简略抗生素申请和简略新兽药申请，也适用于已批准药品提交无菌工艺相关补充申请的情形。指南还列出对相关指南文件的评论提交方式，档案编号为FDA-2013-S-0610。
GUIDANCE DOCUMENT
Final
- Issued by:
-
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
This document is intended to provide guidance for the submission of information and data in support of the efficacy of sterilization processes in drug applications for both human and veterinary drugs. The recommendations in the guidance apply to applications for sterile drug products (new drug applications, new animal drug applications, abbreviated new drug applications, abbreviated antibiotic applications, and abbreviated new animal drug applications). These recommendations also apply to previously approved applications when supplements associated with the sterile processing of approved drugs are submitted. Information and data in support of sterility assurance may also be necessary in investigational new drug and investigational new animal drug applications.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov