FDA 发布 Q5E 生物技术/生物制品生产工艺变更可比性最终指南
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
FDA 发布 Q5E 最终指南，阐述生物技术/生物制品在生产工艺变更前后可比性评估的原则。文件由 CDER 与 CBER 共同发布，重点放在质量方面，不规定特定的分析、非临床或临床策略。书面意见需标注文件编号 FDA-2004-D-0440。
该最终指南说明生物技术/生物制品生产工艺变更前后可比性评估的原则，重点放在质量方面，并不规定具体分析或临床策略。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2004-D-0440
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. Therefore, this guidance is intended to assist manufacturers of biotechnological/biological products in the collection of relevant technical information that serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety, and efficacy of the drug product. The document does not prescribe any particular analytical, nonclinical, or clinical strategy. The main emphasis of the document is on quality aspects.
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-2004-D-0440.
来源：FDA Pharmaceutical Quality Documents · fda.gov