parameters (both validation and commercial production), sterilization and depyrogenation equipment, process limits and acceptance criteria, load sizes, and load composition.
例如:在灭菌和去热源工艺方面,设计空间可能包括工艺参数(验证和营利生产),灭菌和去热源设备,工艺限值和可接受的标准,负载大小,和负载组成。
Q: How should DMFs be referenced? 问题:DMF如何被引用?
A: If the information for a particular section is contained within a DMF and not available to the applicant, then
reference the appropriate DMF for the specific process at that location in the SA-QOS. The reference should include a description of the type of information in the DMF, the DMF holder’s name, the DMF number, and the submission date and page numbers/sections in the DMF containing the appropriate information. Note that LOAs should contain similar identifying information.
答:如果特别章节的信息包含在DMF中且并不可用于申请者,对于位于SA-QOS中具体工艺(过程),要
引用合适的DMF。引用内容应该包括DMF中信息类型的描述,DMF持有人的名字,DMF编号,和含有合适信息的DMF中的提交日期和页码/章节。注意到LOAs应该包含相似的识别信息。
Q: How should studies be correctly identified in SA-QOS? 问题:研究如何正确地在SA-QOS中识别?
A: Any type of study that is provided in the SA-QOS should be identified with a title, report number, and date, if
available.
答:提供在SA-QOS中的研究的任何类型应该有标题,报告编号,和日期被识别,如果适用。 Q: Is the current SA-QOS Outline applicable for applications for products manufactured by a
terminal sterilization process other than moist heat?
问题:对于非湿热最终灭菌工艺的产品,现行的SA-QOS大纲是否适用于申请者?
A: This document only applies to products terminally sterilized by moist heat and was designed with this type of
terminal sterilization process in mind. However, some of the same principles and details can apply to other processes.
答:这个文件仅适用于通过湿热最终灭菌的产品,并且以这种最终灭菌工艺类型设计。但是,一些部分
原则和详细信息能适用于其他的流程。
Q: Will a SA-QOS Outline be made available for products manufactured by aseptic processing and not by
terminal sterilization?
问题:对于无菌工艺生产但是非最终灭菌的产品,SA-QOS 大纲能否产生?
A: Yes, it is currently being developed and will be made available at a later date.
答:是的,这是当前正在发展的,并且在以后将会变成可行。 SUGGESTED READING 建议阅读
ANSI/AAMI/ISO 11135-1:2007 ―Sterilization of health care products — Ethylene oxide
— Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices‖ “保健品灭菌-环氧乙烷”-1部分:医疗设备灭菌工艺的开发,验证,日常控制的需求 ANSI/AAMI/ISO 11137-1:2006 ―Sterilization of health products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices‖ “保健品灭菌-辐射” -1部分:医疗设备灭菌工艺的开发,验证,日常控制的需求
ANSI/AAMI/ISO 11137-2:2006 ―Sterilization of health products – Radiation – Part 2: Establishing the sterilization dose‖ “保健品灭菌-辐射” -2部分:确立灭菌剂量
ANSI/AAMI/ISO 11137-3:2006 ―Sterilization of health products – Radiation – Part 3: Guidance on dosimetric aspects‖ “保健品灭菌-辐射” -3部分:剂量测定指南
Food and Drug Administration. ―Guidance for Industry: Comparability Protocols – Chemistry,
Manufacturing, and Controls Information‖ (Draft Guidance) February 2003 食品药品管理局 “工业指南:相似性方案-化学,生产,和控制信息”(指南草案)2003年2月
Food and Drug Administration. ―Guidance for Industry: Container and Closure System Integrity Testing in
Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products‖ February 2008 食品药品管理局 “工业指南:容器密封系统完整性测试代替灭菌测试作为灭菌产品的稳定性方案的组成”2008年2月
Food and Drug Administration. ―Guidance for Industry for the Submission Documentation for Sterilization
Process Validation in Applications for Human and Veterinary Drug Products‖ November 1994 食品药品管理局 “人兽药品灭菌工艺验证的提交文件的工业指南”1994年
Food and Drug Administration. ―Guidance for Industry: Q8(R2) Pharmaceutical Development‖ (Revision 2)
November 2009 食品药品管理局 “工业指南:Q8(R2)药物开发”(修订2)2009年11月
Food and Drug Administration. ―Guidance for Industry: Q9 Quality Risk Management‖ June 2006 食品药品管理
局 “工业指南:Q9 质量风险管理” 2006年6月
Food and Drug Administration. ―Guidance for Industry: Q10 Pharmaceutical Quality System‖ April 2009 食
品药品管理局 “工业指南:Q10 制药质量体系” 2009年4月
Food and Drug Administration. ―Guidance for Industry: Submission of Documentation in Applications for
Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes‖ February 2010 食品药品管理局 “工业指南:湿热最终灭菌人兽药品参数放行应用文件的提交” 2010年2月
Food and Drug Administration. ―Guideline on Validation of the Limulus Amebocyte Lysate Test as an
End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices‖ December 1987 食品药品管理局 “对人兽注射药物,生物产品和医疗设备产品内毒素测试的鲎试验的验证指南”
Langille, S., Ensor, L., and Hussong, D. ―Quality by Design for Pharmaceutical Microbiology‖ American
Pharmaceutical Review, Volume 12 (Issue 6), pages 80-85, September/October 2009 “药物微生物学质量设计” 美国制药综述
Metcalfe, J. ―Microbiological Quality of Drug Products after Penetration of the Container System for Dose
Preparation Prior to Patient Administration‖ American Pharmaceutical Review, Volume 12 (Issue 1), pages 84-89, January/February 2009 “为病人准备的药物剂量溶出之后的微生物质量” USP Chapters: USP章节
<1> Injections 注射剂
<51> Antimicrobial Effectiveness Testing 抗菌剂效力测试 <71> Sterility Tests 灭菌测试
<85> Bacterial Endotoxins Test 细菌内毒素测试 <151> Pyrogen Test 热源测试
QUALITY OVERALL SUMMARY CONTENT QUESTIONS 质量综述内容问题
Review of Common Technical Document-Quality (CTD-Q) Module 2.3: Quality Overall Summary
模块 2.3 一般技术性文件质量(CTD-Q)的回顾:质量综述
2.3.P 2.3.P.1
DRUG PRODUCT 药品
Description of the Composition of the Drug Product 药品组成的描述
? Description of drug product ? 药品的描述
What is the final dosage form and route(s) of administration? 最终剂型和给药途径是什么?
Q: What information should be presented in this section?
问题:此章节应该提供什么信息?
A: Indicate the dosage form and route(s) of administration. 答:提出剂型和给药途径
Examples of dosage forms include: 剂型例子包括: Injection, solution 注射剂,溶液 Injection, emulsion 注射剂,乳液 Injection, suspension 注射剂,悬浮液
Injection, powder (for solution or for suspension) 注射剂,粉针(为溶液或悬浮液准备)
Injection, powder, lyophilized (for solution or for suspension) 注射剂,粉针,冻干(为溶液或悬浮液准备) Solution 溶液 Suspension 悬浮液 Irrigant 冲洗剂 Ointment 药膏
Examples of routes of administration include: 给药途径的例子包括: Intravenous 静脉的 Intramuscular 肌肉的 Subcutaneous 皮下的 Intrathecal 鞘内的 Epidural 硬膜上的 Otic 耳部的