WHO技术转移指南

8. Documentation 文件
8.1 The documentation required for the transfer project itself is wide ranging. Examples of documentation commonly required are summarized in Table 2.
项目转移本身文件要求范围很宽。

常规要求的文件举例归纳在表2中。

8.2 The documented evidence that the transfer of technology has been considered successful should be formalized and stated in a technology transfer summary report. That report should summarize the scope of the transfer, the critical parameters as obtained in the SU and RU (preferably in a tabulated format) and the final conclusions of the transfer. Possible discrepancies should be listed and appropriate actions, where needed, taken to resolve them.
一个技术转移被认为是成功的时候，证明其成功的文件证据需要正式化，并在技术转移总结报告中申明。

该报告应总结转移的范围、转出单位和接收单位所获得的关键参数（最好以表格形式）、转移的最终结论。

应列出可能的差异，如果需要时，应采取可能的措施解决并记录。

Table 2 表2
Examples of documentation for transfer of technology (TOT)
DQ, design qualification; IQ, installation qualification; OQ, operational qualification; API, active pharmaceutical ingredient; SOPs, standard operating procedures; RU, receiving unit.
DQ 设计确认IQ 安装确认OQ 运行确认API 活性药物成分SOPs标准操作规程RU 接收单位
9. Qualification and validation 确认和验证
General 一般说明
9.1 The extent of qualification and or validation (18) to be performed should be determined on the basis of risk management principles.
需要进行的确认和/或验证（18）的深度应在风险管理原则的基础上决定。

9.2 Qualification and validation should be documented.
确认和验证应有记录。

References 参考文件
1. ISPE Good practice guide. Technology transfer. Tampa, FL, International
Society for Pharmaceutical Engineering, 2003.
ISPE 优良规范指南，技术转移，国际药物工业协会，2003
2. WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Forty-second report. Geneva, World Health Organization, 2008 (WHO
Technical Report Series, No. 948).
WHO药物制剂规格专家委员会，第42份报告，日内瓦，世界卫生组织，2008(WHO第948号技术报告)
3. Quality Assurance of Pharmaceuticals. A compendium of guidelines and
related materials, Volume 2, second updated edition. Good manufacturing
practices and inspection. Geneva, World Health Organization, 2007 and related updates; Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials. World Health Organization, 2010 (CD-ROM)
(http://apps.who.int/medicinedocs/en/q/).
药品的质量保证，指南和相关资料摘要，第2卷，第2版。

优良生产和检查规范，日内瓦，世界卫生组织，2007和相关更新；药品的质量保证，指南和相关资料摘要，世界卫生组织，2010 (CD-ROM)
4. Good manufacturing practices for sterile pharmaceutical products In: WHO
Expert Committee on Specifications for Pharmaceutical Preparations.
Thirtysixth report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 957, 2010), Annex 4; WHO Technical Report Series, No.
961, 2011) Annex 6.
灭菌药品优良生产规范，WHO药物制剂规格专家委员会，第36份报告，日内瓦，世界卫生组织，1992 (WHO第957号技术报告，2010)，附件4；
WHO 第961号技术报告，2011 附件6
5. WHO good manufacturing practices: supplementary guidelines for the
manufacture of investigational pharmaceutical products for clinical trials in
humans. In: WHO Expert Committee on Specifications for Pharmaceutical
Preparations. Thirty-fourth report. Geneva, World Health Organization (WHO Technical Report Series, No. 863, 1996), Annex 7.
WHO优良生产规范：用于人临床试验临床药品生产补充指南。

在《WHO 专家委员会关于药品制剂质量标准，第34号报告》，日内瓦，世界卫生组织（WHO技术报告系列，第863号，1996年）附件7
6. ISO 9000:2005, Quality management systems — Fundamentals and
vocabulary.
ISO 9000：2005，质量管理体系–基础和词汇
7. ICH Draft Consensus Guideline. Pharmaceutical Quality System. Q10.
Geneva, ICH Secretariat, 2008 (/LOB/media/MEDIA3917.
pdf, last accessed 27 July 2010).
ICH 一致性指南草案：药物质量体系，Q10，日内瓦，ICH秘书处，2008（最后登录时间2010年7月27日）
8. I CH Harmonized Tripartite Guideline. Pharmaceutical development. Q8
(2R). As revised in August 2009 . Geneva, ICH Secretariat, 2009
(http://www.ich. org/LOB/media/MEDIA4986.pdf last accessed 27 July 2010).
ICH三方协调指南，药物研发，Q8 （2R），2009年8月修订，日内瓦，ICH秘书处，2009（最后登录时间2010年7月27日）
9. ICH Harmonized Tripartite Guideline. Quality Risk Management. Q9.
November 2005. Geneva, ICH Secretariat, 2005 (/LOB/
media/MEDIA1957.pdf, last accessed 27 July 2010).
ICH三方协调指南，质量风险控制，Q9，2005年11月，日内瓦，ICH秘书处，2005（最后登录2010年7月27日）
10. Application of hazard analysis and critical control point (HACCP)
methodology to pharmaceuticals. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization (WHO Technical Report Series, No. 908, 2003), Annex 7.
危险因素分析和关键控制点（HACCP）方法学在药品上的应用，在：
WHO药物制剂质量标准专家委员会，第38号报告，日内瓦，世界卫生组织（WHO技术报告系列，第908号，2003）附件7
11. WHO good manufacturing practices: supplementary guidelines for the
manufacture of pharmaceutical excipients. In: WHO Expert Committee on
Specifications for Pharmaceutical Preparations. Thirty-fifth report. Geneva, World Health Organization (WHO Technical Report Series, No. 885, 1999),
Annex 5.
WHO优良生产规范，药用辅料生产的补充指南。

在：WHO药物制剂质量标准喜剧之王委员会第36号报告，日内瓦，世界卫生组织（WHO技术报告系列，第885号，1999）附件5
12. WHO good manufacturing practices: Active pharmaceutical ingredients (bulk
drug substances) In: WHO Expert Committee on Specifications for
Pharmaceutical Preparations. Forty-fourth report. Geneva, World Health
Organization (WHO Technical Report Series, No. 957, 2010), Annex 2.
WHO优良生产规范：活性药物成分（原料药），在：WHO药物制剂质量标准专家委员会第44号报告，日内瓦，世界卫生组织（WHO技术报告系列，第957号，2010）附件2
13. Sampling of pharmaceutical products and related materials. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations. Thirty-ninth
report. Geneva, World Health Organization (WHO Technical Report Series, No.
929, 2005), Annex 4.
药品和相关物料的取样，在WHO药物制剂质量标准专家委员会，第39号报告，日内瓦，世界卫生组织（WHO技术报告系列，第929号，2005）附件4
14. Guidelines for stability testing of active pharmaceutical ingredients and
finished pharmaceutical products. In: WHO Expert Committee on Specifications of Pharmaceutical Preparations. Forty-third report. Geneva, World Health
Organization, 2009 (WHO Technical Report Series, No. 953), Annex 2.
原料药和制剂的稳定性试验指南，在WHO药物制剂质量标准专家委员会，第43号报告，日内瓦，世界卫生组织，2009（WHO技术报告系列，第953号）附件2
15. The International Pharmacopoeia, 4th ed. Vol. 1: General notices;
monographs for pharmaceutical substances (A–O). Vol. 2: monographs for
pharmaceutical substances (P–Z); monographs for dosage forms and
radiopharmaceutical preparations; methods of analysis; reagents. Geneva, World Health Organization, 2006; The International Pharmacopoeia, 4th ed., 1st
supplement (2008); 2nd supplement (in preparation on CD-ROM, 2011)
(http://www.who.int/medicines/publications/pharmacopoeia/overview/en/
index.html).
国际药典，第4版，第1卷，通则，药物成分各论（A-O），第2卷，药物成分各论（P-Z），制剂和辐射药物制剂各论，分析方法，试剂，日内瓦，世界卫生组织，2006，国际药典，第4版，第一次增补（2008），第二次增补（CR-ROM,2001）
16. Supplementary guidelines on good manufacturing practices for heating,
ventilation and air conditioning systems for non-sterile pharmaceutical dosage forms. In: WHO Expert Committee on Specifications for Pharmaceutical
Preparations. Fortieth report. Geneva, World Health Organization (WHO
Technical Report Series, No. 937, 2006), Annex 2; WHO Technical Report
Series, No.961, 2011) Annex 5.
优良生产规范补充指南，非无菌制剂的暖通系统。

在WHO药物制剂质量标准专家委员会，第40号报告，日内瓦，世界卫生组织（WHO技术报告系列，第937号，2006）附件2，WHO技术报告系列，第961号2011）附件5
17. Water for pharmaceutical use. In: WHO Expert Committee on Specifications
for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization (WHO Technical Report Series, No. 908, 2003), Annex 4.
制药用水。

WHO药物制剂质量标准专家委员会，第37号报告，日内瓦，世界卫生组织（WHO技术报告系列，第908号，2003）附件4
18. Supplementary guidelines on good manufacturing practices: validation. In:
WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Fortieth report. Geneva, World Health Organization (WHO Technical Report Series, No. 937, 2006), Annex 4.
优良生产规范补充指南：验证。

WHO药物制剂质量标准专家委员会，第40号报告，日内瓦，世界卫生组织（WHO技术报告系列，第937号，2006）附件4。