Appendix4Analyticalprocedurevalidation148 Appendix5Validationofcomputerizedsystems160 9 1Appendix6Guidelinesonqualification181 0 2 , 9Appendix7Nonsterileprocessvalidation190 1 0 1 . o N , s e i r e S t r o p e R l a c i n h c
Appendix5. Validation of computerized systems (7). 附录5 计算机化系统验证 ) 。 Appendix6. Guidelines on qualification (8). 附录6 确认指南 (8) 。 Appendix7. Non-sterile process validation (9). 附录7 非无菌工艺验证 (9) 。 Appendix 3, relating to cleaning validation (5), was not updated ...
近⽇，WHO发布了新的清洁验证指南——《不同⽅法——包括HBEL——建⽴清洁验证的残留 限度以确定共⽤设施⽣产污染风险的考量》，该指南解读如下：传统的⽅法是进⾏清洁验证并基于GMP⽂件中建议的接受标准来判断清洁程序的适⽤性。这种 做法可能不再是可以接受的和合理的，因为没有考虑到HBEL。鉴于...
Appendix3. Cleaning validation(5). 附录3 清洁验证(5)。 Appendix4. Analytical procedure validation(6). 附录4。分析方法验证(6)。 Appendix5. Validation of computerized systems(7). 附录5计算机化系统验证)。 Appendix6. Guidelines on qualification(8). 附录6 确认指南(8)。 Appendix7. Non-sterile pro...
TheWHOSupplementaryguidelinesongoodmanufacturingpractice:validationwerepublishedin2006andweresupportedbysevenappendices.The maintext(2)anditsappendixes(3,4,6,7,8,9)wererevisedbetween2006and2019.Appendix3,relatingtocleaningvalidation(5),wasnotupdatedat thattime.Itsrevision,however,wasdiscussedduringaninformalconsul...
•Appendix 2: Validation of water systems for pharmaceutical use- will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems •附件2:制药用水系统的验证——将参考WHO制药用水指南中纯化水系统的确认进行修订。
The WHO Supplementary guidelines on good manufacturing practice: validation were published in 2006 and were supported by seven appendices. The main text and its appendixes were revised between 2006 and 2019. Appendix 3, relating to cleaning validation , was not updated at that time. Its revision,...
7、(5).附录 3:清洁验证Appendix 4. Analytical procedure validation (6).附录 4:分析方法验证Appendix 5. Validation of computerized systems (7).附录 5:计算机化系统的验证Appendix 6. Guidelines on qualification (8).附录 6:确认指南Appendix 7. Non-sterile process validation (9).附录 7:非无菌工艺验...
Appendix 2 Validation of water systems for pharmaceutical use (will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems) 附录2制药用水系统的验证(将通过对WHO制药用水指南水纯化系统确认考虑的交叉索引被替代) ...
There are currently no regulatory guidelines which address this matter, although the data collected from these batches influence the following aspects of the product: stability; process validation; and analytical method develo...