关于分析方法转移

预知子

最近领导让我收集关于分析方法转移方面的指南，我也看了本论坛之前有人上传过几个，如USP1224，ISPE，PDA TR57等，可惜PDA TR57目前还没有人进行分享，除了这些还有哪些指南是和分析方法转移相关的，不吝赐教！

预知子

skycity 发表于 2018-2-9 10:11
http://muchong.com/html/201508/9307078.html
PDA TR57

你太厉害了，非常感谢，目前这个没有中文版的吧，为了表示感谢，我开始着手翻译，然后分享给大家

skycity

http://muchong.com/html/201508/9307078.html
PDA TR57

孙艳红

期待你的中英文分享

预知子

孙艳红 发表于 2018-2-9 11:30
期待你的中英文分享

年前时间不多了，年后奉上

kslam

World Health Organization


GUIDELINES ON VALIDATION – APPENDIX 4
3 ANALYTICAL METHOD VALIDATION
4 (June 2016)
5 DRAFT FOR COMMENTS


8. METHOD TRANSFER
293
294 8.1 During method transfer, documented evidence should be established to prove that a
295 method has equivalent performance when used in a laboratory different from that where it has
296 been originally validated.
297
298 8.2 Generally, it should be performed by comparing a set of results obtained by an analyst in
299 one laboratory to that obtained by another analyst at the laboratory to which the method is being
300 transferred.
301
302 8.3 The two sets of results should be statistically compared and the differences between the
303 two sets of test results should be within an acceptable range.
304
305 8.4 Method transfer should be performed before testing of samples for obtaining critical data
306 for a dossier, such as process validation or stability studies or applied for routine use.
307
308 8.5 A predefined protocol should be followed which includes at least: a title, objective,
309 scope, responsibilities of the sending unit (SU) and the receiving unit (RU); a specification of
310 materials and methods; the experimental design and acceptance criteria; documentation
311 (including information to be supplied with the results, and report forms to be used, if any);
312 procedure for the handling of deviations; references; and details of reference samples (starting
313 materials, intermediates and finished products). The protocol should be authorized and dated.
314
315 8.6 In the case of independent testing by a separate entity, such as a national quality control
316 testing laboratory that is testing samples on its market, method transfer is not always possible. It
317 is not considered an obligation but may be considered as an optional step when encountering
318 difficulties in applying any particular method. See WHO guidelines on transfer of technology in
319 pharmaceutical technology (3) for further reference.

预知子

kslam 发表于 2018-2-9 12:35
World Health Organization

谢谢，这是草案吗？

kslam

linbinbin 发表于 2018-2-9 12:59
谢谢，这是草案吗？

Yes.

Jacob1188

kslam 发表于 2018-2-9 12:35
World Health Organization

老师你能否发一些中文的贴子。哪怕中文也不太连贯也没关系

tianyu0188

不错，学习一下

小金库

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