术语“偏差”和“不符合”是同义词么？

kslam

ICH Q7 Guideline: Good Manufacturing Practice Guidefor Active Pharmaceutical Ingredients Questions and Answers 10 June 2015

ICH Q7指南：原料药GMP指南问答 2015-6-10

Q: Are the terms ‘deviation’ and ‘nonconformance’ synonyms?
问:术语“偏差”和“不符合”是同义词么？

A : No. However, they are related. The term ‘deviation’, as used in ICH Q7, refers to a ‘departure from an approved instruction or established standard’ that may or may not have an impact on the quality of the material. ‘Non-conformance’ refers to a status as a result of a failure of the material to meet specifications or appropriately established standards that impacts the quality of the material [ICH Q7, Sections 2.50, 14.30, 20].

答: 不是。但是他们具有相关性。术语“偏差”，用在ICH Q7里，表示“偏离批准的指令或订立的标准”，它可能会也可能不会对物料的质量形成影响；而“不符合”则表示一个物料的检查结果不符合质量标准或已建立的适当的标准，对物料质量会产生影响（ICH Q7，第2.50，14.30，20部分）。

空灵

有道理，不符合是偏差，偏差不一定造成不符合   

newfellow

偏差是一种状态
不符合是结论

newfellow

就像OOS 需要调查，结论可能是不符合或者符合

kuaileyaoyao

空灵 发表于 2015-7-5 15:56
有道理，不符合是偏差，偏差不一定造成不符合

同意，但是这两个是不是都有可能可以引起CAPA呢？

空灵

kuaileyaoyao 发表于 2015-7-5 20:38
同意，但是这两个是不是都有可能可以引起CAPA呢？

都可以引起CAPA

syhorchid

同意楼上观点

wx_QlKU9St9

学习一下，谢谢分享。

yonyou

路过学习了

beiwei5du

关于non-conformance,non-conformity,non-compliance的区别能不能具体解释一下呢？非常感谢。

kslam

beiwei5du 发表于 2016-7-2 12:22
关于non-conformance,non-conformity,non-compliance的区别能不能具体解释一下呢？非常感谢。

Non-compliance is the failure to adhere to an Act or its Regulations
Non-conformance is the failure to comply with a requirement, standard, or procedure.

beiwei5du

kslam 发表于 2016-7-2 12:30
Non-compliance is the failure to adhere to an Act or its Regulations
Non-conformance is the failu ...

3. Editorial Changes (§§ 211.84(d)(3) and 211.160(b)(1))
We proposed minor editorial changes to two regulations, §§ 211.84(d)(3) and 211.160(b)(1). The version of § 211.84(d)(3) amended by this final rule stated: ‘‘Containers and closures shall be tested for conformance with all appropriate written procedures.’’ We proposed to replace the word ‘‘conformance’’ with ‘‘conformity’’ and the word ‘‘procedures’’ with ‘‘specifications.’’ The first sentence of the version of § 211.160(b)(1) amended by this final rule stated: ‘‘Determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products.’’ We proposed to replace the word ‘‘conformance’’ with ‘‘conformity’’ and the word ‘‘appropriate’’ with ‘‘applicable.’’ We stated in the preamble to the direct final rule that these revisions would provide clarity without changing the meaning or intent of these regulations. We received no comments on these proposed changes, and we have revised these provisions as proposed
选自：https://www.fda.gov/ohrms/dockets/98fr/e8-20709.pdf
那么如此一来，和楼主的问答是否有一定的冲突？？conformance应该是看做是否准寻相应的precedures，这个和deviation有定的区别（主要是程度上），欧盟的的GMDP的检查数据库也经常针对于不符合项使用的non-conformance，这个与题主所涉及的是否符合标准是有一定的不一致。而从这个federal register发布的公告中提及的相关修订，也设计到conformity，这个可能才和相应的是否符合标准有关。
但是但是为什么我在cGMP中也找到了相应的conformance to specification的用词？？？那么为什么此处会有这样的调整？？？？

(b) For each batch of ophthalmic ointment, there shall be appropriate testing to determine conformance to specifications regarding the presence of foreign particles and harsh or abrasive substances. The test procedures shall be in writing and shall be followed.

(c) For each batch of controlled-release dosage form, there shall be appropriate laboratory testing to determine conformance to the specifications for the rate of release of each active ingredient. The test procedures shall be in writing and shall be followed.

kslam

beiwei5du 发表于 2017-8-5 05:56
3. Editorial Changes (§§ 211.84(d)(3) and 211.160(b)(1))
We proposed minor editorial changes t ...

6) Terms relating to Conformity


Terms relating to Conformity as defined in ISO 9000:2005 are:
6.1) Conformity


ISO 9000 definition:
“Fulfillment of a requirement”
NOTE The term “conformance” is synonymous but deprecated.