新申报产品工艺验证批是否可以销售，国内国外是否有法规要求
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2020-01-13 10:31 1907QA     
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在复验期内，获批后，欧洲很明确是可以销售的

2020-01-13 15:50 Cora     
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1907QA 2020-01-14 08:43

美国有这方面的要求吗。欧盟的法规分享一下吧，谢谢

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Hscszm 2020-01-14 09:02

可参考欧盟GMP附录15确认与验证，5.14. Where validation batches are released to the market, this should be pre-defined. The conditions under which they are produced should fully comply with GMP, with the validation acceptance criteria, with any continuous process verification criteria (if used) and with the marketing authorisation or clinical trial authorisation.

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Cora 2020-01-14 11:15

参考识林问题问答 Q6Webinar on the newly revised EDQM Guideline on requirements for revision/renewal of Certificates of Suitability

修订/更新CEP的要求 新版EDQM指南研讨会

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