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 订单磋商 >> 质量,认证 >> 
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订单磋商
英文:
A: We are a non-GMP manufacturer of this product. Is the GMP necessary? Please confirm. B-1: Either GMP or following equivalent practices. As these are Intermediates we require Vendor documents and site Audit for Qualification. B-2: Product GMP is not must, factory GMP/State GMP/Local GMP are also workable. B-3: Without GMP is ok. B-4: First of all thanks for your prompt reply. As this item is an advance intermediate, we need US FDA approved or approvable facility. Can you please let us know price f rom non-GMP site? also share COA.
中文:
A:我们是非GMP工厂,GMP是必须的吗?请您确认一下。 B-1:GMP或遵循同等做法。由于这些是中间体,我们需要供应商文件和现场审核才能获得资格。 B-2:产品的GMP是不需要的,需要工厂有GMP。 B-3:没有GMP也可以的。 B-4:首先感谢您这么快的回复。这个产品是一个高级中间体,我们需要美国FDA认证或可以FDA认证的工厂。请您确认一下非GMP工厂产品的价格,并分享一下COA。
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