| 订单磋商 >> 质量,认证 >>
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句库类别： |
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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