Your stability testing program, including stability-indicating methods and acceptance criteria for each test to support the labeled storage conditions and expiry dates for your products.

你们的稳定性检测计划，包括每项检测的稳定性指示性方法和可接受标准以支持你们药品标示的存贮条件和有效期。

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Release testing program, including a written standard operating procedure (SOP) detailing the test methods you will use to test each product and the acceptance criteria for each test.

放行检测计划，包括一份书面标准操作规程(SOP)，其中详细说明你们将用于检测每种药品的方法以及每种检测的可接受标准。

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