On December 30, 2019, when Yao Huajun, QA, checked the stability retention sample plan and tracking table, he found that the separation and elimination process of capreomycin sulfate concentrate had been put into production, but he did not conduct stability retention sample for the products of enterprise standard, who registration standard, domestic standard and American registration standard (version h0-sop-72011 01) Stability test management procedure 6.2.1 requirements: API products, unless not produced in the current year, shall be subject to at least one batch of long-term stability test every year.
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