On December 30, 2019, QA personnel Yao Huajun found that the separation and digestion process of capreomycin sulfate concentrate had been put into production when checking the stability retention sample plan and tracking table, but no stability retention sample (version h0-sop-72011 01) was carried out for the products of its enterprise standard, who registration standard, domestic standard and American registration standard 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.<br>
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