2019.12.30日，QA姚华君在查看稳定性留样计划及跟踪表时，发现

On December 30th, 2019, QA Yao Huajun found that the stigmatomycin sulfate concentrated liquid separation and elimination process had been produced while viewing the stability retention plan and tracking table, but it did not comply with its enterprise standard, WHO registration standard, domestic standard and U.S. registration standard. Perform stability retention samples (H0-SOP-72011 version 01 stability test management program 6.2.1 requirements: API products, unless there is no production in the year, at least one batch of long-term stability test should be conducted each year)

On 2019.12.30, QA Yao Huajun, while reviewing the stability sample plan and tracking table, found that the sulphate curlymycin concentrate separation process was produced, but did not carry out stability samples for its enterprise standards, WHO registration standards, domestic standards and U.S. registration standards (H0-SOP-72011 01 stability test management procedure 6.2.1 requirements: API products, unless there is no production, at least one long-term batch of stability tests should be carried out each year).

On December 30, 2019, when Yao Huajun, QA, checked the stability retention plan and tracking table, he found that the separation and elimination process of capreomycin sulfate concentrate had been produced, but he did not carry out the stability retention for its 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.