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Nitrosamines test plan must also be submitted

By Chon, Seung-Hyun | translator Choi HeeYoung

21.07.28 06:19:51

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The MFDS ordered the submission of a drug inspection plan by the 29th for fear of completion and raw material impurities

It must be submitted by May next year


The government is further strengthening pharmaceutical companies' self-inspection of impurities. Plans should be submitted by the end of this month to test for possible Nitrosamine impurities.. The submission of test results is due in May next year.

According to the industry on the 27th, the MFDS recently asked pharmaceutical companies to submit a test plan for drugs that are feared to develop Nitrosamine impurities by the 29th.

Pharmaceutical companies should submit to the MFDS a list of products that are feared to cause impurities, a plan to proceed with the test inspection, and a scheduled date of submission of test results.

If there is a possibility of impurities among

Chon, Seung-Hyun(1000@dailypharm.com)
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