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  • Nitrosamines test plan must also be submitted
  • by Chon, Seung-Hyun | translator Choi HeeYoung | Jul 28, 2021 05:56am
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 the drugs currently being produced
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