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Remote GMP inspections not recognized from April

By Lee, Hye-Kyung | translator Kim, Jung-Ju

24.01.28 10:43:32

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MFDS will only recognize on-site GMP inspection reports

From this year, preliminary GMP evaluations will also be conducted entirely on-site


The GMP inspections, which were temporarily allowed non-face-to-face due to the difficulty of on-site evaluations during the COVID-19 outbreak, are gradually returning to ordinary procedures.

After switching the pre-approval GMP item inspections back to full on-site inspections in December last year, the Ministry of Food and Drug Safety (MFDS) now decided to recognize only on-site reports rather than the written reports, which had been recognized for a limited time due to difficulties in conducting on-site inspections.

From April 25, the only written reports the MFDS will accept are vendor audit results from on-site inspections.

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Lee, Hye-Kyung(hgrace7@dailypharm.com)
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