Remote GMP inspections not recognized from April

in COVID-19 endemic

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.

 

In order to import active pharmaceutical ingredients (API), the company must submit a GMP certificate of API issued by the government or public institution of the country of manufacture.

 

However, when the company seeks to receive a supply of the APIs for the manufacture of finished pharmaceutical products, vendor audit results based on an on-site inspection of the finished pharmaceutical product manufacturer are also recognized as a GMP certificate.

 

Due to the COVID-19 pandemic, It had been difficult to conduct on-site inspections, which was why the MFDS had recognized written inspection result reports.

 

The MFDS stated, "During the COVID-19 pandemic, it was difficult to conduct on-site inspections, which was why we temporarily recognized written inspection reports.

 

However, with the end of the COVID-19 pandemic, we will give a 3-month grace period and then recognize only on-site GMP inspection reports from April." Previously, the MFDS had replaced GMP on-site inspections with remote inspections such as by reviewing PIC/S report data during the COVID-19 outbreak, but since September last year, it has been phasing out the flexibilities that were put in place and started on-site inspections for some items, new drugs, or aseptic preparations, conducting a phased transition back to on-site inspections.

 

As regulatory agencies such as the U.S.

 

and PIC/S have announced that non-face-to-face inspections cannot replace on-site inspections, the MFDS is also converting some parts of the non-face-to-face inspections back to on-site inspections.