MFDS prepares a list of pre-requisite data for inspections

of overseas manufacturing plants

Efforts to improve administrative predictability and consistency after the regulatory innovation industry meeting

The Ministry of Food and Drug Safety has prepared a list of pre-requisite data for local inspections of overseas pharmaceutical manufacturing plants.

 

A total of seven data submission lists, including the list of drug manufacturing over the past three years, have been prepared to enhance the predictability and consistency of administration during field inspections of overseas manufacturing plants.

 

This list of data is one of the suggestions submitted by the pharmaceutical industry through the first meeting of the regulatory innovation industry in the pharmaceutical sector held in July last year.

 

At the time, the pharmaceutical industry requested that data should be prepared at the site of due diligence and submitted and reviewed during the due diligence process instead of submitting data in advance of the on-site inspection of overseas manufacturing plants.

 

The on-site inspection of overseas manufacturing plants is conducted in accordance with Article 695 of the Pharmaceutical Affairs Act, and specific procedures and methods are stipulated through the Prime Minister's Decree, but a detailed list of pre-requisite data has never been released.

 

In response, the Ministry of Food and Drug Safety decided to disclose a list of pre-required data by reflecting some of the pharmaceutical industry's suggestions instead of not submitting prior data.

 

According to the list of required data, ▲ List of pharmaceutical products (including manufacturing date, manufacturing number, shipment status, export volume, etc.), ▲ List of document management regulations and standards (including approval date and revision number), ▲ Comprehensive Process Validation Plan and Report (badge filling test, filter validation included), ▲ Quality Assessment Report (P) ▲ Manufacturing Material Report (Recent) For the last three years, the list except for the manufacturing list of medicines and the manufacturer's general list must be submitted only for items subject to field inspection.

 

The Ministry of Food and Drug Safety plans to finalize the list of pre-requisite data for overseas manufacturing plants in the future by collecting opinions from the pharmaceutical industry on the list.