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Regulator to inspect 12 biopharmaceutical plants overseas
  • By Lee Hye-seon
  • Published 2019.02.20 16:18
  • Updated 2019.02.20 17:20
  • comments 0

The Ministry of Food and Drug Safety said it would conduct a regular inspection on 12 biopharmaceutical factories overseas that supply medicines for drugmakers in Korea.

Kim Young-lim, director at the pharmaceutical standardization division at the National Institute of Food and Drug Safety Evaluation under the ministry, announced the plan at a government briefing on policies, approval, and licensing on biopharmaceutical products on Tuesday in Seoul.

The 12 factories supply drugs for Scigen Korea, GC Pharma, Kyowa Hakko Kirin Korea, Roche Korea, Johnson & Johnson Korea, Medical, Glovax, Lilly Korea, Korea Vaccine Corp., MSD Korea, Daewoong Pharmaceutical, and Novo Nordisk Korea.

The ministry selects overseas plants for regular inspections considering their impact on the domestic market such as annual inspection history, quality problems, and import earnings.

After reviewing submitted data, the ministry evaluates the hazard level of the factory as high, medium and low. The ministry decides the number of inspectors and the inspection period according to the evaluation results.

Factories with the high hazard level will receive a five-day inspection by three inspectors, those with the medium, four to five days by two or three persons, and those with the low, four days by two persons.

The companies operating the plants must submit Site Master File, the history of regulatory inspections in the past three years, product quality reports, and management data on significant changes, at least two months before the scheduled review.

Essential inspections include compliance with pharmaceutical regulations such as those on manufacturing and quality, any harmful factors such as the plant’s impact on the human body and product quality. Inspectors will focus on checking sterility/sterilization validation, annual quality evaluation, and change/deviation management.


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