The Ministry of Food and Drug Safety announced on the 29th that it will revoke the Good Manufacturing Practice (GMP) certification for solid dosage forms such as tablets and capsules produced by Korea Hutex Pharmaceutical Co., Ltd.
This is the first case since the GMP certification revocation system was implemented in December last year. GMP refers to the management standards required throughout all processes from product development to the shipment of finished products to ensure excellent pharmaceutical manufacturing. The revocation system was introduced to prevent cases where certified companies intentionally manufacture drugs illegally and falsify records related to GMP.
According to the Ministry, Korea Hutex Pharmaceutical arbitrarily increased or decreased additives during the manufacturing process of six products, including Recutin Tablets, Roxacin Tablets, Eddy Tablets, Jalnagel Tablets, Humosa Tablets, and Hutex AAP Tablets 325mg. However, the manufacturing records were falsely written as if they were produced according to the approved specifications. This was discovered during an on-site inspection of the company conducted by the Ministry in July.
Additionally, the Ministry plans to take administrative actions such as suspension of manufacturing operations under the Pharmaceutical Affairs Act for 64 products, including Grulis Tablets 2mg, which did not comply with the GMP standards at that time. The Ministry stated that it conducted internal reviews, external legal consultations, and expert meetings regarding the scope of the certification revocation before making this decision.
The Ministry emphasized that it hopes this action will serve as an opportunity for the pharmaceutical industry to voluntarily and thoroughly comply with GMP. It also plans to strengthen management of pharmaceutical GMP manufacturers to ensure that safe and high-quality medicines are manufactured and distributed in the future.
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