[이코노믹리뷰=곽예지 기자] The Ministry of Food and Drug Safety announced on the 25th that as a result of conducting an administrative investigation on manufacturing and quality of non-preservative pharmaceuticals with Binex (053030), a pharmaceutical company, it has confirmed violations of laws, such as the fact that drugs were manufactured arbitrarily without permission to change some products.
Previously, the Ministry of Food and Drug Safety confirmed that the two companies had illegally manufactured drugs, and conducted an emergency special inspection at 30 consignment and consignment drug manufacturing sites nationwide.
In preparation for inspection by the Ministry of Food and Drug Safety, all processes from raw material weighing to completion of manufacturing were falsely written using a manufacturing record in the same format as the licensed matter, and the records used for actual manufacturing were discarded after manufacture. In addition, it was confirmed that the amount of raw materials used was arbitrarily increased or decreased without changing the manufacturing method.
The Ministry of Food and Drug Safety also confirmed violations of negligence in management and supervision of the consignee by checking 29 consignment companies that consign drugs with the same ingredients and formulations as the products for which the violation was confirmed. These are 24 companies (32 items) entrusted to Binex and 5 companies (5 items) entrusted to non-preservative pharmaceuticals.
However, as a result of collection and inspection of these products, it was determined that the content, etc., were within the test standards, so there would be little harm to the human body.
In the future, the Ministry of Food and Drug Safety plans to conduct irregular inspections on a regular basis to prevent intentional violations. The’Pharmaceutical GMP Special Planning and Inspection Group’ is newly established as a dedicated organization. In addition to the regular monitoring of the current three-year manufacturing plant, it is planning to establish an unannounced inspection system throughout the year.
In addition, the’Clean Report Center for Drug Manufacturing and Quality Illegal Activities’ will be established to operate an efficient year-round unannounced inspection system. It is planned to operate a’hotline’ from April to allow all citizens to easily report intentional and illegal activities anonymously.
The company plans to strengthen penalties such as canceling the GMP conformity determination for illegal acts such as intentionally changing manufacturing methods and creating false or double records. Promote a plan to impose punitive penalties for unfair profits obtained through the violation. In order to strengthen the responsibilities of entrusted and consignees, the administrative disposition is also raised.
The Ministry of Food and Drug Safety said, “Concealment of related documents during the administrative investigation process.‧He said, “We are going to take serious administrative measures, etc.,” he said.