Random manufacturing without permission to change some items, false double preparation of manufacturing records, etc.
Establishment of’Pharmaceutical GMP Special Planning and Inspection Group’, year-round special monitoring, reinforcement of punishment, and system improvement
[팜뉴스=신용수 기자] The Ministry of Food and Drug Safety (Director Kang-rip Kim) announced the results of an administrative investigation conducted on the manipulation of documents for Binex and non-preservation pharmaceuticals.
According to the Ministry of Food and Drug Safety, as a result of an administrative investigation on Binex and non-preservative pharmaceuticals, violations of the Pharmaceutical Affairs Act, such as voluntary use of additives without permission to change, false double-writing of manufacturing records, ▲ unchanged manufacturing methods, and voluntary increase or decrease in raw material usage, were confirmed.
An official from the Ministry of Food and Drug Safety said, “I was concerned about the concealment and disposal of related documents during the administrative investigation process.” In the future, we will take serious administrative measures and other measures.”
The Ministry of Food and Drug Safety also inspected 29 consignment companies that manufacture and consign drugs with the same ingredients and formulations as the products that were confirmed to be violated by Binex and non-preservative pharmaceuticals. Regarding Binex, 24 companies and 32 items were inspected, and 5 companies related to non-preservative pharmaceuticals were reviewed.
As a result, it will confirm the violations of negligence in management and supervision of the consignee and take administrative measures, etc. However, as a result of direct inspection after collecting products with confirmed violations, it was determined that the content, etc., were within the test criteria, so there would be little harm to humans.
In addition, the Ministry of Food and Drug Safety checked 30 additional consignment and consignment factories nationwide to check similar cases with Binex and non-preservative pharmaceuticals.
As a result, no cases of violations identical to those of Binex or non-preservation pharmaceuticals were confirmed. However, measures such as administrative disposition will be taken after confirming that one site violates the pharmaceutical manufacturing and quality control standards. According to the Ministry of Food and Drug Safety, the company was found to have not carried out tests on finished products and raw materials, and that some of the product standards were not prepared. The manufacturing itself was carried out in accordance with the permission requirements, and there were no intentional offenses such as concealment or disposal.
On the other hand, the Ministry of Food and Drug Safety is planning to establish a’Pharmaceutical GMP Special Planning and Inspection Group’ to prevent the recurrence of intentional violations of manufacturing and quality control standards in the future to conduct irregular inspections on a regular basis. In addition, it plans to reinforce the inspection system for drug manufacturing and quality management, such as establishing and operating a reporting center for violations, and improving the effectiveness of penalties and improving the structure of the related permit system.
The above official said, “The Ministry of Food and Drug Safety will thoroughly and promptly conduct an investigation on Binex and non-preservation pharmaceuticals currently underway, disclose the results transparently, and take necessary measures.” “We will do our best to strengthen the level of drug safety management by actively promoting effective system improvement measures such as limiting the number of licensed items.”
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