Unlimited entrusted livelihood and co-development system brought about the predicted disaster
The Ministry of Food and Drug Safety should check the quality of all factories and strengthen the quality management system.
[팜뉴스=김응민 기자] The Korean Pharmaceutical Association (Chairman Dae-eop Kim) is voicing intense criticism for the recent controversial follow-up measures by the Ministry of Food and Drug Safety in the case of Binex’s arbitrarily manipulating the amount of main raw materials and manufacturing methods of medicines.
The Korean Pharmacopoeia said, “The suspension of manufacturing and sales of six Binex medicines released by the Ministry of Food and Drug Safety and review of measures for generics for consignment production of these products is only a short-term measure.” We strongly urge you to face your anxiety and doubts and check the quality control of pharmaceutical products at all factories.”
“In CMO pharmaceutical companies specializing in consignment production of pharmaceuticals like Binex, manufacturing process control and quality control are the core of management, and it is the minimum moral obligation that pharmaceutical companies that produce pharmaceuticals.” It is a misunderstanding caused by the manufacturing process of synthetic drugs at the factory, and they are claiming that there is no problem with the consignment production of the Corona 19 vaccine.”
“Even though the situation is like this, many of the leading pharmaceutical companies in Korea who are entrusting the manufacture of drugs to Binex did not know at all. It shows the section of the Korean pharmaceutical industry, which is not busy in pursuit, without filtration, so it cannot be stopped.”
The Korean Pharmacist Society argued that this situation was not simply a problem of Binex companies, but that the KFDA’s responsibility was large, neglecting quality control, and regardless of the boulders of pharmaceutical companies.
The Korean Pharmacopoeia said, “It is very questionable whether the on-site investigation by the Ministry of Food and Drug Safety can be done to a level that will alleviate all suspicions, as Binex is reporting the destruction of documents to conceal the truth. Under the circumstances, it should be clarified that all 194 items consigned by Binex, as well as the generics for the consignment production of the first plant in Busan, of the 6 items already disposed of by the KFDA or the item under consideration for disposal are unreliable. “He said.
“This is a predicted tragedy brought about by the unrestricted entrusted livelihood and joint development system,” he said. “Pharmaceutical companies that give up quality control of medicines, a basic public good for public health, deserve to be expelled while in a hurry to make money.” .
In addition, “The Association urged the Ministry of Food and Drug Safety to redesign the consignment biotechnology/co-developed item permission system, including a full review of the GMP of domestic manufacturing plants and reinforcing the obligations of the product license holders very quickly so that this situation does not spread to mistrust over the overall pharmaceutical products. I strongly demand,” he added.
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