Ministry of Food and Drug Safety “Binex·Non-preservation Pharmaceuticals, falsely write manufacturing records”

Binex and non-preservation pharmaceuticals have confirmed that some items have been arbitrarily manufactured, and manufacturing records have been duplicated. The Ministry of Food and Drug Safety has a policy to impose administrative dispositions on these pharmaceutical companies.

The Ministry of Food and Drug Safety announced the results of an administrative investigation conducted on Binex and non-preservative pharmaceuticals on the 25th.

Binex and non-preservation pharmaceuticals have confirmed violations of the Pharmaceutical Affairs Act, such as ▲random use of additives without permission for change ▲False double writing of manufacturing records ▲no change of manufacturing method ▲voluntary increase or decrease in raw material usage.

In particular, in preparation for the inspection by the Ministry of Food and Drug Safety, all processes from raw material weighing to completion of manufacturing were falsely written using the same format as the approved matter, and the records used in actual manufacturing were found to have been discarded after manufacture.

The Ministry of Food and Drug Safety checked 29 consignment companies that manufacture and consign drugs with the same ingredients and formulations as the products for which the violation was confirmed by Binex and non-preservative pharmaceuticals. I am going to do it.

In addition, in order to check cases similar to Binex and non-preservative pharmaceuticals, an additional inspection of 30 consignment and consignment manufacturing companies across the country did not confirm the same violations as Binex or non-preservative pharmaceuticals. After confirming the violation of the standards, the Ministry of Food and Drug Safety will take administrative measures and other measures.

The Ministry of Food and Drug Safety is planning to establish an’Excellent Pharmaceutical Manufacturing and Quality Control Standard (GMP) Special Planning and Inspection Group’ to establish a year-round unannounced inspection system in addition to regular monitoring of the current three-year manufacturing plant. Through this, it is planned to precisely check whether the manufacturer complies with manufacturing and quality control standards.

Along with this, the Ministry of Food and Drug Safety will also set up the’Clean Report Center for Drug Manufacturing and Quality Illegal Activities’ to operate an efficient year-round inspection system. We will operate a hotline (the KFDA website, phone, e-mail) from next month that allows all citizens to easily report intentional and illegal activities anonymously.

In addition, it is a policy to cancel the GMP conformity determination for illegal acts such as intentionally changing manufacturing methods and making false or double records. In addition, it plans to implement a plan to impose punitive penalties for unfair profits obtained through the violation. In addition, it also decided to raise the administrative disposition for non-compliance with the entrusted and trustees.

An official from the Ministry of Food and Drug Safety said, “We will actively pursue effective system improvement measures, such as improving management of pharmaceutical manufacturing methods and limiting the number of products permitted for foster care.”