GMP violation rate exceeds 20% every year for 5 years... 5 pharmaceutical companies that violated more than 10 times

Five pharmaceutical companies that violated more than 10 times... Top 20 cumulative total of 166 cases

Heo Jong-sik "Monitoring, disposition and follow-up management of repeat violators must be strengthened."

(Seoul = Yonhap News) Reporter Shin Seon-mi = As some pharmaceutical manufacturers are repeatedly violating manufacturing and quality management standards (GMP), it has been pointed out that there is a need to check the effectiveness of the management system.

According to data received from the Ministry of Food and Drug Safety by Rep. Heo Jong-sik of the Democratic Party of Korea on the Health and Welfare Committee of the National Assembly on the 16th, the GMP violation rate confirmed in regular and special pharmacist surveillance exceeded 20% every year for about five years from 2022 to June of this year.

GMP is a manufacturing and quality control standard to ensure the quality of pharmaceuticals from pharmaceutical manufacturing to quality control, testing, packaging, and shipment.

Looking at the violation rate by year, it rose from 37.9% in 2022 to 41.3% in 2023, then reached 33.1% in 2024 and 26.8% last year. The violation rate in the first half of this year is 22.7%.

A significant number of pharmaceutical manufacturers have been found to have violated the law several times over the past five years.

During this period, the 20 companies with the highest cumulative number of violations had a total of 166 violations, including quality control violations and non-compliance with standards.

There were five pharmaceutical companies that violated the standards more than 10 times over five years, and one company violated the standards 12 times.

As GMP violations continue, it is pointed out that there is a need to reexamine the management system for repeat violators.

Rep. Heo Jong-sik said, “We must completely inspect the monitoring, disposition, and follow-up management system for companies that repeatedly violate the law and strengthen management to prevent violations from recurring.”