Daewoong Osong Plant Leading with 'Smart' Passes Brazil GMP Inspection with 'Flawless' Record

Daewoong Pharmaceutical's Osong Smart Factory has flawlessly passed the stringent inspection by Brazil's National Health Surveillance Agency (ANVISA).

Panorama of Daewoong Pharmaceutical Osong Plant in Cheongju, Chungbuk [Photo by Lee Chunhee]

Daewoong Pharmaceutical announced on the 1st that it recently received a certification result of "Zero Observation" in the Good Manufacturing Practice (GMP) inspection conducted by ANVISA on the Osong Smart Factory, which produces the new drugs 'Pexuclu' and 'Enblo,' for their new approvals.

The inspection took place over four days starting from the 4th of last month at the Osong Smart Factory. It is explained that ANVISA's GMP audit is known to be as stringent and challenging as the U.S. Food and Drug Administration (FDA)'s cGMP. Through this flawless passage of Brazil's GMP, Daewoong Pharmaceutical plans to accelerate its entry into the Latin American market. Pexuclu, a new drug for gastroesophageal reflux disease, is currently undergoing the Brazilian approval process with a target launch next year. The diabetes drug Enblo is preparing for its Brazilian approval application.

Daewoong Pharmaceutical cited the smart factory as the key factor for passing the flawless inspection. The Osong factory is a smart factory certified at Level 4 out of 5 by the Smart Manufacturing Innovation Promotion Group under the Ministry of SMEs and Startups. This is just one step below the highest Level 5, meaning it is capable of preemptive responses and optimized decision-making through simulation, and if there are no errors or process changes, most processes require no human intervention.

Central Control Room of Daewoong Pharmaceutical Osong Plant in Cheongju, Chungbuk. True to the concept of a smart factory, there are no personnel stationed in the control room under normal circumstances.
[Photo by Daewoong Pharmaceutical]

The same applies to data as well as production. Under the paperless factory concept, manufacturing test records and all logs are automatically recorded and managed, enabling real-time monitoring and control of the process status while ensuring data cannot be tampered with. Through this, the data integrity was proven during the ANVISA inspection process, facilitating a smooth audit. Lee Seung-ha, Head of Production Headquarters and Osong Factory Manager at Daewoong Pharmaceutical, stated, "We have a system where data modification or alteration is impossible," adding, "Through the smart factory, we have successfully passed domestic and international inspections in terms of quality, and productivity indicators have improved by 40%."

Daewoong Pharmaceutical plans to actively pursue GMP certifications in major global markets such as the U.S. and Europe, leveraging this smart manufacturing process. Seung-ho Jeon, CEO of Daewoong Pharmaceutical, said, "We will continue to develop the Osong factory into a Level 5 smart factory," and added, "Furthermore, by making the Osong factory an advanced base for innovative new drugs, we aim to achieve Pexuclu's entry into 100 countries by 2027 and Enblo's entry into 50 countries by 2030."

This content was produced with the assistance of AI translation services.