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[Column] Some thoughts on good manufacturing practiceDr. Song's medbiz column
  • By Song Hyung-gon
  • Approval 2017.04.20 10:49
  • comments 0

In late February, I visited Ravensburg, Germany, to discuss the consignment production of medicinal products with Vetter, a contract manufacturing organization (CMO). The abbreviation refers to a specialized manufacturer of medicines which produce bio drugs on a consignment basis, and Vetter is an internationally renowned CMO that ranks among the global top 10 in this field.

In fact, most of the world-famous pharmaceutical companies, such as Pfizer, Roche, Johnson & Johnson and MSD, do not produce all of their drugs from beginning to end. Marketing a drug requires many stages, such as producing source materials, storing them in containers and packaging them, each of which is taken by what we call “professional players.” Vetter specializes in the aseptic filling of syringes, cartridges, and vials, and is manufacturing the products of the world’s leading drugmakers mentioned earlier on consignment.

You may be wondering why I traveled all the way to Germany to meet with a CMO when there are many good medicine manufacturers in Korea. True, the nation’s drug producing technology has reached quite a high level, not lagging far behind those of advanced countries seen from the aspect of manufacturing. For Korean pharmaceutical firms to conduct clinical trials and market their products in the United States and Europe, however, they should meet the production standards that suit the regulations they want. These standards are managed by the current Good Manufacturing Practice (cGMP), but unfortunately, there are few domestic pharmaceutical firms that have obtained the cGMP facility certifications.

The bio business part of GemVaxh plans to conduct the clinical trials of Alzheimer’s treatment in the U.S., so it had to find consignment production companies that fit the U.S. standards, and chose Vetter among them.

After visiting the Vetter factory and meeting with its staff, I realized that the nation’s pharmaceutical industry has a long way to go. Again, I can say with confidence that Korea’s medicine production has reached a pretty good level concerning technology alone. In reality, however, it still falls short of meeting a level that satisfies higher standards like cGMP. Hardware is important to reach these levels but far more important than that is the standing operating procedure (SOP). There is a joke that to have just a brush with the cGMP, one needs 10 billion won ($8.7 million). This is not just a story about the facility cost, though. As every step of production, starting from the warehousing of raw materials to the release of end products, has to exist in the form of documented regulations, it will require enormous costs to construct a system to meet such standards.

Vetter was a company that can meet cGMP standards, as each of its production stages has a perfect SOP. World-famous contract research organizations (CROs) say even the U.S. Food and Drug Administration has recognized the accuracy and safety of Vetter’s products. Its production costs are of course set at considerably high levels.

If Korea wants to globalize its pharmaceutical industry and create national wealth from it, the nation must first make its standards to match those of cGMP, and apply them to the entire pharmaceutical industry. The government ought to raise the standards of the Korea Good Manufacturing Practice (KGMP), and see that more than 400 pharmaceutical firms here follow those regulations. I think such a natural industrial restructuring is the path Korea should follow to protect people’s health and elevate the country to a global pharmaceutical power.

cprkings@gmail.com

<© Korea Biomedical Review, All rights reserved.>

An emergency medicine specialist, Song Hyung-gon served as head of the emergency department at Samsung Medical Center and vice president and spokesman of the Korean Medical Association. He is now the president of Bio Business at GemVax & KAEL. Contact him at cprkings@gmail.com.- Ed.

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