As one of the biggest pharmaceutical markets in Asia, Korea has a relatively well-developed, high quality medical system. When registering medical devices and pharmaceuticals in Korea, manufacturers must follow Korean Good Manufacturing Practice (KGMP) standards, which are similar to international standards for quality management systems (ISO 13485).
Pacific Bridge Medical’s experts can advise your medical company on KGMP and quality management in Korea, ensuring compliance with all Korean and international quality standards.
KGMP AND KOREA QUALITY MANAGEMENT FOR MEDICAL DEVICES
In Korea, companies producing Class II, III, and IV medical devices must acquire a KGMP certificate before they can submit a new device application. ISO 13485 certificates do not replace Korean GMP certificates.
Companies should apply for KGMP certificates through third party auditors. The Medical Device Quality Management Team of the Ministry of Food and Drug Safety (MFDS) conducts on-site inspections to verify compliance. A third party auditor may help the MFDS with their inspections. Most Class II devices will only undergo third party inspections. According to the MFDS, importers rather than manufacturers are responsible for quality assurance.
As of 2015, companies must undergo KGMP auditing at the beginning of product registration, rather than after the product is approved by the MFDS. Furthermore, in vitro diagnostic (IVD) products are now regulated as medical devices instead of pharmaceuticals. IVD manufacturers must therefore comply with KGMP requirements as well.
KGMP AND KOREA QUALITY MANAGEMENT FOR PHARMACEUTICALS
In the past, Korea’s pharmaceutical GMP standards were significantly less rigorous than those in Japan, Europe, and the United States. However, over the past decade, KGMP drug regulations have become increasingly harmonized with international standards for validation, change control, and product review, among other areas.
New drug GMP compliance certificates are valid for three years from the day they are issued. Extended drug GMP certificates are valid for three years from the day of a GMP inspection. However, if a GMP assessment takes place because of changes to a product, the expiry date of the certificate is not affected.
Revalidation of drugs is required in the event of a change in ingredients and/or preparation. Products that are either already part of Korea’s Pharmacopeia, included in the official compendia approved by the Ministry of Food and Drug Safety (MFDS), may receive an exemption from analytical validation requirements. The same is true for drugs that have identical dosage forms and testing methods to products that were already validated, but have different quantities of active pharmaceutical ingredients (APIs).
For process validation, prospective validation is standard. However, in the case of orphan drugs, drugs that are produced in very small numbers, narcotics, and other products specifically listed by Korea’s Ministry of Health and Welfare (MOHW), concurrent validation may be possible. Additionally, it may be possible to obtain an exemption from process validation for non-sterile pharmaceutical products that are basically identical to products that have already been validated in terms of dosage, APIs, and manufacturing systems, among other factors.
The KGMP standards for manufacturing sterile products closely follow the guidelines laid down by the World Health Organization (WHO), though they are not quite as detailed as WHO’s guidelines. These guidelines are themselves based on the ISO-14644-1 cleanroom standards.
For a free consultation on your KGMP and quality management needs in Korea, contact us today.
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