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The Korea Pharmaceutical Test & Research Institute (KPTR) is a leading MFDS-designated inspection and testing body in South Korea. Established in 1992 under the Korea Pharmaceutical Traders Association, KPTR plays a critical role in ensuring the quality, safety, and efficacy of pharmaceuticals and related products through comprehensive testing and research services.

Mission and Accreditation 

KPTR’s core mission is to provide reliable, science-based testing services that support pharmaceutical quality assurance and regulatory compliance. The institute is officially accredited by the Ministry of Food and Drug Safety (MFDS) and recognized as a legal testing agency for pharmaceuticals, oriental medicines, cosmetics, and quasi-drugs.

In July 2017, KPTR obtained ISO/IEC 17025 certification, aligning its processes with international laboratory standards. This certification underscores KPTR’s dedication to technical competence and its commitment to producing accurate and traceable results in all testing procedures.

Historical Development 

KPTR has undergone significant development since its inception. It began operations in 1992 and, in 2008, became the first private domestic institution in Korea to establish a facility for bioequivalence testing. In 2012, it was renamed to its current identity, and in 2017, it relocated to a state-of-the-art facility in the Magok Industrial Complex in Seoul.

In 2020, KPTR completed ISO 17025 standard conversion and expanded its testing capabilities to include new service areas such as specialized analysis, preclinical testing, and bioequivalence studies.

Organization and Infrastructure 

KPTR’s organizational structure includes specialized departments staffed with highly qualified professionals in the fields of pharmaceutical chemistry, microbiology, pharmacology, and regulatory science. The institute is equipped with over 400 advanced testing instruments and facilities, such as HPLC, GC-MS, LC-MS/MS systems, and dedicated microbiological and animal testing laboratories.

These resources enable KPTR to handle a wide range of testing requirements, from routine quality control to complex clinical and preclinical studies.

Core Services 

KPTR provides a broad spectrum of testing and research services across various product categories, including:

  • Pharmaceuticals
  • Herbal and oriental medicines
  • Biologics and biosimilars
  • Cosmetics and quasi-drugs
  • Nutritional and health supplements
  • Bioequivalence studies
  • In vivo studies
  • Microbiological testing
  • Specialized analytical services

All services are conducted in compliance with MFDS regulations and, where applicable, international guidelines such as ICH, PIC/S, and OECD.

Regulatory Interface and Industry Role 

As a trusted testing partner for both domestic and international pharmaceutical companies, KPTR supports regulatory submissions by ensuring that test data meet stringent national and global standards. The institute also provides advisory services to aid in dossier preparation and regulatory strategy.

KPTR’s role contributes significantly to the development of safe and effective medicines, regulatory transparency, and the elevation of Korea’s global pharmaceutical standing.

Conclusion 

KPTR is a vital institution in South Korea's pharmaceutical landscape, providing accredited testing and research services essential for product quality, safety, and regulatory compliance. Its expertise in bioequivalence, microbiology, and specialized analysis makes it a trusted partner for pharmaceutical companies.

Need support with product testing or regulatory submissions in South Korea? Contact Freyr today for expert guidance.