KGMP stands for Korea Good Manufacturing Practice. It is a set of regulations and guidelines established by the Ministry of Food and Drug Safety (MFDS) in South Korea to ensure that medical devices and pharmaceuticals are consistently produced and controlled according to quality standards. The main objectives of KGMP are to safeguard public health by ensuring that products are safe, effective, and of high quality.
Key aspects of KGMP include:
– Quality Management: Establishing a quality management system to oversee all aspects of production and control.
– Facility Requirements: Ensuring that manufacturing facilities meet specific standards for cleanliness, organization, and equipment.
– Documentation: Maintaining detailed records of all manufacturing processes, quality controls, and batch production.
– Process Control: Implementing rigorous controls and monitoring throughout the production process to prevent errors and ensure consistency.
– Personnel Training: Ensuring that all personnel involved in manufacturing are properly trained and qualified.
Compliance with KGMP is mandatory for manufacturers wishing to market their medical devices and pharmaceuticals in South Korea. It aligns with international standards like ISO 13485, ensuring that products meet both domestic and global quality requirements.
