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Herbal Medicine

What is Facility Standard of Herbal Dispensaries?

Contents Descriptions
Facility Standard of Herbal Dispensaries A facility separately installed outside a medical institution and specializes in preparing herbal medicines, such as herbal medicines, pills, and plaster according to the prescription of an oriental doctor
Facility Standard of Herbal Dispensaries Certification It is mandatory to use only herbal medicines that meet the quality control standards of heavy metals and residual pesticides, so if the entire process of preparing herbal medicines, such as facilities, operation, and preparation, is evaluated according to September 2018 (valid period: 3 years) every 4 years.
Certification items: General herbal medicine certification is evaluated by 81 standard items that reflect KGMP and HACCP standards, including heavy metals, residual pesticide tests, etc., and 165 standard items such as clean zone setting, environmental management, sterilization process, etc

Authentication items are divided into regular and recommended items, and if both regular items are met, authentication will be possible.

Total items (Regular items: 9 areas / 30 sectors / 165 evaluation items) (Recommended items: 53 evaluation items): 218 items
  • Facility of Herbal Dispensaries
  • Clean zone management
  • management of workers
  • Management and
    organizational operations
  • Documentation Management
  • Continuous Quality Management
  • management of herbal medicines
  • Pharmacy management

What is herbal medicine GMP?

Herbal Medicine Herbal Medicine GMP certification
Facility Standard of Herbal Dispensaries All medicines and raw materials for the prevention and treatment of diseases based on the theory of oriental medicine such as plants, animals, and minerals obtained from nature
Facility Standard of Herbal Dispensaries Certification GMP certification for herbal medicines was introduced in June 2012. By the Ministry of Food and Drug Safety, GMP has been mandatory since January 2015, so that herbal medicines can be manufactured and sold only after obtaining approval for suitability.

In order to receive GMP certification of herbal medicine, it is necessary to manage facilities and environments, manage product and manufacturing, prepare and manage documents, prepare quality management, manufacture and packaging, store, store raw materials, and forwarding.