3. Ingredient Requirements

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Ingredients Regulation Overview for Ingredient Manufacturers
South Korea

This section provides the ingredient requirements for the product categories in scope.

3.1 Ingredients for Drug Products

3.1.1 Drug APIs

The MFDS has adopted the ICH Q7 GMP Guide for Active Pharmaceutical Ingredients (included as Annex 15 of the Regulation on Good Manufacturing Practices (GMP) for Medicinal Products), therefore the quality requirements for APIs align with these internationally accepted GMP regulations.

Where a recognized pharmacopeial monograph exists, the ingredients should comply with the standards defined. Official compendia/pharmacopeia recognized by MFDS besides the Korean Pharmacopeia are:

USP-NF
Japanese Pharmacopeia
British Pharmacopeia
European Pharmacopeia
Deutches Arzneibuch (Germany)
Pharmacipee Francaise (France)

3.1.2 Drug Excipients

Excipients and excipient suppliers should be controlled appropriately by drug product manufacturers based on the results of a formalized quality risk assessment in accordance with the PIC/S Guideline PI 045-1 ‘Guidelines on the formalized risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use’ or other related international guidelines.

3.1.3 Premixes

In accordance with ICH Q7, the API manufacturer should designate and document the rationale for the point at which production of the API begins and from this point on, appropriate GMP should be applied.

3.2 Ingredients for Health Supplements

3.2.1 Health Supplement Active Substances

The standards and specifications of ingredients approved as functional ingredients in health functional foods are defined by the Functional Health Foods Act. Vitamins are approved with appropriate standards for each defined in the Health Functional Food Code. They must be manufactured with appropriate standards of GMP for food grade ingredients.

3.2.2 Health Supplement Excipients

Health functional food excipients are termed ‘other ingredients’ and must meet the Food Code or Food Additives Code standards.

3.2.3 Health Supplement Premixes

Where two or more functional ingredients are combined, the specifications of the individual ingredients will apply, and in case of overlapping specifications, the stricter specification will apply. It must be verified that the safety and health benefits of the individual ingredients are maintained.

The individual components of an excipient premix (termed “Mixed Preparation”) must all be listed in the Food Additives Code, and each much comply with the individual specifications. The manufacturing method must not cause any change to the original components.

3.3 Ingredients for Veterinary Products

Manufacture of veterinary products should be compliant with the Korean Veterinary GMP, which is in accordance with the WHO GMP for medicinal products. Therefore, requirements for ingredients used in veterinary products are the same as for human medicines.