3. Ingredient Requirements
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3. Ingredient Requirements
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Ingredients Regulation Overview for Ingredient Manufacturers
Thailand
This section provides the ingredient requirements for the product categories in scope.
3.1 Ingredients for Drug Products
3.1.1 Drug APIs
APIs (termed pharmaceutical chemicals) must be manufactured in accordance with an international or national GMP standard for producing pharmaceutical chemicals. The PIC/S Guide to Good Manufacturing Practice for Medicinal Products has been adopted by the Thai FDA and is the preferred standard for GMP.
In cases where the pharmaceutical chemicals are not regulated by the drug regulatory authority in the country of manufacture, other production quality certificates such as ISO and HACCP may be acceptable evidence of acceptable quality.
3.1.2 Drug Excipients
If excipients are not manufactured in accordance with the GMP for medicinal materials, the drug manufacturer should conduct a self-assessment of the facility’s compliance with good manufacturing practices. It should be stated in the drug registration dossier the principles and practical standards of good production practice that the excipient manufacturer meets. This is in line 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”.
3.1.3 Premixes
In accordance with the PIC/S GMP Principles, 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 of manufacture must be at least equivalent to the minimum requirements defined in the Annex of the Notification of the MoPH No. 420 of B.E. 2563 (2023). These are international or country-specific food GMP standards including:
- Good Hygiene Practices or HACCP (Codex Alimentarius International Food Standards)
- ISO 22000:2018
- BRC Global Standard for Food Safety
- International Food Standard.
They must also comply with pharmacopeial monographs (Thai or international).
3.2.2 Health Supplement Excipients
Health supplement excipients are classified as food additives, with standards according to the Codex Advisory Specification for the Identity and Purity of Food Additives or Announcement of the FDA according to the approval of the Food Committee. They must be of appropriate food-grade quality.
3.2.3 Premixes
The individual components of mixed excipients must each comply with the standards as described in 3.2.2 above.
3.3 Ingredients for Veterinary Products
Veterinary drugs have the same requirements for ingredients as human drugs, therefore the quality standards as described in Section 3.1 above are applicable. The Thai Pharmacopeia plus internationally recognized pharmacopeia such as the USP, BP, and WHO International Pharmacopeia are accepted references.
3.4 References
1. Drug Act B.E.2510 (1967) and its Amendments
2. Examples of Food Standard of Manufacturing Practices are equivalent to or not lower than the requirements prescribed in the Annex of the Notification of the Ministry of Public Health (Number 420) of B.E. 2563
https://food.fda.moph.go.th/media.php?id=529123641481371648&name=Ex_420_EN.pdf
3. Notification of the MoPH No. 281 B.E. 2547 (2004) Re: Food Additives
https://en.fda.moph.go.th/media.php?id=517782085918924800&name=No.%20281%20Food%20Additives.pdf
4. Codex General Standard for Food Additives (GSFA) Online Database
https://www.fao.org/fao-who-codexalimentarius/codex-texts/dbs/gsfa/en/
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