3. Ingredient Requirements
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3. Ingredient Requirements
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Ingredients Regulation Overview for Ingredient Manufacturers
Indonesia
This section provides the ingredient requirements for the product categories in scope.
3.1 Ingredients for Drug Products
3.1.1 Drug APIs
The Indonesian Good Manufacturing for Drugs (CPOB) aligns with the PIC/s GMP Guideline PE 009-014, July 2018, therefore GMP requirements for APIs are in accordance with internationally accepted regulations.
All suppliers of APIs must be qualified by the manufacturer.
The supply chain and traceability record for every active material (including for initial ingredients for the manufacture of active materials) must be available and stored by the drug product manufacturer.
For drug registration, the DMF is provided if available.
3.1.2 Drug Excipients
Excipients and excipient suppliers should be controlled appropriately 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
Annex 8 of Number 34 of 2018 regarding Guidelines for Good Manufacturing Practice for Drugs is essentially a copy of the ICH Q7 Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
Therefore, 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
Safety and quality requirements for both active substances must comply with the provisions in the Indonesian Pharmacopeia/Indonesian Herbal Pharmacopeia. If they are not regulated in either of these, reference can be made to the USP, BP, or pharmacopeia of other countries, or other international compendiums/standards, recognized scientific references, and/or scientific data.
Fulfillment of safety and quality requirements must be managed by implementing good manufacturing methods in accordance with the provisions of statutory regulations. These can align with drug, traditional medicine, or processed food GMP regulations.
Active ingredients derived from natural ingredients must be isolates, fractions, or extracts, or in the event they are not, they must be accompanied by the results of studies related to manufacturing technology, dosage, and benefits.
Manufacturers of health supplements in Indonesia must only use starting materials (active substances and excipients) purchased from qualified suppliers named in the relevant specification, with the supplier being adequately assessed and the result of this assessment recorded.
3.2.2 Health Supplement Excipients
Requirements for excipients are the same as for active substances.
3.2.3 Premixes
Pre-mixed ingredients for health supplements are permitted, provided they meet the safety and quality requirements outlined above.
3.3 Ingredients for Veterinary Medicines
Manufacture of veterinary medicines must be in accordance with Good Manufacturing Practices for Animal Drugs (CPOHB) (Decree of the Ministry of Agriculture No. 466/Kpts/TN.260/V/99), which aligns with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products. Therefore, the requirements for ingredients are the same as for human medicinal products.
Where a pharmacopeial monograph exists for an ingredient, compliance should be demonstrated. Accepted references for quality standards are:
- Farmakope Obat Hewan Indonesia (Indonesia Veterinary Medicine Pharmacopeia)
- Farmakope Indonesia (Indonesian Pharmacopeia)
- British Pharmacopeia (Veterinary)
- British Pharmacopeia
- United States Pharmacopeia
Veterinary premix is a category of veterinary drug in Indonesia (see Section 2.3); therefore care should be taken with using this term in relation to ingredients. If the premix of active substances from the ingredient supplier is further processed before supply to the consumer, it is still considered a raw material.
3.4 References
1. Regulation of the Indonesian Food and Drug Authority Number 34 of 2018 regarding Guidelines for Good Manufacturing Practice for Drugs
https://jdih.pom.go.id/download/product/1364/34/2018
2. Regulations of the Drug and Food Control Agency Number 24 of 2023 about Safety and Quality Requirements for Health Supplements
3. Guideline on Application of Veterinary Drug Registration
https://www.qia.go.kr/downloadwebQiaCom.do?id=23894
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