3. Ingredient Requirements
- 3 Mins to read
- DarkLight
3. Ingredient Requirements
- 3 Mins to read
- DarkLight
Article summary
Did you find this summary helpful?
Thank you for your feedback
Ingredients Regulation Overview for Ingredient Manufacturers
Malaysia
This section provides the ingredient requirements for the product categories in scope.
3.1 Ingredients for Drug Products
3.1.1 Drug APIs
The manufacture of drug APIs must be compliant with Good Manufacturing Practices in line with PIC/S, WHO, or other drug regulatory authority guidelines.
In case an atypical API (e.g. excipient, food additive, cosmetic ingredient) is used as an API, if the above GMP compliance evidence is not required as long as the ingredient supplier is controlled through the drug product manufacturer’s quality management system and the manufacturer makes a declaration to this effect.
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, 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
Premixing of APIs is considered by the NPRA to be part of the product manufacturing process, and it is stated that information on premixed API should be submitted under Part II-P of the registration dossier. Therefore, a manufacturer performing API premixing is considered to play a role in the drug product manufacturing process.
3.2 Ingredients for Health Supplements
3.2.1 Health Supplement Active Substances
Active ingredients in health supplements must be listed within the NPRA database. If it is not listed, documentation must be submitted to support the ingredient’s safety and dose in health supplements.
According to the Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements, starting materials used in health supplements should be manufactured in accordance with GMP. If the product is classified as food in its country of manufacture, a GMP certificate of food standard issued by the relevant country authority will be accepted on the condition that the standards are similar to those practices in Malaysia.
3.2.2 Health Supplement Excipients
Quality requirements as per active ingredients.
3.2.3 Premixes
Since the premixing of ingredients is considered part of the manufacturing process, this step must comply with GMP. The accepted standards of GMP are determined by the category of the product in the country of origin (e.g. if the product is classified as food, a GMP certificate of food standard issued by the relevant country authority will be accepted on the condition that the standards are similar to those practices in Malaysia).
3.3 Ingredients for Veterinary Products
3.3.1 Ingredients in NPRA Registrable Products
The NPRA’s GMP Guidelines for Veterinary Products state that manufacturers of veterinary products should comply with the same standards as manufacturers of human medicinal products. Therefore the PIC/S GMP Guide Part 1 (Basic Requirements for Medicinal Products) and Annex 4 (Manufacture of veterinary medicinal products other than biologicals) should be applied to ingredients for veterinary products.
See Section 2.3 for the definition of a veterinary premix. The Guideline on GMP for Veterinary Premixes applies to veterinary premixes for medicinal purposes. This states that starting materials should be sourced from suppliers who can demonstrate compliance with a quality assurance system, therefore evidence of compliance is required from ingredient suppliers providing ingredients for the manufacture of veterinary premix.
If the ingredient supplier is producing the premix for supply as a finished product, they must be able to demonstrate evidence of compliance with a GMP quality management system, which meets the requirements of the Guideline on GMP for Veterinary Premix.
3.3.2 Ingredients in NPRA Non-Registrable Products
Products such as feed additives and veterinary health supplements without therapeutic claims are regulated by the Department of Veterinary Services, with control defined by the Feed Act 2009. The Good Manufacturing Practice for Feed defines the requirements, which are in line with international food safety regulations such as Codex Alimentarius.
3.4 References
1. Drug Registration Guidance Document Third Edition, Seventh Revision January 2024. Appendix 11- Regulatory Control of Active Pharmaceutical Ingredients (APIs)
2. Drug Registration Guidance Document Third Edition, Seventh Revision January 2024. Appendix 6- Guideline on the Registration of Health Supplements
3. Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements
4. Guidelines for Veterinary Medicine
https://www.npra.gov.my/index.php/en/guideline-for-veterinary-medicine
5. GMP Guidelines for Veterinary Products
6. Guideline on GMP for Veterinary Premixes First Edition January 2015
7. Good Manufacturing Practice for Feed
https://www.dvs.gov.my/dvs/resources/auto%20download%20images/PDF/Good_Manufacturing_practice_23_10_(2).pdf
Was this article helpful?