Good Manufacturing Practice certificate for local manufacturers
Find out how you can apply for the voluntary GMP certificate for local manufacturers.
Last updated 30 April 2026
Overview
Good Manufacturing Practice (GMP) certification is a voluntary scheme offered to local manufacturers of the following products, interested to be certified for conformity with relevant GMP standards by us:
Therapeutic products
Chinese proprietary medicine
Active pharmaceutical ingredients
Cosmetic products
Medicated oils and balms
To apply for a GMP certificate, you must be authorised by your company to do so as the person responsible, such as managing director, QA/QC manager or production manager.
GMP certification audit
After our GMP auditors have completed the GMP certification audit and find that your company has demonstrated satisfactory compliance with the required GMP standard, we will issue the certificate in the name of your company as registered with the Accounting and Corporate Regulatory Authority. The scope of certification is normally determined by the scope of the actual audit that was performed at the manufacturing facility and the types of dosage forms or range of products being manufactured.
A GMP certificate is valid for three years from the date of assessment and cannot be renewed or amended. Upon expiry, you will need to submit a new application if you are still interested in re-certification. GMP audits will apply.
List of GMP standards
Products manufactured | GMP standard used to conduct the certification audit |
|---|---|
| Please refer to HSA | Good Manufacturing Practice and Good Distribution Practice Standards |
Active pharmaceutical ingredients | Please refer to HSA | Good Manufacturing Practice and Good Distribution Practice Standards |
Cosmetic products | GMP Guidelines for Manufacturers of Cosmetic Products [PDF, 224 KB] |
Documents required
A Site Master File must be attached in the application. For information on the preparation of a Site Master File, refer to the relevant guidance notes:
Guidance Notes for Pharmaceutical Manufacturers on Preparation of a Site Master File (for therapeutic products, chinese proprietary medicine, active pharmaceutical ingredients)
Guide for Preparation of a Site Master File for a Manufacturer of Cosmetic Products [PDF, 163 KB] (for cosmetic products)
Fees and turn-around-time
Refer to Certification fees and turn-around-time for more information.
How to apply
Submit your application through PRISM. Ensure you have the following before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).