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Health Sciences Authority

Good Manufacturing Practice certificate for local manufacturers

Find out how you can apply for the voluntary GMP certificate for local manufacturers.

Last updated 27 August 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

  • Medicinal Products (e.g. 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 (opens in new tab). 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

  • Therapeutic products

  • Chinese proprietary medicines

  • Medicinal Products (e.g. Medicated oils and balms)

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] (opens in new tab)

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:

Electronic Certificates

With effect from 30 June 2026, HSA will be issuing Good Manufacturing Practice Certificates and Good Distribution Practice Certificates as verifiable electronic documents using GovTech’s FileSG (opens in new tab) digital platform. There will not be any changes to the application process, regulatory requirements and application fees for these certificates. For further information, please refer to the HSA Frequently Asked Questions (opens in new tab).

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 (opens in new tab) or call 6776 0168 (from 7.00 am to midnight daily).