Licensing and Certification of Manufacturers

  5. Good Manufacturing Practice Certificate

Good Manufacturing Practice Certificate

Information on the different types of Good Manufacturing Practice (GMP) certificate application and requirements.

A GMP certificate is a hard copy certificate issued by the HSA attesting the compliance of a manufacturer with the applicable GMP standard following an inspection of the manufacturer conducted by the HSA.

GMP certificate for licensed manufacturers of active ingredients

Application for a GMP certificate is voluntary for a company that already holds a manufacturer’s licence for active ingredients. All licensed manufacturers are subjected to routine inspections by HSA. HSA does not automatically issue a GMP certificate after each inspection of a licensed manufacturer. Licensed manufacturers may apply for a GMP certificate without technical assessment in PRISM.

The GMP certificate contains details which include:

  • the certificate number
  • manufacturer’s name and site address
  • a description of the active ingredients and manufacturing steps inspected
  • the date of inspection
  • the expiry date, which could be up to 3 years from the date of inspection

GMP certificate for manufacturers of active ingredients used in products meant for clinical trials 

A company manufacturing active ingredients which are supplied solely for clinical trial use is not required to hold a manufacturer’s licence. They may voluntarily apply for a GMP certificate for HSA to conduct an inspection and assess if the manufacturing site is in conformity with the applicable GMP standard.

The application, inspection process and timeline for such an application are similar to the application for a new manufacturer’s licence.

Apply for a GMP certificate

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).

You may refer to the Guidance on Prism Application For Active Ingredient Manufacturer’s Licence And GMP Certificate1739 KB for step by step guide on how to complete the application form in PRISM

Note:
  • The GMP certificate is not renewable as it is a declaration of GMP compliance status at the time point following a satisfactory inspection outcome.
  • A GMP certificate cannot be amended once it has been issued. The validity of a GMP certificate is typically 3 years and the company will need to apply for a new GMP certificate before its expiry if the company wishes to continue the certification.

Additional copies

To request for additional hard copy of a GMP certificate, you can select the number of copies required under GMP certificate without technical assessment in PRISM.

Fees and turnaround time

 Refer to active ingredient licence and certificate fees and turnaround time for more information.
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