The Good Manufacturing Practice (GMP) certificate is a voluntary certification scheme to attest the manufacturing quality standards of the company. Manufacturers applying for the GMP certificate will be assessed for compliance to the HSA Guidelines on Good manufacturing practice (GMP) for CTGTP.
Manufacturers of CTGTP, investigational CTGTP, or active substances or starting materials used for the manufacture of CTGTP, may apply for the GMP certificate.
The GMP certificate is valid for 3 years from the date of assessment. Manufacturers are advised to apply for a new GMP certificate at least 3 months prior to the anticipated date for the GMP inspection to allow for sufficient time to schedule for a GMP inspection.
Changes to information on a GMP certificate which has been issued cannot be made. The company may choose to apply for a new certificate to include any changes in the details, if needed.
A manufacturer which has been GMP certified or licensed may request for a copy of the GMP certificate by submitting an application for a GMP certificate (without technical assessment).
Fees and turn-around-time
Refer to CTGTP fees and turn-around-time for more information.
How to apply
Submit your application through the relevant application form. Ensure you have the following before submitting your application: