There are two types of routes of assessments:
1. GMP evidence evaluation / GMP Documentary Evidence Verification (DEVA)
Overseas manufacturers which have been previously audited and found to conform to Good Manufacturing Practice (GMP) standards by at least one Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) member authority may submit GMP evidence such as a valid GMP certificate, for evaluation. An on-site GMP audit is not required if the submitted evidence is found to be acceptable.
However, HSA reserves the right to conduct an on-site audit of an overseas manufacturing site, where deemed necessary. For example, audits may be conducted in cases where HSA has regulatory information or concerns regarding the GMP compliance of the overseas manufacturing site.
2. On-site GMP audit
Overseas manufacturers who do not meet the above criteria will be subjected to an on-site audit by our GMP auditors to assess their compliance to the HSA Guidelines on Good Manufacturing Practice for CTGTP.
An application to request for an overseas audit has to be filed.
Fees and turn-around-time
Refer to CTGTP fees and turn-around-time for more information.
How to apply
Download and complete the relevant application form:
Submit the completed form to:
Advanced Therapy Products Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
Level 11 Helios