Good Manufacturing Practice (GMP) conformity assessment of overseas manufacturers of therapeutic products

Overview

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 PIC/S Guide to GMP for Medicinal Products.

An application to request for an overseas audit has to be filed together with the submission of a Quality System Dossier, which is a set of documents and information that provides a comprehensive overview of the:

• Manufacturing site.
• Site facilities.
• Quality system of the manufacturing operations.