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

Overseas manufacturers who intend to register therapeutic products in Singapore may be subjected to a Good Manufacturing Practice (GMP) conformity assessment by HSA.

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.

Fees

Refer to GMP Conformity Assessment fees for more information.

How to apply

Download and complete the relevant application form:

Submit the completed form to:

Therapeutic Products Branch
Pre-marketing Division Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
Level 11 Helios
Singapore 138667

Refer to our Good Manufacturing Practice (GMP) guides for more details:

  • GMP Conformity Assessment of an Overseas Manufacturer (GUIDE-MQA-020) for more information on how to make an application.
  • Preparation of a Quality System Dossier (GUIDE-MQA-019)
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