Assessments of overseas manufacturers

Since March 2001, all assessments of GMP evidence for overseas manufacturers carried out by the TGA GMP Audit & Licensing Section have been in accordance to the Standard of Overseas Manufacturer, 12th Edition (September 2000).

A number of issues have been identified resulting in assessments being rejected. The GMP Audit & Licensing Section would like to remind sponsors of the following:

• that the notary has sighted the original document, the evidence is current, the evidence indicates the scope or steps in manufacture and all certificates should be in English.
• products that are CE marked have current certificates indicating that the manufacturer complies with the requirements of Annex II (2) Section 3 or with the requirements of Annex V (5) Section 3., issued by a designated Notified Body, under the European Medical Device Directives.
• where there is a Mutual Recognition Agreement in place with a country (listed on page 4 of the Standard of Overseas Manufacturers 12th edition) - exporters, importers or manufacturers of medicinal products, are encouraged to request GMP certificates under the terms of the Agreement, from the relevant overseas regulatory agency.
• changes to existing manufacturing name, site, steps in manufacture or dosage form need to have the GMP evidence re-assessed. Sponsors should submit a request assessment of the overseas manufacturer by the GMP Audit & Licensing Section before notifying the relevant listing or registration section within the TGA of the changes.

Overseas GMP preclearance assessment checklist

To help streamline your Preclearance assessment of overseas manufacturers, please refer to the following checklist:

Overseas GMP Preclearance Assessment Checklist

• Sponsor details complete and correct
• Payment of assessment fee included if applicable
• Name of overseas authority and contact details included if applicable
• Manufacturer's name and manufacturing site address correct (and Enterprise number if known)
• Clear description of product type. For example, tablet, capsule or implantable device. Terms such as "pharmaceutical products" and "medical devices" are too broad and are not acceptable
• Box checked if the product is listable
• Box checked if product is sterile
• Relevant steps of manufacture stated

The evidence provided:

• Is from an organisation recognised by TGA
• Is an original or is properly notarised as a true copy of the original
• The name and address of the manufacturer is the same as that on the application form or Section 31 request
• The scope of the GMP evidence covers the products manufactured for supply to Australia and the steps of manufacture involved
• The evidence is current, i.e. has not expired
• A translation has been provided, if applicable