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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

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Step 1 - Understanding your supply chain and establishing agreements

Modern supply chains can be complex with multiple manufacturing sites performing various steps of manufacture of a product. You need to:

  • understand the activities of every manufacturer in the supply chain of your product
  • establish and maintain the relevant GMP, quality or technical agreements with whom you have a direct relationship with, including subsidiaries of the same parent company:
    • The principles of GMP require you to have a GMP, quality or technical agreement with the primary or principle manufacturer of the medicine that clearly outlines the roles and responsibilities for each party
    • Where these manufacturers use subcontractors, this should be clearly specified in the agreement (for example, outsourced testing laboratories).

GMP, quality or technical agreements should be in place between the primary or principle manufacturer and their subcontractors. This should be provided as part of your application where appropriate.

A typical global supply chain

The diagram below illustrates an example of a typical global supply chain and aims to clarify the GMP, quality or technical agreements that need to be in place for the supply of medicines to Australia.

This diagram does not cover every scenario and if you have questions in relation to GMP, quality or technical agreements please contact us prior to proceeding with your application.

The Australian Marketing Authorisation (MA) holder (the sponsor) has a direct relationship with the primary or principle manufacturer of the product. This relationship consists of a two way communication flow and signed GMP, quality or technical agreement. In addition, the primary manufacturer has a supply chain and contracted manufacturing sites, such as, the API supplier, contract testing lab, contract steriliser, contract secondary packager and contract Authorised Person (AP) performing release for supply.

A typical global supply chain - Description: The Australian marketing authorisation holder (the sponsor) has a direct relationship with the primary manufacturer of the product. This relationship consists of a two way communication flow and signed GMP/Quality or technical agreement. In addition, the primary manufacturer has a supply chain and contracted manufacturing sites, including the API supplier, contract testing lab, contract steriliser, contract secondary packager and contract Authorised Person (AP) performing release for supply.

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