Releasing medicines manufactured at multiple sites

About this guidance

If you are a sponsor or manufacturer of a medicine manufactured across multiple sites, then this guidance will help you understand:

• release for further processing (RFFP) requirements
• how RFFP fits into the release for supply (RFS) process.

Read this guidance together with the general requirements and responsibilities of release for supply of medicines, which apply to Australian sponsors and all TGA licensed or certified manufacturers.

On this page: Release for further processing (RFFP) | Development of this guidance | Content of this guidance | Related information

Release for further processing (RFFP)

RFFP refers to release of either:

• an intermediate or bulk product to the next manufacturer in the supply chain
• the finished product that requires alteration for distribution into the Australian Market.

Such arrangements are to be defined in GMP agreements.

Development of this guidance

We have developed this guidance to demonstrate how the release for supply process works across multiple sites of manufacture:

• in response to requests from industry for further guidance
• in consultation with experts from the relevant industry associations.

Scenarios to demonstrate RFFP and RFS

This guidance provides scenarios to help demonstrate some of the issues for consideration in order to meet the general RFS requirements, particularly for:

• specific areas of manufacture, for example listed and complementary medicines
• complex supply chains where manufacture occurs at multiple sites

Updating scenarios

This guidance is a living document. We can update it with scenarios that are more specific, where further interpretation is required. Any updates will only occur after appropriate consultation with the relevant stakeholders.

Intention

This information is provided for guidance only and has been developed on the basis of current knowledge of the subject matter. It should not be relied upon to address every aspect of the relevant legislation. Please also refer to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 for legislative requirements and the current version of the PIC/S Guide to GMP.

Disclaimer

This guidance is not mandatory or enforceable under law. It is not intended to be restrictive. We recommend following this guidance document to facilitate regulatory obligations being met. The guidance describes a way that a manufacturer may operate to demonstrate compliance with the relevant manufacturing principles (PIC/S Guide to GMP).

Content of this guidance

This guidance covers:

• how to meet RFS requirements when manufacturing at multiple sites, including:
  • Sponsor responsibilities
  • Sponsor and manufacturer – joint responsibility
  • Manufacturer responsibilties
  • RFS authorised person responsibilities
  • RFFP authorised person responsibilities
  • GMP agreements
  • RFFP documentation requirements
    • minimum RFFP documentation package
    • Certificate of Analysis
• scenarios to demonstrate release for supply when manufacturing at multiple sites:
  • Scenario 1 - RFS from secondary packaging site
  • Scenario 2 - Two consecutive RFS steps.

For information on release for supply of medicinal gases, refer to the medicinal gas guidance

Related information

Related information:

• PIC/S Guide to GMP Part II: RFFP of active pharmaceutical ingredients and intermediates Section 6.7 Batch production record review