Sponsor and manufacturer - joint RFS responsibility

The PIC/S Guide to GMP identifies shared responsibilities between the sponsor (marketing authorisation holder) and the manufacturer, including:

• ability to recall a batch
• GMP agreements
• ongoing stability data and updates
• product quality reviews
• provide authorised person(s) access to information.

Ability to recall a batch

A system needs to be available to identify and recall any batch of medicine from sale or supply without delay, for all products that could be rendered hazardous by a quality defect in the batch.

GMP Agreements

Sponsors and manufacturers are required to establish valid GMP agreements, in accordance with the PIC/S Guide to GMP, including:

• clearly establishing responsibilities for all GMP related activities
• specifying how the RFS authorised person ensures that each batch has been manufactured and checked for compliance with the marketing authorisation, where applicable.

Where multiple manufacturers are involved in the manufacture of a product, there are additional details regarding the contents of GMP agreements (including ongoing stability and product quality review arrangements) in:

• Releasing medicines manufactured at multiple sites

If the multiple manufacturers are part of one organisation and are covered by the same corporate quality system, responsibilities for RFS could be clearly defined within the corporate quality system, instead of having separate GMP agreements between sites.

Ongoing stability

The RFS manufacturer and, where different, the sponsor, are responsible for ensuring:

• an on-going stability program is performed
• the on-going stability results are reviewed to monitor product stability
• the ongoing stability results are provided promptly to the authorised person that performs RFS

Related guidance on ongoing stability

We cover the principles of conducting ongoing stability studies in:

• TGA interpretation and expectations for demonstrating compliance with PIC/S PE009-13

For listed and complementary medicines, additional guidance is available:

• Ongoing stability testing for listed and complementary medicines
• Sunscreen manufacturing, Demonstrating compliance with the PIC/S guide to GMP, PE009-13

Product quality reviews

The manufacturer and, where different, sponsor (market authorisation holder), are responsible for ensuring:

• the PQR is performed and prepared in a timely manner, and is accurate
• the PQR results are reviewed and evaluated to assess if corrective and preventive actions, or any revalidation, should be undertaken under the PQS

Related guidance on PQRs

We outline the expectations of all manufacturers of medicines to generate PQRs in accordance with GMP requirements, in:

• TGA interpretation and expectations for demonstrating compliance with PIC/S PE009-13

For listed and complementary medicines, additional guidance is available:

• PQRs for listed and complementary medicines

Provide authorised person(s) access to information

The manufacturer and, where different, sponsor, are responsible for ensuring the authorised person(s) responsible for RFS have full access to:

• all aspects of the marketing authorisation, including details in the ARTG and other matters agreed on in writing between TGA and the Australian sponsor
• all relevant aspects of the manufacturers and manufacturing steps:
  • for TGA-licensed manufacturers:
    • the licence to manufacture therapeutic goods
    • all authorisations and conditions under the licence
    • the steps in manufacture granted under section 38, Therapeutic Goods Act 1989 and conditions of licences as imposed under section 40, Therapeutic Goods Act 1989
  • for overseas manufacturers:
    • the TGA GMP certificate and GMP clearances
    • all authorisations and conditions, as imposed under sections 25(1)(g), 26(1)(g) and 26A(3), Therapeutic Goods Act 1989
  • the PIC/S Guide to GMP as specified in the current manufacturing principles
  • default standards under section 10 of the Therapeutic Goods Act 1989
  • all applicable Therapeutic Goods Orders
• relevant batch certificate of analysis
• complete and reviewed PQRs
• ongoing stability data and updates
• significant batch deviations
• approved artwork specifications
• significant changes to manufacturing processes and ongoing validation:
  • product release and expiry specifications
  • marketplace feedback or signals
  • complaints, recalls, adverse events
  • supply chain details and approved manufacturers and suppliers (all contracts)
• Transport arrangements and any transport data that is available