Manufacturer RFS responsibilities

In addition to ensuring manufacturing is compliant with any marketing authorisations, all RFS manufacturers, both in Australia and overseas, are responsible for the following:

• Traceability of each batch
• Appointing authorised person(s)
• Pharmaceutical quality system (PQS)
• Shared responsibilities with the sponsor
  • Ability to recall a batch
  • GMP agreements
  • Provide authorised person(s) access to information

Overseas manufacturers can perform release for supply, provided certain conditions are met.

Related guidance on manufacturing

Australian manufacturing licences and overseas GMP certification
A step-by-step guide for Australian manufacturers wanting to apply for a manufacturing licence and overseas manufacturers inspected by TGA

Manufacturing medicines and biologicals for use in a clinical trial
This guidance is part of the Australian clinical trials handbook and explains the requirements of both local and overseas manufacturers producing medicinal products for use in clinical trials.

Releasing medicines manufactured at multiple sites
Additional information on GMP requirements when releasing products manufactured at multiple sites.

Traceability of each batch

Ensure documentation provides traceability of each batch according to the basic requirements of GMP including records of manufacture which:

• demonstrate all required steps were performed and that the quantity and quality of the product was as expected
• fully record any significant deviations, including investigation and appropriate corrective and preventive actions implemented
• enable the complete history of a batch to be traced by being retained in a comprehensible and accessible form

Review the batch records to ensure that the release for supply site and authorised person are identifiable when the product ARTG entry allows more than one release for supply site.

Appointing authorised person(s)

RFS authorised persons are key personnel (clause 2.5, Part 1, PIC/S Guide to GMP) and may be:

• the person(s) nominated to have responsibility for quality control by an Australian manufacturer under section 37(1)(e), Therapeutic Goods Act 1989
• another specified person, or a delegate

A manufacturer may have more than one authorised person for RFS:

• all authorised persons:
  • should have the necessary qualifications and practical experience
  • would normally be full-time personnel
• each manufacturing site (whether in Australia or overseas) must have at its disposal the services of at least one authorised person (for RFFP and/or RFS)

In the PQS, you are to clearly document and explain the authorised person's job functions and training relating to release.

Pharmaceutical quality system (PQS)

Your PQS is to be compliant with the PIC/S Guide to GMP and needs to include:

• detailed release procedures
  • if computer systems are used to record RFS decisions, take note of Annex 11 of the PIC/S Guide to GMP
• details of the authorised person(s) responsible for release for supply
• training arrangements that ensure the authorised person:
  • has a level of education and expertise appropriate for the steps in manufacture for which responsibility is taken
  • is proficient in the release for supply requirements of the PQS
  • has appropriate knowledge for the specific steps in manufacture for which responsibility is taken
  • keeps their knowledge up-to-date in light of:
    • technical and scientific progress
    • changes in quality management relevant to the release that they authorise

Overseas manufacturers

We recognise release for supply by an authorised person located at an overseas manufacturer, provided all of the following conditions are met:

• the manufacturing steps performed are covered by a current TGA GMP certificate and/or GMP clearance(s), specifically their authorisations and conditions, as imposed under sections 25(1)(g), 26(1)(g) and 26A(3) of the Therapeutic Goods Act 1989
• responsibilities for RFS are clearly defined in either:

  • a GMP agreement between the contract giver (which can be the sponsor or a manufacturer) and the contract acceptor (RFS manufacturer)

    OR, if both are part of one multinational organisation and are covered by the same corporate quality system:

  • an arrangement within the corporate quality system
• nominated in the ARTG entry that RFS is being performed by the overseas manufacturer

Our GMP clearance guidance outlines details regarding overseas manufacturer's responsibilities.

We assess and verify release for supply arrangements with overseas manufacturers through either:

• an on-site GMP inspection
• the compliance verification process (except when compliance verification is based on evidence from MRA regulators in their own country)

We assess:

• the GMP agreement(s) with the contract givers
• the RFS procedures including marketing authorisation requirements