About release for supply (RFS)
Release for supply is defined in the PIC/S Guide to GMP, clause 1.4 xv, as:
Certification by an authorised person 'that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products.'
Release for supply is:
- verification that all production and quality control testing records of a batch comply with Chapters 2 and 3 of the Therapeutic Goods Act 1989
- mandatory for medicinal products manufactured according to GMP
- the last manufacturing step
- a licensable step in manufacture within Australia
- performed through a legally valid signature of an authorised person
Australian RFS requirements
Before releasing any finished medicinal product for supply in Australia, an authorised person must certify that each batch has been manufactured and controlled in accordance with:
- marketing authorisation requirements, where applicable
- other regulations relevant to the production, control and release of the product.
For therapeutic goods with a marketing authorisation, do not take anything in this guidance as overriding the arrangements for the marketing authorisation.
Relevant authorisation and standards
RFS focuses on compliance with the following authorisations and standards:
- all aspects of the marketing authorisation, including:
- all details in the ARTG
- all other matters in relation to the marketing authorisation agreed in writing between the TGA and the Australian sponsor (e.g. variations to the ARTG entry, S14 Exemptions from compliance with a standard)
- for domestic manufacturers: the licence to manufacture therapeutic goods, including:
- the authorisations and conditions under the licence
- the steps in manufacture granted under section 38, Therapeutic Goods Act 1989
- conditions of licences as imposed under section 40, Therapeutic Goods Act 1989
- for overseas manufacturers: the TGA GMP certificate or GMP clearance(s), specifically their authorisations and conditions, as imposed under:
- sections 25(1)(g) and 26(1)(g), Therapeutic Goods Act 1989
- section 26A(3), Therapeutic Goods Act 1989
- the PIC/S Guide to GMP as specified in the current manufacturing principles.
- default standards under Section 10, Therapeutic Goods Act 1989
- all applicable Therapeutic Goods Orders (TGOs)
- all relevant GMP requirements, including assessing:
- Product Quality Reviews
- effectiveness of the on-going stability program
Scope of supply
Supply does not only consist of sale within Australia.
- sale within Australia
- other forms of supply within Australia, such as:
- free samples
- investigational medicines for use in phase 2 onward clinical trials
- export from Australia
Authorised person definition
An authorised person is a person recognised by the authority as having the necessary basic scientific and technical background and experience. Authorities identify who the authorised persons are through the manufacturer's pharmaceutical quality system.
Authorised person(s): an employee or employees authorised by a TGA approved manufacturer through a statement in the manufacturer's pharmaceutical quality system to perform release for supply. The person nominated to have control of quality control under section 37(1)(e), Therapeutic Goods Act 1989 would be an obvious choice to be an authorised person, but other arrangements can be considered, including delegation.