About this guidance
This guidance is for TGA licensed or certified manufacturers and Australian sponsors of a medicine manufactured under the PIC/S Guide to GMP for medicinal products (PIC/S Guide to GMP). This guidance outlines:
- our interpretation of release for supply (RFS) of medicines in Australia
- your responsibilities related to RFS of medicines
- the role of an authorised person in RFS of medicines
We provide additional guidance on RFS requirements when releasing medicines manufactured at multiple sites.
RFS by an authorised person in Australia is different from the European system of batch certification by a Qualified Person. The European system is not adopted in the Australian manufacturing principles.
However, a Qualified Person meets the definition of an authorised person within the Australian regulatory framework.
All finished product batches manufactured according to the PIC/S Guide to GMP are required to comply with release for supply requirements.
Medicines that need to comply with RFS
This guidance on RFS applies to the following medicines:
- all medicines on the ARTG:
- listed medicine
- registered medicines
- export-only medicines
- medicinal gases - additional information available in Medicinal gas guidance - release for supply
- biological medicines - such as vaccines and biotechnology products.
- investigational medicinal products that are used in clinical trials in Phase 2 onwards.
- extemporaneously compounded medicines.
References in this guidance to market authorisation and ARTG entries do not apply to products that are exempt from inclusion in the ARTG, such as:
- investigational medicinal products (need to comply with the Product Specification File)
- compounded medicines
This guidance document is applicable to investigational medicinal products, subject to any difference in the legal provisions and more specific guidance in Annex 13 of the PIC/S Guide to GMP.
This guidance does not apply to:
- Medical devices
- the manufacture of active pharmaceutical ingredients (APIs)
- medicines prepared for initial experimental studies in human volunteers (Phase 1 clinical trials) as these are exempted from GMP
- products covered under the regulatory framework for biologicals; additional information is provided in manufacturing biologicals
- specific requirements for biological medicines under Official Control Authority Batch Release.
Development of this guidance
This guidance was developed in collaboration with industry and explains TGA’s interpretation and expectations for compliance with the release for supply requirements of the PIC/S Guide to GMP.
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).
Guidance documents are not intended to establish a minimum standard of practice for inspection purposes. Guidance documents are not enforceable.
Sections of PIC/S guide to GMP that apply to the RFS process
All relevant clauses of the PIC/S Guide to GMP apply to the manufacture of medicines. This document provides specific guidance regarding the interpretation of certain GMP requirements. Where we do not provide any commentary regarding interpretation, we expect the manufacturer to comply fully with those requirement(s), without further interpretational guidance.
In general, manufacturers should follow the principles of Part I of PIC/S guide, and in addition, all annexes relevant for release for supply and release for further processing to the next manufacturer in the supply chain.
Related guidance
Due to the range of medicinal products regulated in Australia and the detail required for different classes of products, additional guidance is provided for the following aspects that contribute to, or are related to, RFS:
- TGA interpretation and expectations for demonstrating compliance with PIC/S PE009-13
Understand our interpretation and expectations for compliance with specific sections of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13 - Medicinal gases
Understand our expectations for medicinal gas manufacture. - Product quality reviews (PQR)
For listed and complementary medicines, understand how to produce a PQR and your responsibilities. - Ongoing stability programs
For listed and complementary medicines, understand the requirements and your responsibilities for ongoing stability programs. - Risk classification for manufacturers
Understand how we classify levels of risk based on the manufacturing processes used at different sites and how this impacts our approach to inspection frequency.