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Manufacture of sterile radiopharmaceuticals labelled with fluorine-18
About this guidance
This guidance is for TGA licensed manufacturers of positron emission tomography (PET) sterile radiopharmaceuticals labelled with fluorine-18, and is about the application of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009 (PIC/S Guide to GMP).
While this guidance is intended for TGA licensed manufacturers of sterile radiopharmaceuticals labelled with fluorine-18, it may also be of use to manufacturers who:
- are exempt from the requirement to hold a TGA licence to manufacture under Schedule 8 of the Therapeutic Goods Regulations 1989
- manufacture sterile radiopharmaceuticals labelled with fluorine-18
The scope of this guidance only applies to radiopharmaceuticals that are:
- labelled with fluorine-18 [18F] (which has a short half-life)
- used as radiotracers for diagnostic imaging
- synthesised using cassette-based methodology, with cassettes and their reagents being supplied intact, as a kit (pre-assembled, low-bioburden, and ready for use) by qualified suppliers
- manufactured in small batches and small volumes, typically <50mL
- produced as a sterile finished good for parenteral use
The TGA has adopted the PIC/S Guide to GMP, as the manufacturing principles for the manufacture of medicines, including sterile radiopharmaceuticals.
This guidance explains TGA's interpretation and expectations for compliance by TGA licensed manufacturers of sterile radiopharmaceuticals labelled with fluorine-18 with the PIC/S Guide to GMP. This guidance document provides specific interpretation of PIC/S clauses, and how compliance may be met. Where no specific guidance is provided, full compliance with the requirements of the PIC/S clause(s) is expected.
Comply with the requirements of the marketing authorisation unless the medicine you manufacture is exempt from Part 3-2 of the Therapeutic Goods Act 1989.
In all cases, default standards apply to the manufacture of radiopharmaceuticals as defined under the Therapeutic Goods Act 1989.
Development of this guidance
This guidance has been developed in collaboration with the radiopharmaceuticals technical working group. Technical Working Groups (TWG) have been established by the TGA to bring together manufacturing technical expertise from industry and the regulator to address the application of the currently adopted version of the PIC/S guide to GMP.
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.
- TGA interpretation and expectations for demonstrating compliance PE009-13, the PIC/S guide to GMP for medicinal products
- Implementation of updates to ISO 14644 Parts 1 & 2 (2015)
- Compounded medicines and good manufacturing practice (GMP)
- ARGPM Guidance 20: Radiopharmaceuticals
- ICH guideline Q10 on pharmaceutical quality system
- EMEA/CHMP/QWP/306970/2007 - Guideline on radiopharmaceuticals
- ISO 13408-2:2018 Aseptic Processing of Healthcare Products - Part 2: Sterilising filtration
- Uniform recall procedure for therapeutic goods (URPTG)
Sections of PE009-13 that apply
In general, follow the principles of Part I (for the manufacture of the dosage form) and Part II (for the manufacture of the radiochemical API) of PE009-13, and in addition, all annexes relevant to your operation, such as:
- Annex 1 (manufacture of sterile medicinal products)
- Annex 3 (manufacture of radiopharmaceuticals)
- Annex 8 (sampling)
- Annex 13 (manufacture of investigational medicinal products)
- Annex 11 (computerised systems)
- Annex 15 (qualification and validation)
- Annex 19 (reference and retention samples)