Guideline/Text | Origin/ Organisation | Topic | References |
---|---|---|---|
General GMP guidelines | |||
PE 009-17 Guide to Good Manufacturing Practice for Medicinal Products Part I and Annexes (including Annex 3 on “Manufacturing of radiopharmaceuticals”) | PIC/S | General GMP guidelines | |
WHO Good Manufacturing Practices | WHO | General GMP guidelines | |
Current Good Manufacturing Practice (cGMP) Regulations | FDA | Official US GMP guidelines | U.S. Food & Drug Administraion (2023) |
Volume 4 of "The rules governing medicinal products in the European Union": Good Manufacturing Practice (GMP) guidelines (including Annex 3 on “Manufacturing of radiopharmaceuticals”) | EU | Official EU GMP guidelines | European Commission (2017) |
Specific GMP guidelines for radiopharmaceuticals | |||
International Atomic Energy Agency and World Health Organization: guideline on good manufacturing practices for radiopharmaceutical products | IAEA/WHO | General GMP guidelines on RP preparation | World Health Organization (2020) |
PET Drugs – Current Good Manufacturing Practice | FDA | GMP specific for PET RP manufacturers | FDA (2018) |
PE010-4. Good practices for the preparation of medicinal products in healthcare establishments | PIC/S | GMP recommendations for pharmaceuticals (including RPs) prepared in hospitals | PIC/S (2014) |
Guidelines on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals | EANM | cGRPP for the small scale preparation of RPs | Gillings et al. (2021) |
IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products | IAEA/WHO | GMP for investigational RPs | World Health Organization (2022) |
IAEA/WHO guideline on good manufacturing practices for in-house cold kits for radiopharmaceutical preparations | IAEA/WHO | GMP for in-house prepared cold kits for RP preparations | In progress |
Other documents | |||
EANM guidelines for the preparation of an investigational medicinal product dossier (IMPD) | EANM | Guideline for the preparation of an IMPD, including practical examples | Todde et al. (2014) |
Guidelines on Radiopharmaceuticals | EMA | EU guidelines for MA applicant | EMA. European Medicines Agency (2018) |
Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients | Council of Europe | Requirements for the preparation of medicinal products in pharmacies | Scheepers et al. (2017) |