Guidance on validation and qualification of processes and operations involving radiopharmaceuticals.
- Todde S 1University of Milano-Bicocca, Tecnomed Foundation, 20900 Monza, Italy.
- Peitl PK 2Department of Nuclear Medicine, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia.
- Elsinga P University Medical Center Groningen, University of Groningen, 9700 RB Groningen, The Netherlands.
- Koziorowski J 4Department of Radiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
- Ferrari V 5GE Healthcare, Amersham, UK.
- Ocak EM 6Faculty of Pharmacy, Department of Pharmaceutical Technology, Istanbul University, 34116 Beyazit, Istanbul Turkey.
- Hjelstuen O 7Institute for Energy Technology, Instituttveien 18, PO Box 40, 2027 Kjeller, Norway.
- Patt M Department for Nuclear Medicine, Radiochemistry, Liebigstrasse 18, 04103 Leipzig, Germany.
- Mindt TL 9Ludwig Boltzmann Institute Applied Diagnostics, General Hospital Vienna, Nuklearmedizin, Vienna, Austria.
- Behe M 11Center for Radiopharmaceutical Sciences ETH-PSI-USZ Paul-Scherrer-Institute, 5232 Villigen-PSI, Switzerland.
- 2018-03-06
Published in:
- EJNMMI radiopharmacy and chemistry. - 2017
English
Background
Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. This document is meant as an Appendix of Part B of the EANM "Guidelines on Good Radiopharmacy Practice (GRPP)" issued by the Radiopharmacy Committee of the EANM, covering the qualification and validation aspects related to the small-scale "in house" preparation of radiopharmaceuticals. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals which are not intended for commercial purposes or distribution.
Results
The present guideline covers the validation and qualification activities following the well-known "validation chain", that begins with editing the general Validation Master Plan document, includes all the required documentation (e.g. User Requirement Specification, Qualification protocols, etc.), and leads to the qualification of the equipment used in the preparation and quality control of radiopharmaceuticals, until the final step of Process Validation.
Conclusions
A specific guidance to the qualification and validation activities specifically addressed to small-scale hospital/academia radiopharmacies is here provided. Additional information, including practical examples, are also available.
Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. This document is meant as an Appendix of Part B of the EANM "Guidelines on Good Radiopharmacy Practice (GRPP)" issued by the Radiopharmacy Committee of the EANM, covering the qualification and validation aspects related to the small-scale "in house" preparation of radiopharmaceuticals. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals which are not intended for commercial purposes or distribution.
Results
The present guideline covers the validation and qualification activities following the well-known "validation chain", that begins with editing the general Validation Master Plan document, includes all the required documentation (e.g. User Requirement Specification, Qualification protocols, etc.), and leads to the qualification of the equipment used in the preparation and quality control of radiopharmaceuticals, until the final step of Process Validation.
Conclusions
A specific guidance to the qualification and validation activities specifically addressed to small-scale hospital/academia radiopharmacies is here provided. Additional information, including practical examples, are also available.
- Language
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- English
- Open access status
- gold
- Identifiers
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- DOI 10.1186/s41181-017-0025-9
- PMID 29503849
- Persistent URL
- https://sonar.ch/global/documents/221267
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