DOI: 10.1186/s41181-017-0025-9Pages: 1-29

Guidance on validation and qualification of processes and operations involving radiopharmaceuticals

1. University of Milano-Bicocca, Tecnomed Foundation

2. University Medical Centre Ljubljana, Department of Nuclear Medicine

3. University Medical Center Groningen, University of Groningen

4. Linköping University, Department of Radiology and Department of Medical and Health Sciences

5. GE Healthcare

6. Istanbul University, Faculty of Pharmacy, Department of Pharmaceutical Technology

7. Institute for Energy Technology

8. Department for Nuclear Medicine, Radiochemistry

9. General Hospital Vienna, Ludwig Boltzmann Institute Applied Diagnostics

10. Department of Biomedical Imaging and Image Guided Therapy, Division of Nuclear Medicine, Medical University of Vienna

11. Center for Radiopharmaceutical Sciences ETH-PSI-USZ Paul-Scherrer-Institute

Correspondence to:
S. Todde
Email: sergio.todde@unimib.it

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Abstract

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.

This article is freely available, click here to access the full text/PDF

  • Accepted: May 23, 2017
  • Online: Jun 29, 2017

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