Guidance on validation and qualification of processes and operations involving radiopharmaceuticals.

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

SUBMITTER: Todde S 

PROVIDER: S-EPMC5824699 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature