Abstract
BackgroundValidation 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.ResultsThe 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.ConclusionsA 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.
Highlights
Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy
Good radiopharmacy practice Good radiopharmacy practice is described in the “Guidelines on Current Good Radiopharmacy Practice” issued by the Radiopharmacy Committee of the European Association of Nuclear Medicine (EANM)
Todde et al EJNMMI Radiopharmacy and Chemistry (2017) 2:8 therapeutic applications), including extemporaneous preparations based on generators and kits, and simple kit preparation based on Summary of product characteristics (SPC)
Summary
Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. Principles described in the above documents are generally applicable to any process, equipment, system or facility, their practical implementation in the preparation and quality controls of radiopharmaceuticals may require adaptations that meet the peculiar nature of the RPs themselves and of the equipment used for their preparation. Another important issue related to the validation concept is the validation of analytical methods, whose general principles are outlined in ICH Q(2) R1 – Note for Guidance on validation of analytical procedures: text and methodology (ICH guideline), which define the type of analytical methods to be validated and set parameters of concern and acceptance criteria to be considered. General description of the principles of validation of analytical methods will be given in this text; due to the complexity and variety of the involved procedures, instrumentation, etc., they will be the subject of a separate, dedicated guidance document
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