Validation activities are a cornerstone of quality and patient safety in HCT and cell therapy programs. However, their implementation may vary considerably across centres in terms of scope, depth, and application of risk-based principles.
With the increasing complexity of advanced therapies, together with the requirements introduced by the JACIE 9th Edition Standards and EU GMP Annex 15, there is growing value in understanding how validation principles are interpreted and translated into practice at centre level.
To explore this area, a survey has been developed within the EBMT/JACIE. The survey aims to:
- map current validation practices,
- identify areas of convergence, variability and potential gaps,
- highlight pragmatic and risk-based approaches already in use
- support benchmarking and shared learning across the EBMT/JACIE community.
The survey is anonymous, takes approximately 5 to 10 minutes to complete, and results will be analysed and presented only in aggregated form.
Importantly, this initiative is not intended as an audit or compliance assessment. Rather, it is designed to provide a practical overview of how validation is currently approached across centres and to help inform future guidance, educational activities and potential harmonisation initiatives.
Through this survey, the project ultimately seeks to support a proportionate, risk-based and sustainable implementation of validation requirements across both clinical and laboratory settings.
Quality Managers, please take the survey. Your participation and feedback will be invaluable to the success of this important initiative.