Organoleptic testing on medicinal product formulations

This guidance supplements member companies’ internal processes for evaluating suitability for organoleptic testing in healthy volunteers and should not be used exclusively as standalone guidance. All activities must be undertaken in line with company processes.

The guidance covers:

• Developing testing proposals
• Applying the principles of Good Clinical Practice
• Research ethics committee approval
• Test products
• Test participants including children
• Different forms of testing
• Medical and pharmacovigilance considerations
• Record keeping