GMP deviation
Also called: Deviation
A departure from an approved procedure, specification or instruction during manufacturing or testing, which must be documented and investigated.
When something doesn’t go as written, such as a parameter out of range or a step missed, a deviation is recorded and investigated for its cause and its impact on the batch. Companies often set a target of about 30 days to close an investigation, though regulations ask for timely, thorough investigations rather than a fixed number.
Investigations at contract sites often need data from the sponsor.
Where it goes wrong
Questions between the CDMO and the sponsor go back and forth by email while the investigation clock runs.
What Spurby does
Keeps the questions, answers and due dates in one place, and chases the open ones.
Spurby for pharmaOn our roadmap