Process performance qualification (PPQ)
Also called: PPQ
The batches run to show that a commercial manufacturing process consistently produces product of the required quality.
PPQ is part of stage 2, process qualification, in FDA’s 2011 process validation guidance, after process design and before continued process verification. The batches are run at commercial scale under an approved protocol.
Everything they depend on, from equipment to materials to documents, has to be ready on time.
Where it goes wrong
A late document or material from one partner holds up a slot booked months ahead.
What Spurby does
Tracks every deliverable against the batch date, shows which one will make it slip, and chases its owner.
Spurby for pharmaOn our roadmap