Question 7 of 20 Fundamentals Concept
How does equipment qualification differ from process performance qualification?
Short answer
Equipment qualification shows each piece of equipment or utility is installed correctly and works across its required range, usually through IQ, OQ and PQ. Process performance qualification then runs the real commercial process on that qualified equipment, with trained staff and real materials, to show it consistently makes quality product.
Why
The FDA's 2011 process validation guidance splits Stage 2 into two elements. The first is facility design and qualification of utilities and equipment: confirming they are built and installed to design, and that they operate as the process requires across all anticipated ranges, including under load, interventions, stoppages and start-ups. EU Annex 15 describes the usual sequence.
A user requirements specification states what is needed, design qualification checks the design meets it, factory and site acceptance tests check the delivered equipment, installation qualification confirms correct installation, operational qualification tests operating limits and worst cases, and performance qualification shows the equipment performs under routine conditions. The second element is process performance qualification, or PPQ. It combines the qualified facility, utilities and equipment with trained personnel, the commercial process, controls and components to make commercial batches.
Qualification answers "does this mixer do what we specified?" PPQ answers "does this process, on this mixer, make good tablets every time?" A mixer can pass OQ at every speed and still produce non-uniform blends with a cohesive powder. Both must be finished, in order, before commercial distribution. Equipment PQ and PPQ are sometimes combined for simple systems, but the purpose of each must still be met and documented.
A strong answer covers
- Two elements of Stage 2 in FDA guidance
- URS, DQ, IQ, OQ, PQ sequence for equipment
- PPQ uses real process, materials and people
- Qualified equipment is a precondition for PPQ
- Different questions answered by each
Common mistakes
- Using equipment PQ and process PPQ as interchangeable terms.
- Starting PPQ before equipment qualification is complete and approved.
- Assuming qualified equipment guarantees a validated process.
The interviewer might ask next
When would you justify combining equipment PQ with PPQ, and what risks does that create?