Vendor Manuals Passed Off as Protocols
The manufacturer's FAT/SAT documents were filed as qualification. They prove the vendor's equipment works — not that your process performs on it, in your facility, with your utilities.
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IQ/OQ/PQ that proves the equipment works.
An oven, a retort, a CIP skid, a packaging line — every piece of equipment your process depends on needs the same three proofs: installed as designed, operating across its range, performing consistently under real conditions. We develop and execute IQ/OQ/PQ protocols that test the equipment you actually run, not the brochure version.
WHY NOW
Three proofs, in order.
Each phase answers a different question. Skipping one doesn't save time — it borrows trouble.
IQ — InstallationInstalled correctly: as-designed, as-specified, with correct utilities, materials of construction, and calibrated instruments — documented, not assumed.
OQ — OperationalOperates across its range: worst-case challenges, alarms, interlocks, and failure modes tested — not just the happy path.
PQ — PerformancePerforms consistently: the process, on the equipment, under real operating conditions, with the people who will actually run it.
WHERE IT BREAKS
The four qualification failures we see most.
Qualification packages that look complete — until someone who knows the equipment reads them.
OQ That Never Challenges Anything
Operational qualification ran the equipment at its comfortable setpoints. Alarms, interlocks, and worst-case conditions were never tested — so the first real challenge happens during production.
PQ Run Once, Filed Forever
Performance qualification was a single campaign years ago. Since then: new products, changed parameters, replaced parts — and no requalification to prove the state still holds.
Calibration Disconnected From Qualification
Instruments were calibrated on one schedule and qualified on another, with no link between them. An out-of-tolerance instrument quietly invalidates the qualification it supported.
OUR METHOD
Protocols built for your floor.
We write protocols your team can actually execute, support the execution, and close the discrepancies honestly — so the package survives review.
Protocol Development
IQ/OQ/PQ protocols written against your URS and risk assessment — clear acceptance criteria, defined sampling, and steps sequenced for the floor, not the desk.
Execution Support
On-the-floor support during execution: directing testing, witnessing critical steps, and keeping documentation contemporaneous instead of reconstructed.
Discrepancy Resolution
Deviations investigated to root cause with justified dispositions — retest, repair, or accept with rationale. No pencil-whipping, no buried failures.
Lifecycle & Requalification
Requalification triggers and schedules tied to change control, calibration, and preventive maintenance — so the qualified state doesn't expire silently.
WHERE IT APPLIES
One method, five industries.
Cannabis is our home base — the method was built there first. The same evidence discipline serves each industry below, mapped to its own regulations.
Food & Beverage
Preventive controls, supplier verification, environmental monitoring, and traceability under 21 CFR Part 117 and FSMA.
Dietary Supplements
Component qualification, master manufacturing records, and laboratory controls under 21 CFR Part 111.
Cosmetics
Safety substantiation, GMP records, and adverse-event readiness under MoCRA.
Pet Food
Preventive controls for animal food, supplier programs, and sanitation under 21 CFR Part 507.
QUESTIONS
Equipment qualification, answered.
Can we use the vendor's IQ/OQ as our qualification?
As a starting point, not a substitute. Vendor testing doesn't cover your installation, your utilities, your process, or your operating ranges. We leverage vendor packages to reduce redundant testing — then qualify the rest.
How long does an IQ/OQ/PQ take?
It depends on equipment complexity and readiness, not on a fixed template. A single skid with good documentation moves in weeks; a full line with gaps takes longer. We scope honestly after a short assessment — never by guessing.
Do we need PQ for every product on shared equipment?
Not necessarily. We use worst-case and bracketing approaches — qualify the hardest-to-make product or the bounding conditions, with a documented rationale for what the PQ covers.
What about equipment installed years ago with thin records?
Retrospective qualification: we assess what's known, test what's critical, and build a justified qualified state from evidence — documenting exactly what was proven and what was assessed by history.
Do you execute protocols on-site?
Yes. Execution support is on-site work — directing tests, witnessing critical steps, and managing discrepancies in real time. Document development and review run remotely.
Don't let the first gap be found under pressure.
Start with a free call about your equipment — what's qualified, what's thin, and what an inspector would challenge first. We'll name your top 3 GMP risks and give you an honest fit assessment. No pressure, no pitch.