Let’s unpack the relationship between OQ (Operational Qualification) and SAT (Site Acceptance Testing), particularly in the context of production equipment purchase and acceptance procedures, especially common in regulated industries like pharmaceuticals, biotech, food, etc.
🔹 OQ (Operational Qualification)
OQ is a documented process of verifying that the equipment operates according to the manufacturer’s or user’s specified parameters and tolerances under actual or simulated operating conditions.
Purpose in Equipment Purchase
- It’s part of commissioning and qualification (C&Q) and typically falls under GMP validation processes.
- It is usually performed after installation (after IQ – Installation Qualification) to verify operational performance.
- OQ is not typically a part of the procurement contract itself but rather of the validation protocol required before the equipment goes live in a GMP environment.
- Done on-site, after SAT and IQ.
🔹 SAT (Site Acceptance Test)
SAT is a series of functional tests conducted at the customer site, post-delivery and installation, to ensure the equipment meets the agreed purchase specifications and contract requirements.
Purpose in Equipment Purchase
- It is part of the purchase acceptance process.
- Usually jointly executed by the supplier and purchaser immediately after installation.
- It often includes basic functional testing, safety checks, and sometimes dry runs.
- It could be a contractual milestone — like a payment trigger.
- It is not necessarily GMP-validated but more about business/technical acceptance.
🔄 Comparison & Relationship
| Aspect | SAT | OQ |
|---|---|---|
| Purpose | Confirm equipment meets purchase specs | Verify it operates within defined parameters |
| Timing | After delivery and installation | After IQ, before PQ (Performance Qualification) |
| Location | Customer site | Customer site |
| Ownership | Supplier + Customer | Customer (often Quality/Validation team) |
| Scope | Functional tests, basic operation, safety | In-depth testing of operating ranges, alarms, etc. |
| GMP Relevance | Not necessarily (unless tailored for it) | Yes — part of GMP qualification |
✅ Overview
No, OQ is generally not part of the production equipment purchase procedure acceptance. That role is filled by SAT, which verifies that the equipment delivered and installed aligns with the purchase agreement.
However, OQ is a critical step in validating that the equipment is fit for use in a regulated production environment, and it usually follows SAT and IQ. So, while SAT is for contractual acceptance, OQ is for operational/GMP readiness.
