Validation and quality engineers installing equipment

What equipment are you qualifying?

Free checklist for an IQ, OQ and PQ protocol, built on what FDA's process validation guidance says an equipment qualification plan should cover.

Free to read
No sign-up until the draft
Hands off to the right door

ePlan fills in

Rules that apply (drug or device)
Device class
Qualification steps

How it works

IQ/OQ/PQ protocol outline, from one answer

Name the equipment, what it makes and the ranges it must hold.
ePlan lays out the qualification checks FDA's guidance describes, with blanks for your criteria. Your team runs the tests and your quality unit approves.
Read the outline free. Storing oil at the plant? Start an SPCC plan draft.

What you get

IQ/OQ/PQ protocol outline and 1 more document

The check is free. The paperwork after it is drafted at the SPCC Plan Template, Filled In for Your Site door.

The first draft

IQ/OQ/PQ protocol outline (free)

Scope and equipment description
Requirements and acceptance criteria
Installation checks (IQ): built and connected as designed
Operational checks (OQ): across operating ranges
Performance checks (PQ): under production-like load
Deviations, approvals and change control

Modeled on: FDA Guidance for Industry, Process Validation: General Principles and Practices (2011)

Next · 2

SPCC plan for the plant's oil storage

Oil containers and capacities
Containment and drainage
Inspections
Spill response

From public data

What ePlan fills in, and from where

Device class and product codeFDA Product Classification database
Drug CGMP ruleseCFR, 21 CFR part 211
Device quality system ruleseCFR, 21 CFR part 820

5 items

an equipment qualification plan should identify: the tests, the acceptance criteria, the timing, who is responsible, and how results are documented and approved
Source: FDA, Process Validation: General Principles and Practices (2011)

Ready for the paperwork?

Draft a self-certified SPCC plan for a yard, farm or shop with 10,000 gallons of oil or less. Tanks, drainage and spill steps filled in. Free to read.

SPCC Plan Template, Filled In for Your Site →

Questions

IQ/OQ/PQ protocol outline: what people ask

Does FDA expect equipment qualification?

Yes. FDA's process validation guidance says qualifying utilities and equipment comes before commercial-scale manufacturing: verify they are built and installed to the design, then that they operate across all anticipated ranges under a load like routine production. Results go in a report with conclusions.

Source: fda.gov

Who approves the protocol and report?

For drug manufacturing, FDA's guidance says the quality control unit must review and approve the qualification plan and report, citing 21 CFR 211.22. ePlan drafts the protocol; your quality unit decides whether it is acceptable.

Source: fda.gov

What changed for medical device makers in 2026?

FDA's Quality Management System Regulation took effect February 2, 2026. It amends 21 CFR Part 820 and incorporates by reference ISO 13485:2016, the international standard for medical device quality management systems.

Source: fda.gov