Operational Qualification (OQ) Protocol and Report Format

In short: Operational qualification (OQ) is the documented check that installed equipment or a system works as designed across its anticipated operating ranges. This page explains what EU GMP Annex 15 expects from OQ and gives an example protocol and report format that you must adapt to your own quality system.

What is operational qualification?

EU GMP Annex 15 (Qualification and Validation, 2015) defines OQ as the documented verification that facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.

Key points from Annex 15, section 3:

OQ normally follows installation qualification (IQ). For simple equipment the two may be combined as an installation/operation qualification, IOQ (3.10).
OQ should include, but is not limited to, tests developed from knowledge of the process, system and equipment to show it operates as designed, and tests of the upper and lower operating limits and/or worst-case conditions (3.11).
A successful OQ should allow the operating and cleaning procedures, operator training and preventive maintenance requirements to be finalised (3.12).

In practice this means: identify the critical operating parameters, challenge them at the limits, verify controls, alarms, interlocks, outputs and instrument calibration, and only then release the item for performance qualification (PQ).

Documentation expectations

Annex 15, section 2, applies to OQ as to every qualification document:

The protocol defines the critical systems, attributes and parameters and the associated acceptance criteria (2.4).
Qualification documents are approved by the personnel defined in the pharmaceutical quality system (2.2).
A significant change to the approved protocol during execution is a deviation and must be scientifically justified (2.7).
A result that fails a predefined acceptance criterion is recorded as a deviation and investigated; its implications are discussed in the report (2.8).
The report summarises results against the acceptance criteria and ends with a recommendation on the outcome (2.9).
Release to the next stage (PQ) is formally authorised (2.10).

Example OQ protocol format

This is an illustrative template. Replace the bracketed items with details from your own approved validation master plan, user requirements and risk assessment. See also Validation Master Plan.

Header and approval

Field	Entry
Protocol number
Title	Operational Qualification of [equipment or system]
Site name and address
Related validation protocol / IQ reference
Page	___ of ___
Written by / date
Approved by / date
QA approval / date

1. Objective

To confirm that the [equipment or system] operates according to its specifications, and to record the information and data that demonstrate it functions as intended across its operating ranges.

2. Scope

OQ is carried out after IQ is complete and approved, and again (fully or partly, as decided through change control) after a modification or relocation that may affect operation.

3. Responsibilities

Role	Responsibility
Operator or user department	Performs the tests and records the data
Supervisor	Supervises the work, checks records are complete, writes the deviation report and the OQ report
Quality Assurance	Reviews and approves the protocol, deviations and report

4. Materials, equipment and documents

List of calibrated test instruments and apparatus, with ID and calibration due date (Chart 1).
Draft or approved operating SOPs and data sheets for normal operation (Chart 2).
Training records showing operators are trained (Chart 2).
Manufacturer’s manuals (Chart 2).

5. Procedure

Record the calibration status of the test apparatus and instruments (Chart 1).
Check documents, training and manuals (Chart 2).
Test and record the operation of control points, interlocks and alarms (Chart 3).
Test and record outputs (Chart 4).
List the calibration requirements of the system and record the calibration status (Chart 5).
Challenge the system at normal and, where appropriate, worst-case or upper and lower operating limits (Chart 6).
Record every deviation, then write a deviation report with justification and impact.
Write the OQ report and send the package to QA for review and approval.

Chart 1: calibration of test apparatus and instruments

Apparatus / instrument	Calibration method	Calibration date	Due date

Performed by / date: ______ Verified by / date: ______

Chart 2: document, training and manual check

SOP title and number	File location	QA approval date

Course / SOP number	Staff name	Training date

Equipment make and model	Manual available
	Yes / No

Performed by / date: ______ Verified by / date: ______

Chart 3: control points and alarms

Control point / alarm	Test method	Acceptance criterion	Result	Date

Chart 4: outputs

Output	Acceptance criterion	Result	Date

Chart 5: calibration of the equipment or system

Calibration SOP (short title and number)	Result	Date

Chart 6: specific challenge tests

Record each test under normal conditions and under worst-case conditions or at the upper and lower operating limits, with the set point, the observed result and the acceptance criterion.

Test	Condition (normal / low limit / high limit)	Acceptance criterion	Result	Pass / Fail

Each chart ends with lines for performed by / date, deviations noted, and verified by / date.

Deviation report

Section	Content
Deviation(s)	Describe each, with its reference number
Justification for acceptance	Scientific reason the result can be accepted, or the corrective action
Impact on operation	Effect on product quality, the validated state and later qualification stages
Written by / date

Example OQ report content

The OQ report should include:

date the study started and date it finished;
observations made and problems encountered;
completeness of the information collected;
a summary of the deviation report;
results of the control and alarm tests, with sample data where appropriate;
location of the original data;
any other relevant information; and
a conclusion on whether the equipment or system operates as intended, with a recommendation on release to PQ.

The report is written by a named person, dated, and approved by Quality Assurance.

Release for use

Do not release equipment for routine use until the qualification stages required by your protocol are complete and calibration, cleaning, maintenance, training and related tests are acceptable. For many items the next step is PQ (PQ protocol and report format).

Record retention

Keep the signed protocol, raw data and report under your document control system. Where qualification data support the release of batches, retain them for at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 section 4.11, or 5 years after QP certification if longer; also 21 CFR 211.180(a)), and longer if local law or the marketing authorisation requires.

Frequently asked questions

Is OQ always separate from IQ?

No. Annex 15 allows a combined IQ/OQ (IOQ) depending on the complexity of the equipment, if the protocol justifies it.

Why test at upper and lower limits?

Because OQ must show the equipment performs throughout its anticipated operating range, not only at the set point. Annex 15 asks for tests of upper and lower operating limits and/or worst-case conditions.

Can OQ be done with product?

Annex 15 places tests using production materials, qualified substitutes or simulated product at worst-case batch sizes in PQ (3.14). OQ tests focus on whether the equipment operates as designed, so many are run without product.

What happens if a test fails?

Record it as a deviation, investigate under your procedures, justify any acceptance or repeat, and discuss the implications in the report (Annex 15, 2.8).

References

European Commission, EudraLex Volume 4, EU GMP Guidelines, Annex 15: Qualification and Validation (2015), sections 2.2, 2.4, 2.7 to 2.10 and 3.10 to 3.14, and the glossary definition of OQ.
European Commission, EudraLex Volume 4, Part I, Chapter 4: Documentation (revision effective 30 June 2011), section 4.11.
US FDA, 21 CFR 211.180(a), General requirements (records retention).