Build a Proficient Operational Qualification.

Operational Qualification



The operational qualification is a series of tests to demonstrates if the process or equipment with its subsystems operates correctly within their specified limits consistently and dependably.

Typically, the OQ considers the operation parameters of the system at the full range established by the equipment manufacturer recommendations.

The purpose of the OQ is to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges.

Typically, the OQ is performed to the equipment offline, with no product, or empty of any valued material or data.

During OQ, all items in the test plan are tested and their performance is thoroughly documented. Since this is a prerequisite for acceptance of equipment and the facility.

Operational qualification (OQ) is performed after completed the execution and approval of the installation qualification IQ final report.


Step 1. Prepare a protocol and obtain approval.

Step 2. Execute the execution as established in the protocol.

Step 3. Prepare the final report and obtain approval.

The requirements to properly operate the system are pre-defined in the Design Specification.


The OQ protocol may include, but, is not limited to the following sections, (as applicable)

  • Purpose
  • Scope
  • Background
  • Hardware Description
  • Infrastructure Identification
  • Associated Documents
  • Definitions and Acronyms
  • Hardware Identification, and Operational Verification Instructions
  • Test Steps for Operational Verification, as applicable.
  • Temperature control and variations
  • Servo motors and air flaps
  • Temperature measuring and protection systems
  • Card readers and access systems
  • Pressure and vacuum controllers
  • Temperature distribution
  • Display units and signaling LEDs
  • CO2, oxygen, nitrogen, and compressed air controls
  • Humidity-measuring and control
  • Fan and fan-speed controllers
  • Verification that all loop installations;
  • Insert a brief description of what part of the validated product process.
  • Insert a brief description of the operational function.
  • An integrated loop test verification.
  • Testing of alarms.
  • Testing of interlocks and permissive conditions.
  • Testing of database or data storage integrity.
  • Testing of report generation and event chronicle.
  • Verification of the functionality of the equipment.
  • Challenge of software, where required;
  • Review of system functionality to verify compliance with 21 CFR Part 11.
  • If the system must be 21 CFR Part 11 compliant, verification of audit trails and electronic signature
  • Testing of security levels to prevent;
  • Testing to verify and document ‘Power loss Recovery’.
  • Testing of all interfaces
  • Testing for Electromagnetic interference and compatibility.
  • Analysis of Test Results
  • Acceptance Criteria
  • Incident Reports Summary
  • Conclusions and Recommendations
  • Final Resolution and Release
  • Associated Reference Documents
  • Appendices
  • History of Change
  • Document Approval

What makes OQ successful?

Successful OQ must demonstrate that the equipment and its subsystems will do what they are supposed to do as established in the Design Qualification documents, (URS and FRS).

Operational Qualification must be performed before completing the Performance Qualification.

Depending on the size of the system, Operational Qualification can be combined in one protocol, execution, and report with Installation Qualification or Performance Qualification.

Operational Qualification protocols should be approved before protocol execution to comply with the prospective validation approach.

A copy of the unexecuted protocol should be kept in the validation package.

The unexecuted protocol should be approved at least by the protocol author, system owner, and quality assurance representative.

The final report of the executed protocol should be signed at least by the tester and reviewed by the system owner and quality assurance representative.

The unexecuted protocol should be approved at least by the protocol author, system owner, and quality assurance representative.

The final report of the executed protocol should be signed at least by the tester and reviewed by the system owner and quality assurance representative.

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Three (3) options to create an Operational Qualification Protocol

Option 1. You can create a great protocol, using a template.

You can download a free sample of an operational qualification template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create a customized operational qualification.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.



Validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)), which states the following:

“… a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of the act as to the safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.”












Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!