How to Perform Operational Qualification

IQ OQ PQ Protocols are used at different stages with the same common goal – the system being designed should be able to perform the job it’s designed for. Operational Qualification (OQ) is the process of verifying that each system and its subsystems are able to perform as intended, throughout the operating range which is anticipated.

It is somewhat related to the other protocols (DQ IQ OQ PQ), and is often mistakenly clubbed with them, but they are all in fact very different.

Why is Operational Qualification Needed?

First off, operational qualification is not usually ‘required’, but suggested as part of Good Manufacturing Practice (GMP) compliance. Even the FDA guidelines don’t have a strict requirement for OQ, especially when it comes to frequency. However, it should be given its due importance, like calibration and validation, especially since it’s generally quite straightforward.

Operational Qualification is performed to assess if performance is consistent, within the parameters of the user requirement specification. Some companies combine OQ, PQ and equipment validation after installation into a single activity, often termed OPQ.

How Often Operational Qualification is Done

Before creating an OQ procedure schedule, you should consider the intended use of the equipment. If it is going to be used for different applications and will cater to high performance demands, the tests may need to be quite extensive and frequent.

Conversely, if it’s used rarely or for just one application, the acceptance criteria of performance parameters can be limited. Before-and-after performance should be recorded with detailed documentation to track the adequacy of the regimen.

Typically, an annual OQ frequency is considered appropriate for general equipment and conditions, but the actual schedule can vary based on factors like:

  • The type of instrument
  • Stability of the parameters
  • The specific acceptance criteria for the device or equipment
  • How often the equipment is used

You should aim for a time interval that establishes a high probability of the performance remaining within acceptable limits. Timely OQ and process validation increases dependability on the analytical results gathered, which directly results in higher quality assurance.

How is OQ Performed?

Operational Qualification is quite similar in implementation to design qualification (DQ), except it tests physical equipment. Most equipment is accompanied by an SOP (standard operating procedures) document which outlines the procedures for OQ. Here are some questions you should ask yourself before designing a protocol for OQ:

  • Which standards and procedures should you use?
  • Should you follow manufacturer’s specifications?
  • Will you perform in-house qualification?
  • Does preventive maintenance need to be carried out before OQ?
  • Is OQ required every time the instrument is relocated?
  • For software products, will you need OQ after upgrades?
  • Do you need OQ if the instrument is only going to be used for one application?

OQ is a part of cGMP guidelines, so if you are unsure about how you should proceed, it might be wise to get a professional opinion. Equipment validation services can help you establish a schedule and offer other guidance too.

Scope of OQ

OQ inspections and tests should include tests for at least the following factors:

  • Loop installations
  • Brief description of the validated product process.
  • Loop test verification
  • Alarms
  • Permissive conditions and interlocks
  • Database and data storage integrity
  • Event chronicle and report generation
  • Equipment functionality
  • High-load dry-runs of the software, if required
  • System functionality (for compliance with 21 CFR Part 11)
  • Verification of 21 CFR Part 11 compliance, if needed
  • Security levels (for unauthorized access)
  • Power loss recovery system
  • All interfaces
  • Effects and the ability of equipment to handle electromagnetic interference
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