VALIDATION & COMPLIANCE
Answers to the questions our clients ask most often about cleanrooms, laboratories, compliance, and our services — straight answers from people who work in controlled environments every day.
Q: What is IQ/OQ/PQ validation?
IQ stands for Installation Qualification — documenting that your equipment or system has been installed correctly. OQ stands for Operational Qualification — documenting that it operates within defined parameters. PQ stands for Performance Qualification — documenting that it consistently performs to specification under real operating conditions. Together they form the documented evidence that your system is fit for its intended purpose.
Q: Do I need to validate my cleanroom?
If your cleanroom is used for pharmaceutical manufacturing, sterile compounding, medical device production, or any other regulated activity, validation is a regulatory requirement — not optional. Your regulator will expect documented IQ/OQ/PQ evidence demonstrating that your cleanroom performs to specification.
Q: How long does cleanroom validation take?
Validation timelines depend on the size and complexity of your facility and the scope of the validation programme. For a straightforward ISO Class 7 or 8 pharmaceutical cleanroom, a full IQ/OQ/PQ programme typically requires 2 to 6 weeks to execute and document, following completion of commissioning.
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