What is PQ and why is essential in clean room
Performance Qualification (PQ) is the final stage of the cleanroom qualification process, where it is verified and documented that the controlled environment is able to maintain the established operating conditions in a constant and repeatable manner.
This is not just a technical procedure: PQ is a necessary condition to ensure compliance with GMP regulations, in particular Annex 11, and to ensure that every production activity carried out in a controlled environment is scientifically valid and documented.
The four stages of the qualification in the clean room
To understand the role of PQ, it is useful to remember the four stages of qualification:
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Design Qualification (DQ) – verification of the correct design according to functional and regulatory requirements.
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Installation Qualification (IQ) – control of installation of the installations and instruments.
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Operational Qualification (OQ) – verification of operational features under controlled conditions.
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Performance Qualification (PQ) – validation of performance under real conditions, in the presence of personnel and production activities.
PQ, therefore, simulates normal operation and serves to demonstrate that everything that has been designed, installed, and tested actually meets the requirements under real operating regime.
Tools and parameters to monitor in Performance Qualification
During the PQ, a series of parameters critical for environmental quality are monitored:
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Particle count in class (e.g. ISO 5, ISO 7 or ISO 8)
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Microbiological charge (active, passive and contact samples)
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Temperature and relative humidity
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Pressure differentials between environments
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Air flow rate and direction (e.g. LAF, RABS)
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Environmental recovery time (after opening doors or still line)
Monitoring must be carried out according to a documented plan, which includes the measurement frequencies, the critical areas to be checked (e.g. zone A, B), and the acceptable limits provided for by the legislation.
Common mistakes in PQ management
Even experienced companies can incur errors that compromise the validity of PQ. Here are the most frequent:
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Underestimating real operating conditions (e.g. not including staff or actual production in the test)
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Using instruments that are not calibrated or non-compliant with 21 CFR Part 11
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Forgetting the parallel documentation (data logs, digital signatures, data integrity)
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Not repeating PQ after significant changes to plants or layout
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Limiting oneself to an initial PQ without planning the periodic re-test
A poorly conducted PQ can lead to serious surveys during inspection and non-compliance of the production process.
Performance Qualification and continuous monitoring: a strategic alliance
More and more GMP companies are choosing to integrate the initial PQ with continuous environmental monitoring systems, which allow them to:
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Track critical parameters in real time
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Automate the data collection
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Quickly detect any deviations
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Simplify document management
Devices such as BioTrak, AeroTrak, and digital pressure sensors are fully compatible with PQ needs, especially if supported by validated software that complies with FDA and EU GMP guidelines.
Operational checklist for an effective PQ
Before the PQ:
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Validate tools and protocols
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Define critical zones and limits of acceptability
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Drain sensors and prepare digital logs
During the PQ:
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Simulate real conditions (shifts, operators, production)
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Collect multiparametric data
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Register all activities (signature, time, place)
After the PQ:
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Draft the final report with data analysis
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Store certificates and digital logs
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Set the recurring PQs
How QSGroup supports you in performance qualification
QSGroup supports its customers in the complete management of Performance Qualification, providing:
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Validated and calibrated instruments (particle, microbiological, pressure, temperature, TOC)
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On-site and cleanroom services, even in the presence of active production
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Assistance in drafting and reviewing PQ protocols
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Reports compliant with ISO 14644, Annex 1, and FDA
Thanks to REDIGO mobile solutions and continuous technical support, we can help you successfully pass each audit.
Download the free PDF checklist
Download the PQ checklist for clean rooms (PDF)
An operational tool to validate performance correctly in the GMP environment.
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