Hello,
I would appreciate if someone can help me to get clarification on how we need to categorize the equipment, system and process on the basis what need qualification means IQ and/OQ and/or PQ?
All equipment must go through IQ, OQ and PQ, What do you want to know specifically?
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It is not a regulatory requirement that all equipment should be qualified; but there must be approved procedures to evaluate which equipment is subject to qualification activities. These classification must be based on a risk assessment focusing on how the equipment could impact product quality.
For example; the analysis may conclude that you don’t need to qualify the office water dispensing machine, since it doues not impact product quality. Or that you don’t need to qualify the printer in an office, etc. It depends on the risk evaluation for each equipment.
You can look for guidance documents like ISPE where it shows an example of that risk assessment, made to see what systems need to be qualified or not.
Taken from ISPE:
Q&A: Commissioning and Qualification - Quality Unit and System Risk Assessment
SYSTEM RISK ASSESSMENT
The System Risk Assessment is the application of quality risk management to examine the product quality risk controls for direct impact systems. This assessment identifies the critical design controls (Critical Aspects/Critical Design Elements) and procedural controls that are required to mitigate system risks to an acceptable level. It is important for the project team performing the system risk assessment to include technical SMEs that understand the science behind the process and the risks associated with the critical quality attributes.
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