SMB Validation

What is a PQ?

The Performance Qualification is used to validate a complete integrated process (e.g. a packaging line consisting of several pieces of equipment). Performance Qualification Protocols test the performance and critical parameter testing for each individual piece of equipment on an integrated process. Several test runs are executed for a fixed amount of time on the integrated process. All setup information is documented and samples are collected at the end of the integrated process based on ANSI/ASQC Z1.4-1993 general inspection levels and acceptance quality levels established by the end user. All product criteria and attributes are verified to ensure proper operation of the integrated process to produce the required end product.

As an example a packaging line Performance Qualification is the process that evaluates and documents line performance upon start-up. If a range of container sizes/types are to be run on a line, then the Line PQ will demonstrate line performance for representative container sizes/types. Line PQ is performed after completion of Installation Qualification (IQ) and Operation Qualification (OQ) protocols for the individual units that make up the line. During Line PQ, data are collected concerning critical parameters which could affect package attributes. Equipment is operated at target settings. Line PQ ensures the ability to package the representative container sizes/types in compliance with all procedures and quality standards before saleable product is packaged on the line.