IQ OQ PQ and Its Role in Labeling System Validation

In highly regulated industries including medical device manufacturing, pharmaceuticals, and life sciences, regulatory authorities such as the FDA and the European Union (EU) have guidelines related to process validation to confirm a company’s processes will result in reliable outputs and meet all necessary quality standards.

Process validation involves attention to detail and documentation for every step in the process of manufacturing as proof that those steps have been tested and validated to ensure quality outputs. This includes the process of manufacturing the product or device, as well as processes related to software systems such as barcode label design and printing.

What is IQ OQ PQ for Labeling System Validation?

The purpose of process validation for labeling systems is to establish documented evidence that the software is correctly installed, operates according to requirements, and performs safely. It also demonstrates that the manufacturing process, under normal operating conditions, will consistently produce conforming products and outputs.

 IQ OQ PQ are sequential activities that manufacturers need to carry out to validate their manufacturing processes. In each phase of the validation process, documents are compiled with detailed results of each qualification test.

Regulatory Requirements

The medical device, life sciences, and pharmaceutical industries face many labeling regulations that have been established to help protect patients and providers. Each of the regulations below have processes and steps that must be outlined and included with labeling system validation as part of IQ OQ PQ:

Features and processes within the labeling system must be defined, tested, and have a “pass” status to validate compliance with these requirements.

When to Perform Labeling System IQ OQ PQ Testing and Validation

Manufacturers in regulated industries are typically required to validate their systems every three years. There are also a variety of events that may occur that require validation documentation to be updated and/or inspected. Some examples of “events” that may trigger the need to perform IQ OQ PQ testing and validation include:

Due to the complexity of software, a small local change may have a significant global system impact. When any change is made to the software, the validation status of the software needs to be re-established and a validation analysis should be conducted not just for validation of the individual change, but also to determine the extent and impact of that change on the entire software system. Based on this analysis, you should then conduct an appropriate level of software regression testing to show that unchanged but vulnerable portions of the system have not been adversely affected.

Validation and proof of quality outputs with safe processes is required to pass an audit and avoid the risk of fines or, worst-case, production shutdowns.

Whether you are a new company performing labeling system validation for the first time, or a long-established manufacturing company that is experiencing changes within your labeling system, there are a few options to work through IQ OQ PQ testing documentation and validation.

Labeling is a core component of global regulatory compliance. Working with your internal team and labeling software providers to perform IQ OQ PQ labeling system validation helps to ensure both compliance and safe operation of your products or devices by providers and patients.

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