Good Manufacturing Practice (GMP) and Leak Testing Standards

What is Good Manufacturing Practice (GMP)?

This article covers the relationship between Good Manufacturing Practice (GMP) and leak testing standards. GMP is a term commonly used in the food, pharmaceutical and medical device manufacturing community. GMP is a set of guidelines for manufacturers to follow that ensures the products they produce are of high quality and do not put consumers at risk.

The guidelines cover manufacturing, testing and quality assurance. An extension of GMP is Good Automated Manufacturing Practice (GAMP), a set of guidelines which originated in the UK for users of automated systems in the pharmaceutical industry. 

Are Universal Leak Testing Standards Realistic?

The underlying principle is that quality should be built in at every stage of manufacturing from receiving to shipping.

These concepts would form a good foundation for any quality management system regardless of the industry, however, the manufacturing industry as a whole does not have a set of guidelines.  Firms have the option to pursue the ISO 9001 certification, but there is a great deal of latitude with regard to the effectiveness of quality management systems created by individual entities.

In regard to leak testing specifically, because of the millions of different products manufactured around the world that it would be impractical to create standard leak tests for, say, car headlamp lenses, as the lens manufacturers are striving for improvement like anyone else, and testing evolves as they seek better leak tightness and perhaps a competitive advantage. Changes in leak rate specifications could also lead to changes in technique. So given that there are no real standard tests or procedures for universal adoption, even within categories of products, it’s important to understand the different leak test methods and how to create the various tests.

Once the leak test has been created it can be validated with a gage R&R study, challenged with a calibrated leak master, and then monitored in use with SPC or SQC methods so that quality can be built in at every stage, largely in line with the GAMP guidelines.

Uson can help

We can help you with evaluation of your proposed test method or work with you to create a test from scratch. Contact our team of experts at +1-281-671-2000 and let’s talk about your application.