The "Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture" (in short: GAMP) was published in 1995 by the UK Pharmaceutical Industry Computer Validation Forum. This guide has developed into the standard regulatory framework for the validation of computer-supported systems in the pharmaceutical industry (manufacturers and suppliers).
The GAMP regulations are not legally required but are generally recognised in the pharmaceutical industry as the "state of the art". In addition, Good Practice Guides are available regarding specific aspects, for example the guide "Validation of Process Control Systems".
The current version 5 has been available since the end of February 2008. We have successfully implemented this standard in all products producted in 2013 and beyond. Thus guaranteeing our products and software are developed within the best available technology processes.
Note: GAMP 5 is sometimes erroneously regarded as an official guideline. It is a recognised standard as a guide for validation.
In our view, the high quality of a development process also involves an efficient, methodical and process-oriented procedure. With this in mind, Berlinger works in accordance with the established V-model and the specifications of GAMP5. We have successfully integrated this tried-and-tested methodology over the years into product development and manufacture, which is reflected positively in various product approvals (WHO etc.).
Along each shipment of our devices there is a validation certificate attached which provides proof of the testing, accuracy, performance and efficiency of the product. The accuracy of each individual monitor is tested in accordance with NIST standards and in compliance with ISO 17025 requirements. In addition, a detailed validation package is available on request, which further documents the extensive testing.