Using the ISPE’s GAMP Methodology to Validate Environmental Monitoring System Software
Continuous Monitoring Systems (CMS) are used in the pharmaceutical industry to detect out-of-speci cation (OOS) conditions in manufacturing, processing and distribution environments. These modern, Web-based monitoring applications can also send email alarms to notify personnel to take corrective action before OOS conditions, such as extreme temperature or humidity, can have a negative effect on product quality and safety. Because a monitoring system can be considered an “automated system” we can manage this system using the Good Automated Manufacturing Practice (GAMP) guidelines published by the International Society for Pharmaceutical Engineering (ISPE). Speci cally, let’s consider the ISPE’s publications: “The GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture” and “GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems.”
Maintaining environmental conditions within product speci cations is a critical part of GxP operations. Commonly, this involves an automated system providing continuous monitoring and real-time alarming. The conditions that drug products are exposed to must be accurately recorded to prove that the product was created, processed and stored within the correct parameters.
A CMS, like all software-based systems, has a life cycle. It starts at acquisition and installation, proceeds through release and maintenance,
to the system’s eventual retirement. These roughly describe the Software Development Life Cycle (SDLC) which is the typical way to manage a GMP software. In this article, we will focus on the quali cation and validation phases of the Life Cycle of a monitoring software. These phases are important because a CMS software can easily be forgotten; it generally runs in the background of a facility’s daily operations. However, monitoring system software should not be overlooked when it comes to validation.
An inadequately quali ed CMS can result in unwanted observations at inspection time, and uncomfortable questions during customer audits. To ensure a fully GMP compliant software quali cation, we recommend using the GAMP methodology as a reasonable and systematic guide to ensure your monitoring system software performs as expected throughout its life cycle.
Here we outline a ten-step guideline for applying the GAMP methodology
to the validation of continuous monitoring system software. The goal of
this article is to simplify the GAMP approach and highlight the particular steps that you can take to easily integrate your validation efforts into your existing quality management systems. We also strive to show how the effort level required in validation processes is heavily weighted upon monitoring system complexity (i.e. according to the GAMP System Categories). Overall, a GAMP approach to validation as outlined in this article should increase the lifespan, usability, and compliance of your CMS software.