Understanding Impact: Indirect and Direct systems
This blog post from Vaisala discusses the definition of a direct and indirect system as it relates to environmental monitoring systems.
According to the ISPE, an Indirect Impact System is:
“A system that is not expected to have a direct impact on product quality, but typically will support a Direct Impact System. These systems are designed and commissioned following Good Engineering Practice only.”
It follows therefore that a Direct Impact system is a system that has a direct impact on product quality.
In what I call a “standard pharmaceutical scenario,” we are dealing with a product that is sensitive to temperature, has published storage specifications from stability studies, and the product will be considered adulterated if the manufacturer is unable to prove, through gap-free records, that the product was stored within the published storage specs.
Generally, the GMP System of record that is used to show that the product was stored appropriately is the monitoring system. In this sense a monitoring system has a direct impact on product quality. One could argue that a company’s decision to release or not release a product are dependent directly on records and data collected by this system.