Connecting the Dots: PIC/S, ICH and FDA regulations in Environmental Monitoring
I received a good question from C. by email. He asked: Is there any description of continuous monitoring systems for Quality Control labs and warehouses in FDA regulations? Can you refer me to some documents?
We encounter this a lot and it's worth a blog to provide a list of documents for referral. And while we can list the regulations, (I will list several at the end) it's often more useful to look at best practices in non-regulatory documents. I refer to industry accepted best practices because regulations usually don't tell us how to perform our operations; they tell us simply what is required. Here we turn to organizations other than regulatory bodies that provide guidance and recommendations on "how" to comply. Two of these organizations are the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, or PIC/S, and The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH.
So, let's look at some documents published by these organizations that attempt to describe practices that support continuous monitoring as a method for regulatory compliance.