Hello good people of the world! Today’s post is about dealing with legacy processes and equipment from a validation perspective.
I’ve worked in two plants that have legacy processes/equipment. By legacy, I mean processes/equipment that can be decades old. These processes have been producing products for the market for a long time. Initial validations will not meet the standards of today, if they exist at all. It is typical that documentation for legacy processes/equipment will not meet the today’s standards as well, and may also be nonexistent.
So how do you handle legacy processes/equipment from a validation point-of-view? First it is important to consider that because the product has been on the market for some time, there is a proven track-record. This must be leveraged. Also, legacy processes have been audited internally and externally many times. It is important to look at those audits to see what gaps and/or risks have been identified.
The next challenge is how to document changes to legacy processes/equipment. It can be difficult to track changes to equipment that, for example, does not have up-to-date P&IDs (Piping and Instrumentation Diagrams). Because creating missing documentation after installation can have a large resource cost, it will be up to the organization to determine their documentation needs and what risks they are willing to assume. This can lead to challenging conversations within the organization and unique validation programs.
What have you learned working with legacy processes/equipment? Comment below.