Process Validation is Complicated

Process Validation is complicated. I often say that Process Validation is one of the most complicated topics I advise companies about. It is complicated due to the numerous terminologies used, the many prerequisites, and the complicated nature of biologics processes.
Process knowledge is a key concept and prerequisite for Process Validation. It is really not possible to validate a process without it. For example, we would like to have good information about Critical Process Parameters as a part of process knowledge prior to starting process validation runs. For example, some information about process capability and normal process variation is important to have prior to starting process validation. In a like manner, having control charts for a process can also be helpful.
Although process validation is very complicated, it can be done successfully. A good place to start is by reading the FDA Guidance on Process Validation. Having a good Process Validation Master Plan or a good Process Validation Protocol based on best practices is also very helpful. Having an outside consultant review these along with the PV data and report can also be helpful.