The purpose of this module was to give you a good baseline understanding of validation. The
module fell broadly into two sections:
? The engineering of validation – the processes, activities, and engineering documentation
involved in validation
? The auditing of validation – how validation activities are captured on documentation to
meet regulatory requirements
Your assignment for this module, as you know, is to fill in the protocol template as if you were
validating this clean-in-place system within a pharma plant, using the relevant supporting
documents.
During the last 8 weeks, each topic and workshop of the course looked at a different part of the
system or a specific part of the verification protocol. So although the blank protocol is over 100
pages long, each section should look familiar.
You’ll notice as you complete the protocol that it’s not all completed in the order it appears in the
document. Every now and then you’ll need to go to an appendix to get information or complete a
task before going back to an earlier section to fill something in. This might be a little confusing,
but keep in mind that protocols are actually laid out for auditors who have no previous
knowledge of your system – not for the convenience of those who are filling them out. Auditors
need to be able to quickly understand what activities were carried out, and what the results
were, to agree that the system is fit for purpose.