ViP Definition
"Validation Master Plans (VMPs)/Validation Plans (VPs) are detailed strategies defining the scope of a validation exercise, and describing the roles and responsibilities of those involved and the control mechanisms to be adopted to ensure its satisfactory outcome."
Companies should not get hung up on the fact that Annex 15 to the EU Guide to Good Manufacturing Practice is prescriptive in its content for a VMP, stating that it "should contain data on at least the following:
- Validation policy
- The organisational structure of all validation activities
- Summary of facilities, systems, equipment and processes to be validated
- Documentation format: the format to be used for protocols and reports;
- Planning and scheduling
- Change control
- Reference to existing documents"
Such an all-encompassing document would never be accurate enough to approve. With so much information in one place, at least one part of it, at any given time, would be undergoing revision. |
