The following documents are the most common types of validation plan documents:
1. SVMP – Site Validation Master Plan
2. VMP – Validation Master Plan
3. VP – Validation Plan
4. VPP – Validation Project Plan
So what’s the difference between these 4 documents, why are they sometimes (apparently) used interchangeably? I will try to explain this in an Easy to Understand format. The question is whether this should be a top-down or bottom-up approach.
I’m going to start with the VMP, the Validation Master Plan is a document that is usually owned by a department or functional area, for example there might be an Engineering VMP, Utilities VMP or Automation VMP. The purpose of the VMP is identify all areas under validation and to specify the overall validation approach for that department or functional area as well as giving a high-level approach to the validation activities/deliverables that occur underneath the VMP.
Taking a Scaled Approach
In this context, a VMP will reference it’s subordinate Validation Plans – it wouldn’t make logical sense to group an entire departments validation efforts under the umbrella of one plan so it is the norm to reference individual validation scopes within a logical group (such as a department) from the VMP. For example, Automation may fall under either IT or Engineering, or it might be a department in its own right (depending on the extent of the scope of systems and processes that are subject to formal validation).
This means that the IT or Engineering VMP would include a high-level description of the Automation component and then reference the Automation VMP, the Automation VMP would then contain all information pertinent to only automation items, similarly to the way in which the VMP as mentioned above will include departments, the Automation VMP would contain specific systems and processes and their respective subordinate VPs would be referenced.
Each of the systems under the Automation VMP would be listed and described (at a high-level) in the Automation VMP and the VMP would reference the actual Validation Plans for each system that belongs to the Automation department, for example there may be a Building Management System (BMS) VP and a Manufacturing Control System (MCS) VP.
The Nitty Gritty
The actual VP for each system or process would include all of the relevant scope and detail necessary to validate that particular system. The VP would go down to a level of granularity such that the validation methodology would be defined and explained – this would include all aspects from detailed design though testing and reporting; periodic review and retirement of the system.
The VPP is a Validation Project Plan; basically this is identical to the VP but utilised for projects. On completion of a project the on-going validation activities would be referenced in the VMP and controlled by the VP for that particular system or process; the VPP is effectively converted to a VP.
Under the Site Umbrella
The SVMP is a VMP for the entire site or facility, a high-level document that can be used to determine where the validation of a certain system or process lies, this will reference the relevant VMP which will lead to the VP itself that holds the detail.
Due to the extent and scope of Validation and Validation Planning, this hierarchal structure has become the norm in most companies. Whilst it is completely possible and viable to scale these documents to suit business needs, a company with hundreds of validated systems and processes would find that their SVMP is working as a massive document index and furthermore, it would be in revision so frequently as part of multiple lifecycles that a deadlock could occur holding up work whilst waiting to update the SVMP.
By having a structured set of Validation Plans, a facility is able to allow multiple operations and projects to continue concurrently whilst only minimally impacting external groups or departments. At the same time, different methodologies are applicable to different systems and process based on a variety of factors including complexity, risk, safety, ease of implementation, etc.
Summary
In summary, the SVMP, VMP, VP and VPP are all scalable validation planning documents; they are broken down from the site level to the departmental level, they exist on a per system or process basis and projects are driven by their own individual VPP; this is to allow ease of use whilst minimising impact on different departments. At the same time these documents are generated with backward and forward traceability such that being able to find a specific component and an explanation of the validation approach should never be too difficult in a well-documented environment. An auditor should be able to find the validation documentation for a specific system by identifying a given VMP from the SVMP and then the VP or VPP from the VMP.
Further Reading
