Can somone help me with these items:
Is/are there any major differences in the content required for a project related master plan vs. a site validation master plan?
Also, does a project valdation master plan need to have validation timelines stated within the content?
Hi,
Quite simply an SVMP will provide a high level overview of the validation activities of a site defining the structure and governance of the validation process, whilst a project VMP details the specifics of how you will validate individual processes/systems/equipment/rooms/cleaning.
Content will inherently be different. An SVMP does not prescribe any testing (it is more a mission statement if anything).
Project VMPs do not require timelines although it is not uncommon to see project gant charts attached as appendices. Personally I avoid writing them in unless there is a specific reason directly impacting the validation effort.
Monkey
[quote=Validation Monkey]Hi,
Quite simply an SVMP will provide a high level overview of the validation activities of a site defining the structure and governance of the validation process, whilst a project VMP details the specifics of how you will validate individual processes/systems/equipment/rooms/cleaning.
Content will inherently be different. An SVMP does not prescribe any testing (it is more a mission statement if anything).
Project VMPs do not require timelines although it is not uncommon to see project gant charts attached as appendices. Personally I avoid writing them in unless there is a specific reason directly impacting the validation effort.
Monkey[/quote]
Well, great work! You have helped me to improve my knowledge about this field. Thank you so much for sharing.
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