This Site Validation Master Plan (SVMP) describes <Company>, <location> facility’s overall approach and intentions for establishing validation activities. It will provide an overview of the <Company>, <location> validation approach and planning to complete validations in accordance with GMP regulations. The Site Validation Master Plan is intended to be prescriptive and dynamic, providing guidance and direction for studies and projects, and maintaining a level of flexibility to allow for changes in processes and requirements. Although a live document, the intent is not to update the Site Validation Master Plan for each project which requires qualification and therefore will not be inclusive of all validations. On an annual basis this document will be fully updated with applicable site and validation information/details/ schedules, then reissued and approved.
This Site Validation Master Plan applies to the facilities, equipment, and processes that are subject to cGMPs and within the responsibility of <Company>. This includes, but is not limited to, an assessment of the following areas: facilities, equipment, processes, software systems and revalidation activities. The validation activities in this plan shall be prospective, unless otherwise determined by the quality group. All Validations shall follow the same general validation approach.