Validation Master Plans

Validation Master Plans discuss validation activities across an entire site or within an organization. The Validation Master Plan is a summary of validation strategy. The purpose of the Validation Master Plan is to document the compliance requirements for the site and to ensure that sufficient resources are available for validation projects.

Sometimes Validation Master Plans are written to cover specific departmental validation activities or the validation process for a specific type of system (for example, all programmable logic controllers (PLCs) within a manufacturing process). These master plans describe the specific validation process for that group or system type. Master plans are written to assist an organization with validation strategy or to provide control over a specific process.

The Validation Master Plan is different from a validation procedure (SOP), which describes the specific process for performing validation activities. When plans are written specifically for a single validation project, they are referred to as Validation Plans. Sometimes master plans are named for their function area, such as a Site Validation Master Plan, Pharmaceutical Validation Master Plan, or Software Master Plan.

Validation Master Plan Examples

The Validation Master Plan includes:

Validation Master Plans can also include:

Validation Master Plans should be approved by the head of Site Quality, plus other senior department heads as appropriate. Senior management approval is necessary for Validation Master Plans because their support is essential for the success of the plan.

For information about overseeing your validation group, see our validation project management.

Alternative Document Names and Acronyms

The following terms or abbreviations are sometimes used: Validation Master Plans, VMP.

Validation Document Resources