There are several components of the validation Master Plan, and it is imperative that the Master Plan be written before executing the validation process. 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 performingvalidation activities. Cleanrooms and associated controlled environments provide for the control of contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities.