The purpose of a Validation Master Plan (VMP) is to document the measures and
practices employed in the validation of facilities, utilities, process and support
equipment, and major manufacturing processes. A VMP defines your overall
validation philosophy and describes validation efforts, including clean rooms,
processes and support equipment, and critical utility systems. Also, this document
describes how you organize and monitor validation projects.
Since this is a “living document”, to provide guidance and direction to those
participating in the validation project, it needs be updated periodically to reflect any
changes or additions to the original Plan. Specific validation protocol acceptance
criteria may be described and outlined in individual validation protocols rather than
including them in the Plan.
MFDA can assist you in developing VMP’s for any size project and will tailor them to
your specific needs and requirements.
A typical VMP may include, among others, the following sections:
1. Introduction
1.1 Overview
1.2 Purpose
1.3 Plan
2 Definitions
3 Reference Documents
4 Project Description
4.1 Building Overview
4.2 Facility Description
4.3 Facility Flows
4.3.1 Personnel
4.3.2 Product
4.3.3 Raw Material
4.3.4 Soiled Glassware/Equipment
4.3.5 Clean Glassware/Equipment
4.3.6 Waste
4.4 Utility Systems
4.5 Project Organization
4.5.1 Validation Organization
4.5.1.1 Validation Team
4.5.1.2 Quality Assurance
4.5.1.3 Quality Control
4.5.1.4 Facility/Engineering
4.5.2 Protocol Development Approval
4.5.3 Protocol Execution
4.5.4 Consultants/Service Contractors
4.6 Pre-Validation Activities
4.7 Validation Program
4.8 Aseptic & Open Process Validation
4.9 Cleaning Validation
4.10 Method Validation
4.11 Use of Test Equipment
4.12 Revisions to VMP & Attachments
4.13 Training
4.14 Calibration
4.15 Preventive Maintenance
4.16 Change Control
4.17 Re-Validation
4.18 Attachments
