Standard Operating Procedure for Validation Master Plan Preparation and Approval
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the preparation, review, approval, and maintenance of the Validation Master Plan (VMP) within the pharmaceutical manufacturing facility to ensure systematic planning and execution of validation activities.
2) Scope
This SOP applies to all validation activities conducted within the pharmaceutical manufacturing facility, including process validation, equipment qualification, and cleaning validation. It covers procedures for VMP development, revision, and periodic review.
3) Responsibilities
– Quality Assurance (QA) Department: Leads the development and approval of the VMP and ensures compliance with regulatory requirements.
– Validation Department: Executes validation protocols in accordance with the approved VMP.
– Engineering Department: Provides support for equipment qualification and validation activities.
4) Procedure
4.1 VMP Development – QA: Quality Assurance – Validation Master Plan (VMP) – FDA Guidance for Industry: Process Validation: General Principles and Practices Version 1.0
4.1.1 Define the scope and objectives of the VMP based on regulatory requirements and company policies.
4.1.2 Identify validation activities, including process validation, equipment qualification, and cleaning validation.
4.2 Contents of VMP
4.2.1 Include sections in the VMP such as validation policies, organizational responsibilities, validation approaches, and acceptance criteria.
4.2.2 Outline the sequence of validation activities and their interrelationships to ensure comprehensive coverage.
4.3 VMP Review and Approval
4.3.2 Obtain approvals from designated management personnel before finalizing the VMP document.
4.4 VMP Implementation
4.4.1 Distribute approved VMP to relevant personnel and departments involved in validation activities.
4.4.2 Ensure understanding of VMP requirements through training and communication sessions.
4.5 VMP Maintenance
4.5.1 Periodically review and update the VMP to reflect changes in processes, equipment, or regulatory requirements.
4.5.2 Document revisions and maintain a revision history log for the VMP.
4.6 VMP Retention and Accessibility
4.6.1 Archive superseded versions of the VMP in a controlled manner to maintain document integrity.
4.6.2 Ensure that current and archived versions of the VMP are accessible for regulatory inspections and audits.
4.7 VMP Execution and Documentation
4.7.1 Execute validation protocols and reports in accordance with the approved VMP.
4.7.2 Document validation activities, including deviations, investigations, and corrective actions taken.
4.8 VMP Review and Reporting
4.8.1 Conduct periodic reviews of validation activities against the VMP objectives and acceptance criteria.
4.8.2 Prepare summary reports on validation status, including compliance with VMP requirements.
5) Abbreviations, if any
– SOP: Standard Operating Procedure
– VMP: Validation Master Plan6) Documents, if any
– Validation Protocols and Reports
– VMP Revision History Log7) Reference, if any
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients8) SOP Version
