OBJECTIVE:

• The purpose of this SOP is to define the procedure for the preparation, review, approval, issuance, and control of the Validation Master Plan (VMP) in compliance with WHO TRS / EU-GMP Annex 15 and other applicable regulatory guidelines.
•  The VMP serves as a high-level document summarizing the site’s validation policy, strategy, responsibilities, scope, and validation lifecycle for all systems, equipment, facilities, and processes.

SCOPE:

• This SOP applies to all validation activities carried out at the manufacturing site, including the qualification and validation of facilities, utilities, equipment, analytical instruments, computer systems, cleaning, and manufacturing processes.
• It also covers Preventive Maintenance Scheduling, Calibrations, HVAC validation Product Quality review (PQR), Requalification and Revalidation requirements.

RESPONSIBILITIES:

Designee Quality Assurance (QA):

• Responsible for the preparation, review, issue, and revision of the VMP.
• Ensures that validation activities are planned, executed, and documented Maintains the VMP under document control.

Engineering:

• Provides data and plans related to facility, utility, and equipment qualification.

Quality Control (QC):

• Shall provide analytical method and instrument qualification details.

Production:

• To review the VMP.
• To plan the activities according to the VMP schedule.

Information Technology (IT):

• Supports computer system validation activities.

Head QA:

• Approves the final version of the VMP.

DEFINATIONS:

• Validation Master Plan (VMP): A summary document describing the site’s overall validation approach, scope, organization, schedule, and interrelationship of validation activities.
•  Qualification: The action of proving and documenting that facilities, systems, and equipment are properly installed, operate correctly, and lead to expected results.
•  Validation: Documented evidence that a process, procedure, or system consistently produces a product meeting predetermined specifications and quality attributes.
•  Requalification / Revalidation: Activities performed to maintain the validated state throughout the lifecycle.
• Preventive Maintenance (PM): A planned, systematic activity carried out at predetermined intervals to inspect, service, and maintain equipment, instruments, and utilities in order to prevent unexpected breakdowns, reduce downtime, and ensure reliable performance within specified operating parameters.

PROCEDURE:

Structure and Content of the VMP:

• The VMP shall be prepared by QA following the structure recommended by EU-GMP Annex 15 and shall include, but not be limited to, the following sections:
• Introduction and Objective – Purpose and philosophy of the validation program.
• Scope of Validation – Systems, facilities, equipment, utilities, analytical methods, cleaning, process, and computerized systems covered under the validation policy.
• Validation Policy and Strategy – Overall approach, risk-based strategy, and validation lifecycle.
• Validation Responsibilities – Department-wise roles and reporting structure.
• Facility and Utility Qualification – Including HVAC, purified water, WFI, compressed air, nitrogen, steam, and power systems.
• Equipment Qualification – User Requirement Specification (URS), DQ, IQ, OQ, PQ sequence.
• Process Validation – Protocol and acceptance criteria for product validation, concurrent validation, and continued process verification.
• Analytical Method Validation – Reference to analytical validation plan.
• Cleaning Validation – Approach, matrix, acceptance limits, and revalidation frequency.
• Computer System Validation (CSV) – System inventory, risk assessment, and validation lifecycle.
• Requalification, Calibration and Revalidation Program – Frequency, triggers, and review mechanism.
• Product Quality Review: Planner for the year.
• Preventive Maintenance: Planner for the year
•  Change Control and Deviation Management – Handling of deviations and changes during validation.
• Validation Documentation System – Numbering, archiving, and control of protocols/reports.
• Validation Schedule / Planner – Annual or project-wise validation plan.
• List of Applicable References – Regulatory guidelines, internal SOPs, templates.

Preparation of VMP:

• Designee QA shall initiate the VMP during the project design or commissioning stage and update it as systems and products are introduced.
•  Inputs shall be taken from Production, QC, Engineering, and IT.
•  All validation activities described in the VMP shall follow approved protocols and reports, as per respective qualification and validation SOPs.

Review and Approval:

• The draft VMP shall be circulated by Designee QA to all concerned departments for review.
•  After incorporation of comments, the final version shall be approved by Head QA and Plant Head.
• The approved version shall be assigned a revision number and effective date.

Distribution and Control:

• Controlled copies of the approved VMP shall be distributed to QA, Engineering, and relevant departments as per the Document Distribution Log.
•  The copy submitted to regulatory authorities shall be uncontrolled, marked as: Uncontrolled Copy – For Regulatory Submission Only. Controlled version available with QA.
• All copies shall be logged in the Document Distribution Log maintained by QA.

 Revision Frequency:

• The VMP shall be reviewed at every year or immediately after any significant change such as facility expansion, new system installation, or product introduction.
• Revised versions shall undergo full review and approval as per this SOP.

 Archival:

• QA shall retain obsolete versions stamped “OBSOLETE” for a minimum period of five years.
• The current approved version shall remain active and accessible in QA records or electronic document management system.

REFERENCE:

• EU Guidelines to Good Manufacturing Practice – Part III
• WHO TRS 961, Annex 14

RECORDS:

 REVISION HISTORY: