VALIDATION MASTER PLAN (VMP)
APPROVAL OF VMP: Signing of this approval page of Validation master Plan EL/QAD/VMP-001 indicates agreement with the qualification and validation procedure described in this document. If any Modification in the document becomes necessary, an addendum shall be prepared and approved.
Introduction: Company is a well-established professionally managed Public Limited company. It has good presence in Domestic & Export Market of liquid Injection, Respules and Eye drops. The facilities are well equipped with latest plant machineries, instruments & equipment’s.
The company was established in the year ___________________ since then Company has recorded an excellent growth and caters to the requirements of the local & neighboring countries markets.
The Production facility of Company, Formulation Division is designed to produce the following sterile products. The facility is dedicated for Liquid Injection.
- Small Volume Sterile Products
- Large Volume Sterile Products
- Tablet and Capsule Oral dosage form
The entire plant has been designed with intent to comply current GMP requirements / regulations/ guidelines of various global regulatory bodies e.g. World Health Organization (WHO) and Schedule-M requirements of Indian Drugs & Cosmetics Act.
To ensure the manufacturing of pharmaceutical products in company according to international standards, there are several guidelines that are considered for the planning, construction, start-up and validation of the buildings, equipment has and processes.
As per the current design, the premises dedicated Manufacturing and packing area, quality control, Microbiology laboratory, Warehouse, Quality Assurance, Utility area and admin Block.
Utility consist of
- HVAC system
- Purified Water System
- Water For Injection
- Compressed air system
- Nitrogen Air system
- Effluent Treatment Plant
- Boiler and Chilling System
All the classified area used for manufacturing of pharmaceutical drug products are separated from the Unclassified area by Airlock system and entry/ exit procedure to this area are controlled by specific change room as per the cGMP norms. All area, utility and process are in function with a validated condition
Objective: The objective of this Validation Master Plan (VMP) is to provide a complete overview to the validation activities, its organizational structure, content and planning.
This Validation Master Plan describes and summarizes the philosophy, intentions, approach and commitment to perform validation of its facilities, equipment, utilities and processes / systems in accordance with current Good Manufacturing Practices (cGMP) / current Good Laboratory Practices (cGLP) and Good Engineering Practices (GEP).
Scope: Validation Master Plan provides the scope of validation exercise, responsibilities of personnel involved in validation activities, procedure for qualifications/ validations, frequencies/ tentative schedules for various validation tasks and documentation methodology to be followed.
This Validation Master Plan (VMP) is applicable to all the qualification/ validation activities carried out at company. Himachal Pradesh used for production, storage, quality control and distribution of drug products.
This document covers the philosophy and approach on the qualifications/ validations of the below mentioned areas, but not limited to:
Philosophy, intention and approach to validation: The validation philosophy adopted by this organization is based on the principles outlined in WHO Technical Report Series No. 1019, Annex 3. It emphasizes a lifecycle, risk-based, and science-based approach to validation and qualification activities, ensuring consistent product quality, patient safety, and regulatory compliance.
Key Tenets of the Validation Philosophy:
Quality by Design, Not Testing Alone: The validation philosophy embraces the idea that quality must be built in, not merely tested at the end.
Inspection or testing alone cannot guarantee quality; instead, understanding and controlling the process, equipment, systems and method design is essential.
Lifecycle and Risk‑based Approach:
Validation is not a one‑time event but integrated into the entire lifecycle —from design / development, through qualification, routine operation, and eventual retirement/decommissioning.
The scope, extent, and depth of validation (or revalidation) are determined by scientific understanding, prior knowledge, experience, and risk assessment.”
The scope and extent of validation activities are determined using quality risk management (QRM) principles. This ensures that critical systems processes and parameters identified as critical require the appropriate level of scrutiny.
Flexibility & Scientific Justification:
The Validation Master Plan (VMP) establishes, guiding principles that allow adaptation to the specific characteristics of the facility, product, process, and regulatory requirements.
Decisions, such as the number of batches, test points, sampling, and challenges, should be scientifically justified and thoroughly documented.
Documentation, Transparency & Traceability:
All validation steps, decisions, changes, deviations, and conclusions has thoroughly documented and fully traceable.
The Validation Master Plan (VMP) has clearly outline the validation strategy, define roles and responsibilities, and describe interfaces with the quality system.
Continual Monitoring & Improvement:
Once validated, systems and processes have monitored (through periodic review, trending, revalidation, change control) to ensure they remain in a state of control.
The philosophy has encourage identifying opportunities for optimization, refinement or improvement over time.
Intention of Validation (What We Aim To Achieve) :
To demonstrate and document that systems, equipment, utilities, processes, analytical methods, and computerized systems consistently perform as intended—reliably, reproducibly, and within defined limits under routine conditions.
To provide objective evidence that critical attributes, including product quality, safety, and efficacy, are maintained throughout the product lifecycle.
To establish a controlled, auditable, and structured program that integrates with the quality management system, ensuring validation is systematic, not ad hoc, and aligned with GMP expectations.
To ensure that changes, deviations, or new installations are properly assessed through risk evaluation and validated or revalidated before they affect product quality.
To maintain the validated state through ongoing review, trending, and requalification/revalidation, thereby preserving confidence in system performance over time.
Approach to Validation (How We Will Do It):
Scope Definition & Prioritization:
The scope of the Approach to Validation is to inventory and classify all systems, equipment, utilities, processes, methods, and computerized systems that may impact product quality.
A risk assessment is conducted to categorize these based on their criticality, impact, complexity, and validation requirements.
A validation matrix or schedule is maintained, detailing what has been validated, along with the timing, methodology, and responsible personnel.
Phased Validation Strategy:
Qualification Stage: This stage applies to facilities, utilities, equipment, and instruments. It includes the following phases:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Process Validation: Following the qualification stage—once equipment, methods, and environmental conditions are ready—Process Performance Qualification (PPQ) or Process Qualification is performed. This involves product runs, challenge tests, and worst-case scenarios to demonstrate process consistency and reliability.
Analytical Method Validation / Verification: Validation is performed for analytical methods used in quality control (QC) or product release to ensure they are suitable for their intended use.
Verification is conducted for established methods (e.g., pharmacopoeial methods) when applied to a new matrix or under new conditions.
Computerized System Validation (CSV): CSV is performed in a controlled manner and includes:
User Requirements Specification (URS)
Risk Assessment
System Configuration
Testing (IQ/OQ/PQ or equivalent)
Final System Acceptance
Protocol → Execution → Reporting :
Each validation activity shall be perform by a protocol that defines objectives, scope, responsibilities, acceptance criteria, test plans, sampling, statistical approach, deviations, change control.
Execution of validation activity shall be follow the protocol any deviations must be documented, justified, assessed for impact, and approved.
A validation (qualification) report should be collate results, compare against acceptance criteria, analyze deviations, draw conclusions, and recommend actions or improvements.
Use of Statistical Tools, Reproducibility & Scientific Justification :
Validation activities are planned and executed based on sound scientific rationale, supported by data and justified assumptions. Results must be reliable, consistent, and reproducible under routine operating conditions.
Statistical analysis, trend analysis, and capability assessments shall be utilized to support conclusions, where applicable.
Worst-case conditions, boundary testing, and stress/robustness testing shall considered to effectively challenging the system.
Change Control, Deviation Management & Revalidation :
Any changes to validated systems/processes shall be evaluated via change control, the need for revalidation or partial validation is determined by risk assessment.
Deviations during validation or routine operation shall be investigated, assessed for impact, documented, and corrective/preventive actions taken.
Periodic revalidation or requalification shall be planned, especially for critical systems, or after major changes.
Lifecycle Monitoring ,Review Ongoing Process Verification and Revalidation :
The Validation Master Plan (VMP) shall be periodically review after every three years, and be updated through formal change control, and reauthorized as necessary.
A validated state must be maintained through continued process verification, routine monitoring, change management, deviation handling, trending, control charts, and in-process checks and revalidation when required.—is essential to ensure the system remains in a state of control.
Documented Evidence:
All validation efforts are documented in a structured and traceable manner. Documentation includes protocols, test plans, raw data, deviations, final reports, and ongoing monitoring data.
Roles and responsibilities of relevant personnel :
Validation is a multidisciplinary activity requiring collaboration across departments. Clear assignment of responsibilities ensures proper planning, execution, review, and maintenance of validated systems.
The VMP should explicitly define roles and responsibilities of quality, operations, engineering, validation team, IT, and management.
Adequate resources (personnel, budget, time, instrumentation) must be committed for timely execution.
Oversight by quality assurance and senior management is essential to maintain independence, compliance, and integrity.
Senior Management / Site Head :
Approves the Validation Master Plan (VMP) and ensures alignment with corporate and regulatory expectations.
Ensures adequate resources (personnel, budget, equipment, time) are available for validation activities.
Promotes a culture of quality and compliance across departments.
Holds ultimate responsibility for compliance with WHO GMP standards.
Quality Assurance (QA) :
Owns and maintains the Validation Master Plan.
Ensures all validation activities are planned, approved, executed, reviewed, and archived per regulatory and internal requirements.
Reviews and approves validation protocols, reports, and deviations.
Participates in risk assessments and change control evaluations related to validation.
Ensures that validation activities are auditable and in compliance with GMP.
Provides independent oversight to maintain data integrity and regulatory compliance.
Validation Team / Validation Department:
- Develops validation strategies and schedules.
- Prepares validation protocols (IQ, OQ, PQ, PPQ, CSV, cleaning validation, etc.).
- Coordinates and executes validation testing and data collection.
- Evaluates and documents deviations, justifications, and corrective actions.
- Prepares and finalizes validation reports.
- Maintains validation documentation and supports regulatory inspections.
Engineering / Maintenance:
- Participates in the design, installation, commissioning, and qualification of equipment and utilities.
- Supports execution of Installation Qualification (IQ) and Operational Qualification (OQ).
- Ensures that preventive maintenance and calibration programs are in place and up to date for validated systems.
- Assists in troubleshooting equipment during validation execution.
Production / Manufacturing:
- Supports the execution of Validation i.e. Performance Qualification (PQ) and Process Validation (PV).
- Operates equipment and processes according to validated parameters.
- Reports deviations during validation runs and routine production.
- Participates in training related to validated procedures and processes.
- Maintains process discipline and consistency post-validation.
Quality Control (QC):
- Performs analytical testing related to validation samples (e.g. cleaning validation, process validation).
- Ensures all analytical methods are validated or verified before use.
- Supports method validation or transfer activities.
- Reports analytical deviations encountered during validation testing.
Information Technology:
- Supports validation of computerized systems in line with Good Automated Manufacturing Practice (GAMP)
- Ensures system configurations, access controls, and data integrity requirements are addressed during validation.
- Assists in preparing and reviewing user requirements, risk assessments, and test scripts (IQ/OQ/PQ).
- Provides support during audits of validated computerized systems.
Regulatory Affairs (as applicable):
- Ensures that validation documentation supports regulatory submissions or variations.
- Provides input on regional and international validation requirements.
- Assists with responses to regulatory agencies regarding validation-related questions.
- Training and Human Resources (HR) :
- Ensures that all personnel involved in validation activities are appropriately trained and qualified.
- Maintains training records and facilitates periodic re-training when procedures change.
Resources to ensure that qualification and validation are performed:
In alignment with the principles outlined in WHO TRS 1019, Annex 3, the organization is committed to providing and maintaining adequate resources to ensure that all qualification and validation activities are conducted in a systematic, timely, and compliant manner.
Human Resources:
Adequate and competent personnel are essential for the planning, execution, review, and approval of validation and qualification activities.
Qualified Personnel:
Staff involved in validation (across QA, validation, engineering, production, QC, IT) must be appropriately trained, qualified, and experienced in validation principles, GMP, and relevant regulatory expectations.
Training Programs:
All personnel involved in validation must undergo training in:
WHO GMP guidelines, including WHO TRS 1019 Annex 3.
Validation lifecycle and documentation.
Risk management principles.
Deviation and change control procedures.
Equipment qualification and process validation techniques.
Computerized system validation, where applicable.
Roles and Responsibilities:
Defined roles and responsibilities (as outlined above in point no. 06) ensure clear accountability and proper coordination among cross-functional teams.
Infrastructure and facilities:
Designated Validation Workspace: Validation teams shall have access to appropriate office space, IT infrastructure, and controlled environments for validation testing.
Validated Instruments: Instruments used during validation (e.g., for sampling, measurement, environmental monitoring) must themselves be calibrated, qualified, and traceable.
Document Control Systems: A document management systems are available and document management and control procedure are well defined in the SOP Document and Data Control to manage and archive validation documentation in compliance with data integrity principles.
Equipment and Utilities :
Availability of Equipment: All equipment, systems, and utilities subject to qualification must be available in a ready-for-use condition, installed as per design, and meet user requirement specifications (URS).
Support from Engineering and Maintenance:
Engineering teams are expected to maintain utilities (e.g. HVAC, purified water, compressed air) and production equipment in a qualified state through calibration, preventive maintenance, and requalification schedules.
Financial and Time Resources
Budget Allocation: Adequate financial resources must be allocated to cover:
Procurement of validation instruments and test materials.
Contractor/consultant services (if applicable).
External laboratory services for specialized testing.
Training and professional development programs.
Software or tools needed for validation (e.g. statistical analysis tools, validation lifecycle management systems).
Project Time Allocation:
Sufficient time must be planned and allocated in project timelines and production schedules to accommodate qualification and validation without compromise.
- External Support (as applicable)
- Third-Party Vendors and Consultants:
All the outsourced, external contractors performing validation activities (e.g. equipment qualification, cleaning validation, software validation) are:
- Qualified and approved vendors.
- Operated under Quality Agreements.
- Audited to ensure compliance with WHO GMP expectations.
Technology Providers / OEMs (Original Equipment Manufacturer):
Equipment and system suppliers may be required to support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and provide documentation (URS, DQ, manuals, etc.) for qualification.
Software and Tools :
Validation Lifecycle Management Tools:
Use of computerized systems for protocol creation, execution, deviation tracking, and report generation is encouraged, provided systems are validated and secure.
Risk Assessment Tools:
Structured templates are available for risk assessments (e.g., FMEA, HACCP, risk ranking) as part of validation planning.
Data Analysis Tools:
Appropriate statistical validated spreadsheets are available for analyzing validation data (e.g., trend analysis, capability studies, control charts).
Quality Management System (QMS) Support :
The program/SOPs are available and governed by the organization’s Quality Management System, which includes:
Change Control Procedures
Deviation and CAPA Management
Document Control and Archiving
Internal Audit Program
Management Review
These QMS components provide the necessary framework to ensure validation activities are conducted in a controlled and compliant manner.
Continuous Improvement
The organization is committed to periodically reviewing and improving resource allocation based on:
Validation outcomes and lessons learned.
Audit findings.
Changes in regulatory expectations.
New product or technology introductions.
Outsourced services (selection, qualification, and management through the life cycle) :
Introduction: In accordance with WHO TRS 1019, Annex 3, all outsourced activities that may have an impact on product quality, safety, or efficacy shall be subject to appropriate control and oversight. This includes but is not limited to services related to validation, qualification, calibration, testing, cleaning, maintenance, transportation, and IT systems. The responsibilities related to outsourced services are clearly define and mentioned in SOP to control throughout the life cycle of the service.