Questions and Answers on Validation Master Plan (VMP)
Questions 1. The VMP should be:
A. Very detailed and lengthy
B. Brief, concise, and clear
C. A replacement for all SOPs
D. Written only by external auditors
Answer: B
Questions 2. The VMP should not repeat information already documented elsewhere; instead, it should:
A. Omit references
B. Refer to existing documents such as SOPs and validation protocols
C. Create new versions of all documents
D. Replace existing validation reports
Answer: B
Questions 3. The VMP should be agreed by:
A. The marketing team
B. Any one staff member
C. Management
D. External stakeholders only
Answer: C
Questions 4. The Introduction section of the VMP should include:
A. Product pricing
B. Firm’s validation policy and scope of operations
C. Details on sales and distribution
D. Customer complaint history
Answer: B
Questions 5. The Organizational Structure section should define personnel responsibilities for:
A. Budget forecasting
B. Validation work, protocols, reports, and approvals
C. Staff vacation planning
D. Product marketing
Answer: B
Questions 6. The tracking system mentioned in the VMP is intended for:
A. Monitoring inventory levels
B. Reference and review of validation documents
C. Tracking employee attendance
D. Shipping documentation
Answer: B
Questions 7. Training needs in the VMP relate specifically to:
A. Sales training
B. Validation support
C. Customer service techniques
D. Marketing presentations
Answer: B
Questions 8. The Plant/Process/Product Description section should:
A. Replace all technical documents
B. Provide cross-references to other documents and rationale for validations
C. Focus only on financial data
D. List only equipment names
Answer: B
Questions 9. In validation studies, a common principle is to:
A. Avoid stressing the system
B. Challenge processes and systems
C. Test only ideal conditions
D. Ignore worst-case scenarios
Answer: B
Questions 10. The rationale for grouping products/processes should be explained when:
A. Worst-case situations cannot be simulated
B. No validation is required
C. Products are identical
D. Only one product is manufactured
Answer: A
Questions 11. Specific process considerations should highlight:
A. Marketing requirements
B. Critical characteristics that need extra attention to ensure quality
C. Employee performance issues
D. Vendor pricing
Answer: B
Questions 12. Validation activities in the VMP should be summarized in a:
A. Flowchart
B. Budget report
C. Matrix format
D. Marketing table
Answer: C
Questions 13. The validation matrix should include:
A. Only IQ activities
B. Items to be validated, validation extent (IQ/OQ/PQ), and approach
C. Only PQ results
D. Just the names of products
Answer: B
Questions 14. The matrix should also show:
A. Future planning and re-validation activities
B. Employee leave schedules
C. Supplier contact details
D. Storage locations
Answer: A
Questions 15. Key acceptance criteria in the VMP refer to:
A. Budget expectations
B. General criteria for validated items listed in the matrix
C. Customer satisfaction targets
D. Packaging material standards
Answer: B
Questions 16. The documentation format section should:
A. List all customer orders
B. Describe the format for protocols and reports
C. Provide only SOP titles
D. Explain budget approval procedures
Answer: B
Questions 17. Required SOPs in the VMP should be:
A. Hidden for confidentiality
B. Listed
C. Excluded from validation activities
D. Replaced with flowcharts
Answer: B
Questions 18. Planning & Scheduling in the VMP should include:
A. Staffing estimates, equipment needs, and a time plan
B. Sales team assignments
C. Customer outreach schedules
D. Employee holiday calendars
Answer: A
Questions 19. The time plan of the project may be included in:
A. Employee handbook
B. The validation matrix
C. Marketing documentation
D. Vendor qualification files
Answer: B
Questions 20. The VMP must include a commitment to:
A. Increasing production speed only
B. Controlling critical changes to materials, facilities, equipment, and processes
C. Reducing regulatory oversight
D. Eliminating all documentation updates
Answer: B
Questions 21. A manufacturer should have a validation master plan that:
A. Is lengthy and highly detailed
B. Reflects the key elements of validation
C. Focuses only on equipment validation
D. Is optional under GMP
Answer: B
Questions 22. The validation master plan should be:
A. Concise and clear
B. Written only by external consultants
C. Updated once every 10 years
D. Confidential and not shared with regulatory authorities
Answer: A
Questions 23. The validation master plan should include approval signatures found on the:
A. Appendix page
B. Title page
C. Glossary section
D. Annexures
Answer: B
Questions 24. Which of the following is explicitly listed as part of the VMP contents?
A. Marketing strategy
B. Customer feedback analysis
C. Table of contents
D. Sales forecasting
Answer: C
Questions 25. The validation master plan must include:
A. Abbreviations and glossary
B. Product pricing structure
C. Batch release schedule
D. Annual budget summary
Answer: A
Questions 26. Which item describes the guiding principles behind validation activities?
A. Validation matrix
B. Validation policy
C. Training records
D. Change control
Answer: B
Questions 27. The philosophy, intention and approach to validation should be included in the:
A. Production plan
B. Validation master plan
C. Maintenance report
D. Supplier audit report
Answer: B
Questions 28. The VMP must specify roles and responsibilities of:
A. Customers
B. Regulatory inspectors
C. Relevant personnel
D. Competitors
Answer: C
Questions 29. The validation master plan should identify resources required for:
A. Facility construction only
B. Qualification and validation
C. Market launch activities
D. Packaging design
Answer: B
Questions 30. Outsourced services in the VMP must address:
A. Employee salaries
B. Equipment warranties
C. Selection, qualification, and management through the life-cycle
D. Product marketing
Answer: C
Questions 31. The validation master plan should include documentation such as:
A. Advertising brochures
B. Certificates, protocols, and reports
C. Shipping documents
D. Sales orders
Answer: B
Questions 32. Which of the following is not listed as a type of qualification?
A. Premises qualification
B. Utilities qualification
C. Personnel qualification
D. Market qualification
Answer: D
Questions 33. Establishment of acceptance criteria should be part of:
A. Sales policy
B. Validation master plan
C. Workforce scheduling
D. Vendor selection only
Answer: B
Questions 34. The validation master plan also covers:
A. Retirement policy as part of life-cycle management
B. Waste disposal methods
C. Employee insurance benefits
D. Office cleaning schedules
Answer: A
Questions 35. The validation master plan should be reviewed:
A. Only when new equipment is installed
B. At regular intervals
C. Once every decade
D. Only during audits
Answer: B
Questions 36. Validation generally requires:
A. Rapid execution without planning
B. Meticulous preparation and careful planning
C. No documentation
D. Only financial investment
Answer: B
Questions 37. Validation work should be carried out according to:
A. Informal verbal instructions
B. Randomly assigned procedures
C. Formally authorized standardized working and administrative procedures
D. Manufacturer’s marketing plan
Answer: C
Questions 38. Validation is characterized by a multidisciplinary approach involving:
A. Only production workers
B. Experts from various disciplines such as pharmacists and engineers
C. Only external consultants
D. Only chemical analysts
Answer: B
Questions 39. Which professional group is not explicitly mentioned as part of the multidisciplinary validation team?
A. Pharmacists
B. Engineers
C. Marketing specialists
D. Technologists
Answer: C
Questions 40. Validation work is usually subject to:
A. Flexible and non-urgent timelines
B. No time constraints
C. Rigorous time schedules
D. Seasonal variations
Answer: C
Questions 41. Validation studies are costly because they require:
A. Low-skilled labor
B. Cheap technologies
C. Highly specialized personnel and expensive technology
D. Minimal documentation
Answer: C
Questions 42. The factors described require a structured approach documented in:
A. Annual budget plan
B. Validation Master Plan (VMP)
C. Marketing strategy report
D. Production schedule
Answer: B
Questions 43. The VMP should provide an overview of:
A. Sales projections
B. Entire validation operation, organizational structure, and planning
C. Customer complaints
D. Recruitment activities
Answer: B
Questions 44. The core of the VMP is:
A. The financial budget
B. The company mission statement
C. The list/inventory of items to be validated and the planning schedule
D. The supplier audit summary
Answer: C
Questions 45. A VMP helps management:
A. Focus on marketing strategies
B. Understand time, people, and money required for validation
C. Reduce production cost
D. Avoid regulatory oversight
Answer: B
Questions 46. A VMP helps validation team members:
A. Choose their own tasks
B. Understand their tasks and responsibilities
C. Assign unrelated duties
D. Ignore documentation
Answer: B
Questions 47. A VMP helps GMP inspectors:
A. Verify financial accounts
B. Understand the firm’s approach to validation
C. Evaluate employee behavior
D. Calculate inventory levels
Answer: B
Questions 48. A Validation Master Plan is defined as a document that:
A. Describes only equipment specifications
B. Summarizes the firm’s philosophy, intentions, and approach for establishing performance adequacy
C. Replaces all SOPs
D. Focuses solely on production
Answer: B
Questions 49. The scope of the VMP includes:
A. Only packaging operations
B. All validation activities related to critical technical operations
C. Only administrative activities
D. Only laboratory testing
Answer: B
Questions 50. The VMP must include qualification of:
A. Marketing materials
B. Critical manufacturing and control equipment
C. Cleaning staff
D. Vendor contracts
Answer: B
Questions 51. The VMP should cover:
A. Prospective, Concurrent, Retrospective, and Re-validations
B. Only prospective validation
C. Only retrospective validation
D. Only re-validation activities
Answer: A
Questions 52. For large projects such as constructing a new facility, the recommended approach is to:
A. Skip validation until construction ends
B. Avoid creating any validation documentation
C. Create a separate VMP
D. Use the same VMP for all unrelated projects
Answer: C
Questions 53. In large projects, the separate VMP should be:
A. Excluded from project management
B. Part of the total project management
C. Kept confidential from inspectors
D. Used only after project completion
Answer: B
Questions 54. A Validation Master Plan (VMP) is primarily used to ensure:
A. Faster production cycles
B. Consistent production of high-quality pharmaceutical products
C. Reduced employee workload
D. Increased marketing performance
Answer: B
Questions 55. A VMP outlines a company’s approach to validation across:
A. Only manufacturing personnel
B. All processes, equipment, and systems
C. Only quality control
D. Only documentation
Answer: B
Questions 56. A key purpose of a VMP is to provide a:
A. Financial projection
B. Roadmap for achieving regulatory compliance
C. Sales strategy
D. Customer service plan
Answer: B
Questions 57. VMPs are essential for risk management because they:
A. Eliminate the need for quality control
B. Identify, assess, and mitigate risks
C. Remove change control steps
D. Only focus on equipment risks
Answer: B
Questions 58. One operational benefit of a VMP is:
A. Reduced documentation
B. Prevention of redundancy in validation activities
C. Decreased training requirements
D. Increased product pricing
Answer: B
Questions 59. The Scope section of a VMP describes:
A. Financial needs
B. Systems, processes, and facilities to be validated
C. Supplier qualification
D. Employee vacation schedules
Answer: B
Questions 60. Organizational Structure in a VMP defines:
A. Only top management roles
B. Roles and responsibilities of personnel involved in validation
C. Sales team responsibilities
D. External auditor duties
Answer: B
Questions 61. Validation Strategy includes:
A. IT strategy only
B. Types and approaches to validation
C. Packaging design
D. Environmental sustainability
Answer: B
Questions 62. The Validation Master Schedule includes:
A. Marketing milestones
B. Planned validation activities and re-validation timelines
C. Annual financial budgets
D. Supplier delivery dates
Answer: B
Questions 63. Change Control in a VMP is used to:
A. Approve employee performance reviews
B. Manage changes that affect validated processes
C. Update warehouse storage plans
D. Remove unnecessary SOPs
Answer: B
Questions 64. Risk Assessment in a VMP helps to:
A. Train sales representatives
B. Identify and manage validation-related risks
C. Adjust product pricing
D. Assign employee bonuses
Answer: B
Questions 65. Acceptance Criteria define:
A. Customer expectations
B. Criteria for successful validation
C. Supplier requirements
D. Minimum system specifications
Answer: B
Questions 66. The USFDA bases its validation expectations on:
A. 21 CFR Part 211 and Part 820
B. ISO 14001
C. EU Annex 1
D. MHRA Orange Guide only
Answer: A
Questions 67. The USFDA does not explicitly require a VMP but expects:
A. A high-level project charter
B. A comprehensive validation strategy
C. A marketing validation plan
D. Only equipment validation
Answer: B
Questions 68. USFDA’s 2011 guidance emphasizes:
A. A documentation-only approach
B. A science-based and risk-based approach
C. Elimination of statistical analysis
D. Outsourcing validation
Answer: B
Questions 69. ALCOA principles apply to:
A. Equipment cleaning
B. Data integrity
C. Facility layout
D. Supplier audits
Answer: B
Questions 70. The EU GMP guidelines for VMPs are primarily defined in:
A. Annex 11
B. Annex 15
C. Part 820
D. ICH Q10
Answer: B
Questions 71. A key focus of EU GMP is:
A. Cost reduction
B. Quality Risk Management (QRM)
C. No requirement for change control
D. Elimination of re-validation
Answer: B
Questions 72. Continuous Process Verification (CPV) is emphasized by:
A. USFDA only
B. EU GMP
C. MHRA only
D. ISO standards only
Answer: B
Questions 73. The MHRA’s expectations align closely with:
A. PIC/S only
B. EU GMP
C. USP requirements
D. ISO 17025
Answer: B
Questions 74. A key MHRA focus area is:
A. Minimizing documentation requirements
B. Data integrity and traceability
C. Rapid validation without evidence
D. Eliminating change control
Answer: B
Questions 75. PIC/S promotes:
A. Localized, country-specific GMP
B. Global harmonization of GMP standards
C. Minimal documentation
D. Single-phase validation
Answer: B
Questions 76. PIC/S emphasizes:
A. Eliminating risk assessments
B. Quality Risk Management (QRM) principles
C. Outsourcing validation only
D. Leaving validation to suppliers
Answer: B
Questions 77. USFDA focuses strongly on:
A. Process lifecycle management and data integrity
B. Marketing consistency
C. Packaging design validation
D. Utility validation only
Answer: A
Questions 77. Practical VMP implementation requires:
A. Avoiding multidisciplinary teams
B. Prioritizing validation using risk management
C. Using only manual documentation
D. Ignoring regulatory updates
Answer: B
Questions 78. Training and competency activities are important because they:
A. Reduce production times
B. Maintain awareness of regulatory requirements
C. Eliminate the need for quality assurance
D. Replace documentation
Answer: B
Questions 79. Using technology in validation helps:
A. Reduce data quality
B. Improve documentation management and monitoring
C. Replace validation entirely
D. Lower equipment qualification needs
Answer: B
Questions 80. The ultimate purpose of a VMP is to ensure:
A. Better packaging design
B. Product quality and patient safety
C. Faster distribution
D. Increased sales
Answer: B
Questions 81. A strong VMP ensures compliance, efficiency, and:
A. Higher product prices
B. Consistent quality
C. Reduced regulatory oversight
D. Faster marketing approvals
Answer: B
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.