You’ve probably heard that you must have a validation plan before launching your product.
A validation plan outlines the steps you will take to determine whether or not your product is viable. Creating a validation plan before launching your product is crucial because it can help you avoid costly mistakes.
This post tells you about the validation master plan in detail and its essential elements, examples, and templates.
What is validation master plan (VMP)?
It is a document that describes the overall strategy for validating a process or system. Organizations use it to ensure that their processes and systems comply with quality, safety, and regulatory standards.
It outlines the objectives, scope, approach, and responsibilities of the validation activities. It also includes details on the validation process, tests and assessments, the validation team, documentation requirements, and the acceptance criteria for each stage of the validation.
Why do we need it?
We need this plan to ensure that all validation activities are controlled and organized and to explain why certain validation activities were carried out.
A VMP is a document that outlines the goals, objectives, processes, and methods for validating a product or system. In addition, it is used to define the timeline for validation activities and their planned and expected outcomes.
Essential elements of VMP
This document should include the overall process, any necessary risk assessments, management strategies, and details on validation deliverables, timelines, and milestones.
Some essential parts of a VMP include:
Scope and objectives of the validation
This should outline the system or product to be validated, any applicable regulatory requirements, and the desired outcome.
Regulatory compliance requirements
This should include all relevant regulations that need to be met to ensure compliance with local laws.
Validation strategy
This should outline the approach that will be taken to validate the system or product, such as whether it will include a software validation or performance qualification. It should also detail any risk management strategies and how they will be implemented.
Validation deliverables
This should include all documents required for each validation stage, such as test plans, protocols, reports, and validation summaries.
Validation timetable
This should set out the timeline for each validation activity, such as when protocols must be written, tests conducted, and reports generated.
Documentation requirements
This should detail any documentation required for system or product validation, such as user manuals and training materials.
Validation review
This should outline the process for verifying and approving validation activities and any other quality assurance checks that need to be performed.
Validation master plan examples
Example 1: Risk-Based validation master plan
For a risk-based this plan, the primary focus is on identifying and mitigating risks. The validation plan aims to identify potential risk areas and develop strategies to reduce or eliminate them.
A typical approach to risk management is to identify the sources of risk, assess the likelihood and impact of each threat, prioritize the risks based on their potential severity, develop plans for mitigating them, and monitor their effectiveness.
Example 2: Quality-Based validation master plan
The primary focus of a quality-based validation plan is on ensuring product quality. In addition, this validation plan aims to ensure that all products meet their required specifications and adhere to regulatory guidelines.
This approach typically includes activities such as developing quality control procedures, identifying potential areas of nonconformity, implementing corrective actions, conducting internal audits, and evaluating the effectiveness of the quality management system.
Example 3: Prototype-Based validation master plan
The primary focus of a prototype-based validation plan is on creating and testing prototypes.
This validation plan typically includes developing specification requirements, designing a prototype, creating a test plan, and conducting tests to evaluate performance and reliability. Following this process helps ensure that the final product meets its intended purpose.
Example 4: System-Based validation master plan
This validation plan’s primary focus is ensuring that all systems working properly. In addition, this validation plan typically includes verifying system requirements, developing test plans, and conducting tests to evaluate the system’s performance and reliability.
After testing, the results can be used to ensure that all systems are functioning correctly.
No matter what type of validation master plan you use, it is important to have a template outlining the activities and tasks involved. A good template should include sections on purpose, process flow, roles and responsibilities, resources needed, deliverables, timelines, and review/approval steps.
What is a validation master plan template?
This template is a tool for creating a customized plan for validating a product, system, or process. It can include information such as the scope of work, timeline, resources needed, risk assessment criteria, quality control procedures, and acceptance criteria.
It can also outline the roles and responsibilities of each team member involved in validation activities.
Here we are providing the outline of the template. That includes
1. Purpose
To document the overall validation strategy and to determine the necessary tasks to validate facilities, utilities, equipment, process, and product.
2. Scope
To define the scope of validation activities, including company, buildings, and products.
3. Responsibility
To define the roles and responsibilities of the validation team members or departments.
4. Standard operating procedures (SOPs)
To guide and support validation activities. The list of SOPs are
- Validation SOPs
- Metrology, facilities, and engineering SOPs
- Quality control SOPs
- Quality assurance SOPs
5. Validation overview
To provide overall product quality assurance. The validation process defines how the entire manufacturing system is consistent and reliable.
The types of validation to reach the manufacturing process validated state are Equipment, Utilities, Facilities, Computer systems, Cleaning, Sterilization, Methods, and Process.
- 5.1 Installation qualification
- 5.2 Operation qualification
- 5.3 Computerized system validation
- 5.4 Performance qualification
- 5.5 Method validation
6. Product validation
To define the validation activities for each product. After the facility, utility, and equipment validation, the manufacturing process should be validated to check whether the products meet the final product specification.
All the parameters like manufacturing time, room temperature, product temperature, and equipment settings will be mentioned.
7. Process description
You need to describe your process here. Sampling tests of the in-process and final products will be documented. Here validation of the initial process will occur by doing three studies of each product formulation and filling/packaging configuration.
That will ensure that all pre-determined in-process and final product specifications are met, providing an accurate measure of variability among successive runs.
All documents related to manufacturing products will be kept for assessment and used as part of the decision-making process for releasing products.
8. Validation scheduling and control
It refers to the completion of scheduled validation of equipment, services, and systems. After equipment installation and system construction, appropriate documentation and change control systems are established.
Documentation of standard operating procedures, calibration, qualification/validation protocols, batch records, training, and preventive maintenance help the validation process.
9. Facility validation
It includes warehousing, facility cleaning validation, microbial contamination prevention and control, and environmental monitoring.
10. Utility validation
It includes Heating Ventilation & Air Conditioning System, WFI Generation and Distribution System, Clean Steam Generation and Distribution System, Nitrogen Gas System, Clean Compressed Air (CCA), Plant Steam, Chilled Water System (CHW), Heating Hot Water System (HHW)
11. Equipment validation
It includes Tanks, Vessels, and Skids, Temperature Controlled Chambers and Rooms (CTUs and CTRs), and Equipment Cleaning & Sterilization Validation
12. Additional things
It includes training, calibration, change control, maintenance of spare parts, logbooks, and checklists
When creating a VMP, it is important to consider the product design, intended use, user profiles, and regulatory requirements. The template should be altered to meet the specific needs of the project at hand and may require modifications over time as processes evolve or new regulations are introduced.
A well-crafted VMP template can be a valuable asset in ensuring compliance with applicable standards while saving time and helping to ensure the success of validation activities.
An easy-to-follow template can also streamline communication between team members, making it easier to track progress and identify potential issues before they become major obstacles.
Benefits
Having a validation master plan in place is essential for successfully producing quality products that meet regulatory standards. In addition, it helps to ensure that all validation activities are conducted efficiently and timely and reduces the risk of non-compliance.
Risk management
It provides a systematic approach to assess and manage validation risks associated with the manufacturing process. It identifies potential risk areas and helps identify solutions to mitigate them.
Quality assurance
A VMP provides details on ensuring quality throughout the entire production process, from raw materials through finished products, by establishing standards that each stage of production must meet.
Compliance
The plan helps to ensure that the facility complies with federal, state, and local regulations. It identifies areas where there may be potential non-compliance and guides how to manage them.
Streamlined processes
It helps streamline processes, as all validation activities are documented in one centralized document. That allows for easier and more efficient tracking of validation efforts.
Cost savings
By documenting the steps and processes associated with validating a product or process, it is possible to identify areas where efficiencies can be made and costs reduced. Having a well-defined validation master plan reduces the amount of time spent on validating a product or process.
Conclusion
A Validation Master Plan is essential for ensuring that all validation activities are conducted efficiently and accurately.
By utilizing a VMP template, organizations can ensure that their validation processes are uniform and organized while reducing the risk of errors and ensuring compliance with applicable regulatory standards.
In addition, with a well-crafted template in place, organizations can rest assured that their validation activities are being conducted properly and that any issues or concerns are identified early on.
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