Validation master plan

Validation master plan is a document that contains information about overall strategy, philosophy, responsibility and intentions toward achieving good performance, quality and effects of validation process. Plan present overall information about entire validation process, organization of validation team, schedule of basic operation, resources needed to perform all activities. It is used in various integrated management systems such as GMP, ISO 9000 and compliance requirements in e.g. pharmaceutical industry. It also contain references to various other documents, reports and data used in integrated management system of the company.

Contents of Validation Master Plan

Validation master plans typically have three main sections.

The first section states how the pharmaceutical or healthcare company's own compliance philosophy and policy address regulatory GxP requirements.

The second section defines the scope of validation, identifying which computer systems require validation. All computer systems whose malfunction could possibly affect the safety, quality, and efficacy (during development or manufacture) or batch tracking (during distribution) of drug products should be validated. A register or inventory of computer system systems to be validated is sometimes attached to the validation master plan as an appendix.

Finally, the third section commits the pharmaceutical or healthcare company to some basic milestones. The milestones are usually associated with the launch of a new drug product but may also be timetabled to satisfy anticipated inspections by GxP regulatory authorities. The milestones demonstrate the pharmaceutical and healthcare company's intent and may be revised during the course of a program of work to reflect changing conditions (G.Wingate, 2016, 87-88)

Structure of Validation Master Plan

The ISPE GAMP Guide suggests the following layout for a validation master plan:

• Introduction and scope
• Organizational structure
• GxP assessment process
• Compliance strategy
• Change control
• Procedures and training
• Document management
• Timeline and resources

In addition, a glossary may be added as required to aid understanding of validation master plan. Bear in mind that not all terms routinely used within the organization will be familiar to those outside it.

Introduction and Scope

Here, reference should be made to relevant policies, and where document fits into level of plannig should be described. The scope and boundaries of the site/area/systems being addressed should be defined as appropriate. Reference should also be made to any subordinate validation plans, and the period within which this plan will be reviewed should be stated.

Organizational Structure

The roles and responsibilities such as ownership, technical support, and QA should be defined. Depending on level of planning, these may be departmental or corporate roles and responsibilities. Individuals should not be named, but their job titles should be identified.

GxP Assessment Process

The computer systems compliance requirement should be explained, including how any prioritization was determined and how any changes in priority will be managed. Identify procedures used in GxP assessment.

Compliance Strategy

The overall computer compliance strategy within validation master plan as well as the life cycle model to be applied and the procedures to be used should be outlined.

Change Control

The approach to change management referring to relvant change control procedures should be mentioned.

Procedures and Training

The training requirements for new and existing SOPs should be described.

Document Management

The contents of compliance packages to be produced should be defined together with the identification of document management and control procedures to be used. Any special requirements need to be specified and clearly understood.

Timeline and Resources

Timeline and resources indicate planned end dates and appropriate intervening milestones, identify resources to be assigned to various activities, and note any critical dependencies that may impact progress. (G.Wingate, 2016, 87-88)

Examples of Validation master plan

• The first example of a Validation Master Plan is the plan from a pharmaceutical company to ensure compliance with the 21 CFR Part 11 regulation. This plan includes an outline of the requirements for data integrity, system validation, and process validation. It also includes a timeline for implementation and resources needed to complete the validation process.
• The second example of a Validation Master Plan is the plan from a medical device manufacturer to ensure compliance with the ISO 13485 standard. This plan outlines the requirements for risk management, design control, and design verification. It also includes a timeline for implementation, resources needed, and methodologies for validating the product.
• The third example of a Validation Master Plan is the plan from a software development company to ensure compliance with the ISO/IEC 25000 standard. This plan includes an overview of the requirements for system design, development, and testing. It also includes a timeline for implementation and resources needed to complete the validation process.

Advantages of Validation master plan

A Validation Master Plan is a comprehensive document that outlines the strategy, philosophy, responsibility and goals of the validation process. It is an essential tool for ensuring the quality and reliability of products and services. The following are some of the advantages of having a Validation Master Plan:

• It provides a clear understanding of the validation process and the strategy for achieving the desired results.
• It ensures that the validation process is carried out in a consistent manner across all areas of the organization.
• It helps to identify potential areas of risk and to develop appropriate validation strategies to address them.
• It creates a common language for validation, allowing teams to work together more effectively.
• It helps to identify areas of potential improvement and to develop processes to address them.
• It provides a framework for documenting the results of the validation process, allowing for easier analysis of data.

Limitations of Validation master plan

Validation master plan is a document that contains information about overall strategy, philosophy, responsibility, and intentions toward achieving good performance, quality and effects of validation process. However, there are several limitations of Validation master plan:

• Validation master plan may not be updated regularly to reflect changes in the regulations, processes or systems.
• It may not be able to keep up with all the advances and changes in technology, which could lead to outdated validation activities.
• It may not provide an adequate description of the validation process and what is expected from each participant.
• It may not have a clear outline of the roles, responsibilities, and timelines of each person involved in the validation process.
• It may not provide adequate guidance on how to assess and monitor the effectiveness of the validation activities.

Other approaches related to Validation master plan

A Validation master plan is a document that contains information about overall strategy, philosophy, responsibility and intentions toward achieving good performance, quality and effects of validation process. Other approaches related to validation master plan include:

• Risk-Based Validation: The Risk-Based Validation approach is used to identify and prioritize potential risks in the validation process. This approach helps to identify areas in the process that need to be addressed and monitored.
• Process Validation: Process Validation is used to ensure that the process is operating in accordance with the design specifications. This includes verifying that the process is producing the intended results in a consistent manner.
• Quality Assurance: Quality Assurance is used to ensure that the validation process is being conducted in accordance with established standards and that the quality of the end product meets the desired specifications.
• Documentation: Documentation is used to provide evidence of the validation process. This includes maintaining records of the process, results and any corrective action taken.

In summary, a Validation master plan is a document that contains information about the overall strategy, philosophy, responsibility and intentions toward achieving good performance, quality and effects of the validation process. Other approaches related to the validation master plan include Risk-Based Validation, Process Validation, Quality Assurance, and Documentation.

Validation master plan — recommended articles

Quality plan — Quality policy — Audit scope — PMBOK framework — Preparation of project — ISO 9004 — Implementation of information security management system — Stages of project — Process validation

References

• Amer, G. (1999). Validation Master Planning: A Practical Guide for Development. Journal of Validation Technology, 5, 118-121.
• Durivage M.A., Mehta B. (2016). Practical Process Validation. ASQ Quality Press.
• Nandhakumar, L., Dharmamoorthy, G., Rameshkumar, S., & Chandrasekaran, S. (2011). An overview of pharmaceutical validation: quality assurance view point. IJRPC, 1, 1003-14.
• Wingate G. (2016). Pharmaceutical Computer Systems Validation: Quality Assurance, Risk ..., Informa Healthcare, 87-88.

Author: Danuta Korzeniak