Validation master plan

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Validation master plan
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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)


Author: Danuta Korzeniak