How to Write a Validation Master Plan? : Pharmaceutical Guidelines

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How to Write a Validation Master Plan?

Validation master plan has all details about all validation programs of the manufacturing facility. It has summary of the validation strategy of the facility including design validation, IQ OQ PQ, cleaning validation, process validation and computerized system validation.
A Validation Master Plan (also referred to as the VMP) is a document which outlines the principles tied to the qualification of a certain facility, defining the systems and areas which need validation and provides a written guideline on how to achieve and then maintain a qualified facility. VMP is basically a summary of the validation strategy. It is a crucial segment of Good Manufacturing Practice regulated pharmaceutical practice because it supports a structural approach to GMP validation projects.

The purpose of a VMP document is to show that all systems, equipment and processes work as intended and to have a validation based on written and already approved protocols. They are sometimes named after their functional areas such as a Software Master Plan or a Site Validation Master Plan.

Validation Master Plan
Having a VMP is of crucial importance for a facility, as Food and Drug Administration inspectors look at Validation Master Plans in order to see whether a certain facility has an organized and well-thought-out validation strategy. That is why a VMP should contain logical reasoning behind every included or excluded system associated with a validation project. The reasoning, of course, has to be based on risk assessment and have good grounds.

The current standard for writing a VMP is GAMP 5. GAMP (short for Good Automated Manufacturing Standard) is a pharmaceutical industry guide specially designed for those involved in the manufacture or use of automated systems. One of the core principles of GAMP is that quality should never be tested on a batch of products; it should rather be incorporated into each and every step of the manufacturing process.
Related: How to Write a Validation Protocol?

Every Validation Master Plan should include:
  • All validation activities (currently performed, future ones and those already completed)- Schedule and priority of validation activities
  • Description of the validation policy of the company
  • An overview of the scope of work, as well as a description of products, facilities and processes- Facility personnel (or management) who agreed on the plan
  • Copies or details of related VMPs, relevant documents/reports/protocols- Personnel responsible for plan approval, review or reference tracking systems
  • Appendices or references to any planned validation training programs
Validation Master Plan should be simple to navigate and understand and therefore split into different sections. The most commonly used outline has the following sections included:

Introduction
As every longer document, the VMP should have an introduction stating the name of the company, location, any subsidiary information, industry served, as well as a reference to the company's quality assurance policy. Some VMPs also include a signed approval, to show, at the very beginning, that the document is valid and is the one used currently.

Scope
Overview of the company's validation range (single-product/multi-product, equipment installation and already installed equipment).

Facility Description
Number of floors, whether the building is new or not, isolation means, special surfaces that affect product quality, as well as raw materials, personnel flow and waste flow all have to be taken into account to prevent cross contamination.- Commissioning While equipment commissioning is usually not a part of validation, it should be included to describe to criteria used to decide which systems will be tested.

Qualification
Criteria used to decide which utilities and equipment will go through the qualification. This section could also include the Final Report and Protocol formats.

Process Validation
Criteria used to decide which utilities and equipment will go through the process validation.

Computerized System Validation
Details of computer validation through an installed control system (PLC- Programmable Logic Controller/ DCS- Distributed Control System) and criteria used to decide which computer systems will be validated.
  • List of Required Procedures and Protocols
  • List of Standard Operating Procedures
  • Utility and Equipment System Description
Details of a certain system, qualification tests proposed for it, and description of the associated acceptance criteria.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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