How to create a Validation Master Plan in 5 steps.

CIQA Team Members

 

INTRODUCTION:

The validation master plan (also called VMP) is the most high-level document responsible to describe what, how, and when the validation activities shall be executed in your whole facility or site. The following diagram describes the relationship between the VMP and other validation documents.

validation master plan

FIVE (5) STEPS TO BUILD A VALIDATION MASTER PLAN THAT COMPLIES WITH FDA REGULATORY REQUIREMENTS

The VMP should be a clear and concise document, typically called a protocol, covering the following main steps:

Step 1. Define the facilities, systems, equipment, or processes in the scope of the validation program. (e.g Manufacturing, laboratory equipment, etc.)

Step 2. Describe the validation strategy and status of these facilities, systems, equipment, or processes. (e.g. Prospective, Concurrent, Retrospective approach, etc.)

Step 3. Establish the change control process to be followed and which deliverables shall be required to fulfill them. (e.g. VP, Risk assessments, URS, IQ, OQ, PQ, etc.)

Step 4. Make the planning and scheduling of all validation activities that shall be conducted in your company. (including activities for new systems, activities driven by change, re-validations, confirmations, and periodic reviews)

Step 5. Obtain the management’s approval and commitment that this validation master plan shall have the support to be implemented as planned, established, and scheduled.

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A Validation Master Plan (VMP) should not be confused with any other validation requirements, such as Validation Plan (VP). The main difference is that the validation master plan is for the whole site, instead, the validation plan for a specific system, area, process, or equipment.  For more information about the validation plan (VP) click here,

Why is important the Validation Master PlaFDA logon for an FDA inspection?

Even though it is not mandatory, it is a guide that outlines the validation approach, strategy, and rationale involved in the further and pending qualification activities of your site. It defines what and when the systems shall be validated or revalidated and provides a written schedule program for achieving and maintaining a qualified facility with validated processes managed under change control procedures.

You can demonstrate which validation activities are in process or pending to be executed since the validation master plan serves as a map with the logistic rationale for the next validation steps and efforts.  Also, if you manage many validation documents and activities at the same time, then the VMP can be used as a centralized index about each validation status and condition to be continued by any person.

Top Benefits of a robust validation master plan?

In case, you receive an unexpected audit meanwhile or before complete some validation work, you can present the VMP to demonstrate the due diligence and intention of the company to comply with the validation strategy.

It is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning, and computer validation.

The FDA regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time.

Some sections and information included in a validation master plan:

·         Purpose, Scope, Background

·         Roles and Responsibilities

·         Definitions and Abbreviations

·         Applicable Documents/References

·         Regulatory and Standard related requirements

·         Facilities, Equipment / System / Process Description and Intended Use

·         Planning and scheduling

·         Training Requirements

·         Planned Validation Activities: Validation / Qualification Plan / Approach / Strategy / Deliverables

·         Change Management System and Product Disposition

·         Procedures, Instructions, and Forms – Maintenance Phase

·         Attachments and Appendixes

Three (3) options to create a validation master plan.

Option 1. You can create a great protocol, using a template.

You can download a free sample of a validation master plan template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create for you a customized validation master plan.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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References

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!