cGMP (ISO13485:2016) – Validation Master Plan (VMP)

Rami.Azulay April 18th, 2019 Posted by Rami Azulay( ) e-GMP

Part of the GMP,  a Validation Master Plan (VMP) is a way to clearly define or layout the requirements for process validation and the justification for those validations to better help medical device manufacturers. Organizations seeking control or methodology to a specific process, often make use of a validation master plan.

An integral part of a company’s Quality Management System especially if the company specialized in biotechnology, pharmaceutical, and medical device manufacturing, is the validation of their process, product, and facility.

The VMP differs from the Standard Operational Procedure (SOP). VMP is used to prioritize objectives, makes plans on the steps to take for a particular procedure while getting the steps ready for approval. On the other hand, the (SOP) showcases the exact procedure to follow to complete approved tasks. Also, the VMP records the total work put into supporting a process, and it includes; apparatus, benefits, activity, prerequisite, and strategy.

Although, by FDA Quality System Regulation (21 CFR 820), Validation Master Plan (VMP) does not require a formal prerequisite. However, it is beneficial to have a top quality VMP to execute an efficient procedure validation program.

What is Validation Master Plan?

A Validation Master Plan is part of the Good Manufacturing Practices (GMP) requirement as it pertains to biotech, medical device companies, and pharmaceuticals. The VMP is a report that chronicles and stipulate methods and equipment that require approval, the reason they are needed and the plan to ensure that a particular process is completed. Also, the person responsible for the validation process is mentioned in the report.

Owning a VMP will go a long way in ensuring that you can overcome several difficult scenarios that are sure to come up in very regulated areas.  FDA auditors requesting for detailed documentation or procedures, equipment, and validation plan is not uncommon in the industry. While, it isn’t a formal request to have a validation plan, having one prepare will reduce the chances of attracting a warning letter from the FDA.

The Purpose of a Validation Master Plan

The life cycle of the manufacturing validation process is discussed in the VMP, and it best to integrate the legal paper with the VMP to better improve the overall outcome. Likewise, VMP can be regarded as a project planning tool.

The VMP proofs to be beneficial in prioritizing goals, predicting the necessary capital, provide insights and timeline for specific projects. In addition to that, the VMP helps to track effort and document approval status for products, various activities, equipment, benefits, activities, and prerequisite.

Finally, the VMP helps to keep an overall agreed upon record for instrument approval system and general procedures. The plan can be easily given to controllers to justify approval impacts. Also, medical device manufacturers can leverage on the VMP to show that they manufacture medical devices with the focus on quality while ensuring that the manufacturer bears the responsibility for the manufacturing system quality.

What Makes UP a Validation Master Plan?

Ideally, the VMP should consider risk and include the likely effects of the current manufacturing practice on product quality. In so doing, the VMP will be able to pinpoint the procedures that require approval and in what order the validation be executed.

Risk assessment does help identify which procedures that do not need approval, using Orcanos RISK management system. Therefore, it is important to survey and examine the effect of each manufacturing process has on the quality of the final product. If justification is needed for any additional prerequisite and extension that may have been added to the validation, then the VMP can be of help.

What should be in a Good Validation Master Plan?

The Code of Federal Regulations does not have any VMP facts. However, Guidance for Industry has suggested the following be incorporated into a standard VMP;

  • All likely review and simultaneous validation activity.
  • The request, time, area and need for validation activities
  • A report that helps communicate the validation approach to the organization.
  • A detailed account of the timeline, procedures, events, and facilities.
  • Details of departments that have consented to the project.
  • A reference that describes all designs for a validation training program
  • Details on people capable of providing SOPs approval, VMP, conventions, those surveying task, and monitoring tracking systems.
  • There should be details and copies of all approval plans, current SOPs, approval reports, and conventions, pressing strategy records and much more similar information.

Components of a Validation Master Plan (VMP)

  • Table of Contents: Table of contents offers a glimpse into what in the VMP, the critical areas as well as direction to the relevant data.

Sample TOC:

1   PURPOSE.

2   SCOPE.

3   STANDARDS, GUIDELINES & APPLICABLE DOCUMENTS.

4   INTRODUCTION.

5   METHOD.

6   PROCEDURE.

7   ACCEPTANCE CRITERIA.

8   RESPONSIBILITIES.

9   VALIDATION SUPPORT SYSTEM.

10    LIST OF APPENDIXES.

11    PROCESSES DESCRIPTION.

12    PROCESS VALIDATION DECISION.

13    QUALIFICATION & VALIDATION FLOW DIAGRAM:

14    VMP TRACKING SCOPE.

15    APPENDIX NO.2 ABUTMENT PRODUCTION FLOW CHART.

  • Authorization and Title Page (dates with approval signatures): The title page will have document number, version, the title, clearly defined management agreement s and QA, these are provided automatically by Orcanos eDMS system for Document Control.
  • Validation Plan: The VMP will help identify why validation is required, what should be validated, where, when and how the validation should be done. The plan will also include a step of procedures broken into the section as well as which methods are vital to the project.
  • Abbreviations and Glossary: Technical terms and organization terminologies will be explained in this section.
  • Approach and Purpose of Validation: The purpose of the VMP clearly states with supporting logical statements the validation approach. The document must be detailed and concise to make for a comfortable and comprehensive read for the end users. The reason for the VMP’s showing of frameworks, procedures, equipment, and structured execution can be explained by the approval approach. However, the proposal does assure that validations will be executed by the approved protocol that is written. With the assurance of reliable method and arrangements of the framework, change of control and capability I bound to exist. Following this approach, all products are sure to follow a well-documented risk evaluation assessment when it comes to their manufacturing procedure and framework.
  • The Scope of Validation:  Scope covers utilities, systems, processes, procedures, equipment that might impact the final product during manufacturing as it pertains to VMP. Based on the documented risk evaluation, the scope must capture extensively the frameworks, procedures, utilities, and strategies that will be validated. Likewise, who and what should be stated clearly in the scope. It is vital that from start to finish of the VMP, readers can understand the scope.
  • Outsourced Services: In the VMP, services that relate to the management and selection of qualifications, calibrations, and activities performed by a third party.
  • Roles and Responsibilities:  this part of the plan will contain details of the role the VMP department concerning the preparing of validation protocols, change control documents, tasks reports, validation SOPs, maintenance and storage of validation-based documents. VPM will be kept by during manufacturing and designing through convention deviation, approval convention, tasks reports, and control records while the QA will be approving and reviewing protocol deviations, SOPs for consistency with cGMPs, task reports, validation protocols, approval to implement and consistency with procedures and policies.
  • Deviation management invalidation: Methodology for documenting deviations must be addressed in the VMP.  Also, when a deviation occurs during approval, it is to be noted and studied to examine methods or features of the approval convention to determine what corrective action to take and what endorsement for approval should be expected (CAPA), using Orcanos electronics CAPA Management system.
  • Risk management principles in validation: With relations to the validation process, risk management principles should be included in the VMP.  The assessment should cover design, deployment and the entire lifecycle of a planned project, using Orcanos RISK management system according to the ISO 14971:2012.
  • Change Control in Validation: A change management (ECO) system must be in place to cater to any changes that may impact the validated process and be documented in the Validation Master Plan, using Orcanos ECO management software.
  • Training: The VMP must define personnel that would be involved in a project, the qualifications they need and training they must undertake to ensure they perform excellently, using Orcanos Training management system.
  • All Validations: This is the totality of the VMP, and it includes an analytical method, cleaning, processes, equipment, premises, computer validation, qualification, utilities, and revalidation, using Orcanos Validation management system.

A general overview of the details contained in the VMP includes vital areas such as manufacturing areas, central plant, and material storage. Similarly, connections and illustration should be part of the VMP and differentiate between regions, for instances Non-GMP regions against GMP regions. Other things to be considered or incorporated include; general acknowledgment criteria, major advances in hardware, procedure, frameworks and any other changes that need to be part of the VMP.

  • Validation Matrix: The Validation Matrix is to list all the necessary validation throughout the facility. Using a matrix, timelines to execute crucial approvals will be a reality.
  • References: There must be rundown records of all activities, directions, execution, and capabilities in the VMP, using Orcanos traceability tools.

Quality Assurance is top-priority for everyone who is part of the medical industry, hence the need for the Validation Master Plan (VMP). As part of our Orcanos system and services, we handle OQ, IQ, and PQ protocol using the Orcanos testing system. Reports from our system can be generated in any format and data settings. Orcanos eGMP provides full-scale capabilities to allow any organization to conduct it VMP obligations using the Orcanos eFroms system along with its build in process automation infrastructure and increase organization efficiency by 10’s% and reduce risk during the production process.

 

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About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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