A Guide to Validation Master Planning

Quality engineering services are geared towards the management, development, operation and maintenance of quality attributes, and are essential for companies of all sizes, since they can help make sure that quality standards and requirements are met across the board.

Validation of products, processes and facilities is an important part of a company’s QMS (Quality Management System), especially for pharmaceutical, biotechnology or medical device manufacturing. While there is no formal need for a Validation Master Plan according to FDA rules, it is often included in quality engineering services for these sectors.

What is a Validation Master Plan and Why Is It Important?

As part of GMPs (Good Manufacturing Practices) for pharma, biotech and medical device companies, a Validation Master Plan (or VMP) is document that outlines and defines which processes and equipment are to be validated, the priority and order in which this will be done, as well as who is responsible for the validation process, etc.

Validation Master Plan can help companies overcome challenges faced in heavily regulated sectors, since FDA inspectors may request documentation summarizing an organization’s process/equipment validation plan. As mentioned above, it’s part of industry GMPs and not a formal requirement, but can help reduce the chances of receiving an FDA warning letter.

What is Included in a Validation Master Plan?

While VMPs are not listed in the Code of Federal Regulations, appropriate “Guidance for Industry” recommendations say that they should include details of:

  • All prospective, concurrent and retrospective validation activities
  • Time, location, priority and order of validation activities
  • A statement describing the validation policy of the company
  • An overview of the organization’s scope of operations, describing the facilities, products and processes
  • Facility management/personnel who have agreed upon the plan
  • Details or copies of any corresponding validation plans, existing SOPs, relevant policy documents and validation reports/protocols, etc.
  • Persons who are responsible and provide approval for SOPs, protocols and the VMP, as well as any review and reference tracking systems
  • References to or appendices detailing any plans for validation training programs

Validation Master Plan: Sections

  • Introduction – A brief overview of the project, which includes the company’s name, location, any applicable division/subsidiary name, the sector/industry it serves, and references to the company’s Quality Assurance Policy.
  • Scope – An outline defining the range and extent of the organization’s validation activities, whether single/multi-product, the installation as well as equipment installed (both existing and new).
  • Facility Description – The facility’s characteristics (whether the building is new, or an extension/remodel), e.g. number of floors, isolation means, access between process and utility systems, cleanroom certification levels, special surfaces/finishes that affect product quality, etc. The focus is on facility design, and personnel flow, raw material, waste flow and design product characteristics need to be studied to reduce cross-contamination risks.
  • Commissioning – While commissioning of equipment, utilities and support systems is not FDA-regulated and typically not part of validation, this section should list the selection criteria used to determine which systems will be tested. This explains to the FDA why certain utilities are not validated (if they don’t affect product quality) and shows that each support system has been thoroughly tested within the anticipated OQ operating range to check for impact on product quality.
  • Qualification – Selection criteria used to decide which equipment and utilities will go through qualification, as well as published guidelines, regulatory references and company policies that affect the selection process. This section may also include final report and protocol formats (with a description of the format or references to existing protocol development procedures), individual IQ/OQ/PQ definitions, and final reports.
  • Process Validation – Selection criteria used to decide which equipment and utilities will go through process validation, as well as published guidelines, regulatory references and company policies that affect the selection process, any cleaning validations needed to verify inter-campaign/intra-campaign cleaning methods, and packaging and sterility validation for finished products.
  • Computer System Validation – Details of computer validation through an installed control system (Distributed Control System/DCS or Programmable Logic Controller/PLC), the selection criteria used to decide which computer systems will go through validation, and the control system’s 21 CFR 11 compliance details (authority checks, secure audit trails, etc.).
  • List of Required Protocols and Procedures – Equipment and utilities represented in a table (which can be used as a “deliverables list” for external validation), as well as the required procedures and protocols. This section defines validation requirements and resource loading for the project, forming the core of the VMP.
  • List of Standard Operating Procedures – Equipment and utilities represented in a table, as well as required standard operating procedures (SOPs), like the section for “protocols and procedures” above. This section can be used to pinpoint the SOP levels (typically operation, maintenance, and cleaning SOPs) that need to be generated for validation.
  • Equipment and Utility System Descriptions – Details of a specific system (aligned with documentation for Basis of Design), IQ/OQ/PQ qualification tests proposed for it, as well as a brief overview of the procedure and selection of associated acceptance criteria (which may change later when qualification and validation protocols are determined, so do not assign numeric-specific acceptance criteria while developing the VMP).
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