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  • Writer's pictureNabil Attia

Crafting a Robust Validation Plan in the Pharmaceutical Industry: A Step-by-Step Guide

Validation Manager holding all quality requirements in his hands, and balancing between project and quality teams
Finding a common ground on quality

Navigating the intricate world of pharmaceutical validation often feels akin to an intricate balancing act. On one hand, there are the stringent demands of quality assurance, representing an array of regulatory requirements and obligations. On the other hand, there exist the practical necessities of technical and business teams who are focused on operational efficiency and the successful execution of the project. The key to successfully managing these dual pressures lies in the creation of a robust validation plan.

At its core, a validation plan serves two fundamental purposes:

1. Regulatory Navigation: It enables project teams to navigate the complex landscape of quality assurance regulations. By clearly outlining the validation activities necessary to meet regulatory requirements, it provides a blueprint for compliance. This navigational tool allows teams to uphold the highest standards of quality assurance without being overwhelmed by the often complex and multi-faceted regulatory environment.

2. Bridging the Macro and Microcosm: Furthermore, a validation plan acts as a connective tissue that links the microcosm of individual project activities to the broader macrocosm of the company's established policies, standard operating procedures (SOPs), and working instructions (WIs). In essence, it ensures that your project's validation activities align with the broader quality systems of your organization, creating a seamless alignment between project execution and organizational standards.

Today, we will provide a comprehensive walkthrough of the creation process of this vital tool. By taking you step-by-step through its various sections and details, we aim to illustrate how a well-crafted validation plan can guide your journey towards regulatory compliance while simultaneously ensuring your project aligns with your organization's larger quality assurance framework and operational efficiency goals.

The Purpose

Our journey begins with the purpose of our validation plan, the foundation stone of our document, the reason for our venture. It is a statement that cogently outlines what we intend to achieve with our system or project. While we don't need an exhaustive detail here, it should still offer a solid and concise explanation of the system's intended use.


To ensure everyone involved in the project—ranging from project managers to quality assurance teams—is on the same wavelength, we create a 'Definitions' section. It lists and defines key terms and abbreviations used throughout the document.


A critical aspect of our plan involves defining the 'Scope', including the 'In Scope' and 'Out of Scope' elements of the project and the system. Here, we specify exactly which parts of the project this validation plan covers and which it does not. This boundary setting is essential for managing expectations and safeguarding the project against unwarranted audit complications. To avoid surprises down the line, we need to carefully consider the scope in terms of:

  • Organization/Sites

  • Products

  • System

  • Source Systems

  • Data

  • Business Processes

  • Consummating Applications

  • Qualification / Validation

This categorization helps identify what is included and what isn't.

System Description

Next, we delve into the 'System Description', providing a holistic view of the system. This includes high-level logical system design, data flow and interfaces with other systems, and a comprehensive list and description of all hardware and software components.

Validation Approach

Then we come to the 'Validation Approach', where validation activities align with the standards defined in Computer System Validation (CSV) and Project Management Methedology (PMM). The validation activities detailed here include:

  • Categorization of the System: Identifying the system category according to GAMP 5 guidance, which classifies software from simple systems (Category 1) to highly configurable packages (Category 5). The system's size (small or large) is also determined, influencing the validation deliverables' nature and extent. However, you probably have a guidance for system categorization in your company's CSV SOP.

  • Qualification Plan: If the system involves significant hardware or if the hardware is developed in-house or by a contractor, a qualification plan may be necessary. This plan gives an overview of all architecture layers involved in running the system, delineating how each component will be qualified to ensure its intended function. However, you can create the qualification plan as a separate document or as a part of this document. Depending on how much you have to say.

  • Inventory-ID of the System: This includes the Inventory-ID of the system, as assigned by the process owner per the company's CSV Inventory process. This ID, listed in the Validation Plan, helps track and manage the system throughout its lifecycle.

  • Supplier Assessment: Details any audits or assessments performed on the supplier. If Audits have been performed, they you would need a reference to an Audit database if your company has one, or references to the audit documents themselves, a conclusion as to the outcome and the impact on your validation activities. If no Audits have been performed, then you will have to comply with your company's Supplier Audit SOP in planning the audit activities of your suppliers. These can vary from a simple questionnaire sent and answered by email, or a full fledged Audit on the suppliers premises, with a subsequent Audit report. Also in this case there has to be a conclusion as to the outcome and the impact on your validation activities.

  • Risk Management Strategy: Indeed, it outlines the risk management strategy, implementing a risk-based validation approach. This approach uses a risk assessment to identify and prioritize the areas of the system that pose the greatest risk, enabling the validation efforts to be focused on these areas. The risk management strategy should detail how risks will be identified, assessed, and mitigated. It should also outline how the effectiveness of risk mitigation strategies will be evaluated and how ongoing risk management will be performed throughout the system's lifecycle. Your Company will most probably have a Risk Management SOP, in which case you should refer to it, and only detailing any differences or additions to the SOP you intend to implement here. Remember, the risk-based approach isn't about verifying everything; instead, it's about strategically focusing our efforts where they will provide the most value in terms of mitigating the highest system risks, maintaining product quality, and ensuring patient safety.

Change and Configuration Management

This section ensures the effective management of any system changes and aligns with relevant directives and SOPs for change management and configuration management. The Configuration Management process should describe the system's functions and settings at every phase of its lifecycle. This process begins with the system's installation in the testing environment and ends with the system's decommissioning. An appropriately approved process is necessary, so your company should have one.

Deliverables, Roles, and Responsibilities

Here, we mostly refer to the roles and responsibilities section of the CSV SOP. There, the responsibilities of each role producing the validation deliverables should be listed. If they aren't detailed there or if we are introducing any exceptions, this is the place to list our view. This can be accomplished with a table mapping validation deliverables against roles, where each cell has a C for create, R for review, A for approval, or E for execute. Some cells may have multiple entries.

Deviation Management

Deviation management often remains an understated yet integral part of successful validation. It plays a dual role:

  1. Structured Approach to Issue Resolution: Deviation management stipulates a structured protocol for documenting, classifying, and resolving bugs and issues that may arise during validation. This approach isn't just about tracking bugs—it outlines their lifecycle from discovery to resolution. It also categorizes them based on their severity, providing a clear understanding of which issues are critical and need immediate attention, and which ones are minor and can be resolved in due course.

  2. Guideline for Release Decisions: Beyond just problem-solving, deviation management provides a basis for informed release decisions. It defines the severity classes of issues and dictates which class of bugs can be accepted in a release, and from which level they cannot. This structure helps maintain the balance between progressing in the project timeline and ensuring the software's quality and functionality.

While the validation plan outlines the overarching strategy for deviation management, more granular details might be housed in other documents. For instance, the test plan might delve deeper into the specifics of issue documentation and lifecycle. Alternatively, your organization's Software Development Life Cycle (SDLC) process might have a designated Standard Operating Procedure (SOP) that focuses on deviation management. In such cases, the validation plan would reference these documents to ensure a comprehensive approach to deviation management that aligns with broader organizational processes and guidelines.

Validation Acceptance Criteria

Finally, this section details the criteria from which we can declare the validation as accepted. Below are examples of what this section could look like:

Fulfillment of the following acceptance criteria will be considered an acceptable execution of this plan:

  • The system hardware and software have been installed and documented as per the specifications.

  • The system meets its intended use (i.e., tests and associated test reports are completed and accepted).

  • The processes are up-to-date and adequately describe how the computerized system will be operated.

  • Any exceptions to this plan are justified, and outstanding issues are documented and evaluated.

  • Training has been completed and documented for those who require system access.

  • The documents have been reviewed and approved as defined in roles and responsibilities.

The validation plan stands as a beacon in the pharmaceutical industry, illuminating the path between the twin towers of quality assurance and project implementation. It achieves a dual purpose:

  1. Balancing Act: The plan deftly navigates the tension between the rigorous demands of regulatory compliance and the pragmatic requirements of technical and business teams. It enables organizations to uphold the stringent quality standards necessary in the pharmaceutical world without hampering the spirit of innovation and operational efficiency.

  2. Organizational Connect: The validation plan provides a crucial link between the individual project's validation activities and the overarching policies, standard operating procedures (SOPs), and work instructions (WIs) that govern the organization. It helps ensure that the project aligns with the larger organizational ecosystem and that validation efforts are harmonized with broader company goals.

With this comprehensive roadmap in your arsenal, you are primed to confidently traverse the landscape of pharmaceutical validation. It’s no longer a precarious tightrope walk, but a well-charted journey towards your project goals, firmly grounded in regulatory compliance and company policies. The validation plan transforms the validation process from a daunting task into a streamlined, manageable, and successful endeavor.

The Validation plan should help finding the balance between quality and budget requirements.
Finding equilibrium

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