Skip Navigation Links.

Validation Life Cycle

The Validation Life Cycle refers to the systematic approach followed in the pharmaceutical and medical device industries to validate processes, systems, and equipment. It encompasses a series of activities and stages executed in a logical sequence to ensure that a validated state is achieved and maintained. The Validation Life Cycle is illustrated in the following diagram:

Validation Lifecycle Diagram

Process Design:

This phase involves designing the process or system to meet the desired objectives and specifications. It includes defining process parameters, establishing critical control points, and determining the necessary equipment and resources. The goal is to ensure that the process is capable of consistently producing products that meet quality standards.

Facility / Utilities / Equipment Qualification :

  • User Requirement Specification (URS): This document outlines the requirements of the system or equipment from the perspective of the end-user. It describes the functionalities, performance criteria, and regulatory compliance needed.
  • Design Qualification (DQ): In this stage, the design of the equipment or system is evaluated to ensure it meets the specifications outlined in the URS.
  • Installation Qualification (IQ): IQ verifies that the equipment or system is installed correctly according to manufacturer's specifications and applicable regulations.
  • Operational Qualification (OQ): OQ ensures that the equipment or system operates within established parameters and performs as intended under normal operating conditions.
  • Performance Qualification (PQ): PQ demonstrates that the equipment or system consistently produces results meeting predetermined specifications when operated in a simulated or actual production environment.

Process Performance Qualification:

This phase involves verifying that the process performs effectively and consistently under normal operating conditions. It includes conducting tests, collecting data, and analyzing results to ensure that the process meets predefined acceptance criteria. The aim is to demonstrate that the process is capable of consistently producing products meeting quality standards.

Continuous Process Verification:

Continuous process verification involves monitoring and assessing the performance of the validated process over time to ensure ongoing compliance with quality standards. It includes collecting and analyzing data, identifying trends or deviations, and implementing corrective actions as necessary to maintain process control and product quality. This phase emphasizes the importance of continuous improvement and proactive management of the validated process throughout its lifecycle.

It's important to note that the specific stages and terminology within the Validation Life Cycle may vary based on industry standards, regulatory requirements, and company-specific practices. However, the general concept of planning, qualification, and ongoing verification remains consistent to ensure the integrity and reliability of processes, systems, and equipment in the pharmaceutical and medical device industries.