Revalidation & Change Control

When to Revalidate Based on Risk, Not Time

When to Revalidate Based on Risk, Not Time When to Revalidate Based on Risk, Not Time The pharmaceutical industry operates under rigorous standards to ensure product quality and patient safety. A critical component of this quality assurance process is validation,…

Tools to Score and Prioritize Revalidation Activities

Tools to Score and Prioritize Revalidation Activities Tools to Score and Prioritize Revalidation Activities In today’s pharmaceutical landscape, the implementation of systematic validation processes is critical. One key area often demanding particular attention is the revalidation activities, especially concerning compliance…

Linking Continued Process Verification (CPV) to Revalidation Triggers

Linking Continued Process Verification (CPV) to Revalidation Triggers Linking Continued Process Verification (CPV) to Revalidation Triggers In the evolving landscape of pharmaceutical manufacturing, ensuring consistent product quality is of utmost importance. This is particularly true when we examine Continued Process…

Risk Matrix Template for Revalidation Decision Making

Risk Matrix Template for Revalidation Decision Making Risk Matrix Template for Revalidation Decision Making Cleaning validation is an essential aspect of pharmaceutical manufacturing, ensuring that production equipment is free from contaminants that could compromise product quality. The process of cleaning…

Revalidation Justification Using Deviation and Failure History

Revalidation Justification Using Deviation and Failure History Revalidation Justification Using Deviation and Failure History The revalidation process is crucial for maintaining the integrity of pharmaceutical operations, particularly in ensuring compliance with **ISO 14644 4** standards, which pertain to cleanroom environments…

Examples of Risk-Based Revalidation in Multi-Site Operations

Examples of Risk-Based Revalidation in Multi-Site Operations Examples of Risk-Based Revalidation in Multi-Site Operations In the pharmaceutical industry, ensuring the efficacy and safety of products is paramount. This is particularly true in cleanroom environments classified as cleanroom class 1, where…

Using Product Quality Trends to Trigger Revalidation

Using Product Quality Trends to Trigger Revalidation Using Product Quality Trends to Trigger Revalidation In the pharmaceutical industry, maintaining compliance with regulatory standards is paramount for ensuring product quality. The process validation lifecycle comprises several critical steps that can significantly…

Risk-Based Requalification Plan for Facility Systems

Risk-Based Requalification Plan for Facility Systems Risk-Based Requalification Plan for Facility Systems In the pharmaceutical industry, maintaining compliance with regulatory expectations is paramount. The process of validation encompasses various stages, including Process Design, Qualification, Process Performance Qualification (PPQ), Continued Process…

Case Study: Risk-Based Revalidation Saves Time and Cost

Case Study: Risk-Based Revalidation Saves Time and Cost Case Study: Risk-Based Revalidation Saves Time and Cost Step 1: Understanding Process Design and User Requirements Specification (URS) Process validation is a lifecycle that ensures processes consistently produce products that meet predetermined…

How to Use Risk to Justify Delay or Waiver of Revalidation

How to Use Risk to Justify Delay or Waiver of Revalidation How to Use Risk to Justify Delay or Waiver of Revalidation In the pharmaceutical industry, the validation lifecycle plays a critical role in ensuring that processes remain in a…