Revalidation Summary Templates for Audit Submissions Revalidation Summary Templates for Audit Submissions In the pharmaceutical industry, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory expectations is paramount. The process of validation in quality assurance is complex, involving multiple stages that demand meticulous planning, execution, and documentation. This article provides a step-by-step validation tutorial designed for QA, QC, Validation, and Regulatory teams, focusing on aspects of revalidation and change control. This guide emphasizes practical tasks, documentation, and the essential data required for successful validation aligned with FDA, EMA, and ICH guidelines. Step 1: Understanding User Requirements Specification (URS) and Risk…

How to Cross-Reference Change Controls in Revalidation Reports How to Cross-Reference Change Controls in Revalidation Reports In the pharmaceutical industry, ensuring compliance with regulatory requirements while maintaining product quality is of paramount importance. The process validation lifecycle is fundamental in achieving these objectives, particularly in the context of change controls and revalidation reports. This article serves as a step-by-step tutorial for validation professionals on how to effectively cross-reference change controls during revalidation, with specific attention to ISO 14644-1:2015 standards and the relevant regulatory guidelines. Through this comprehensive guide, you will understand key components required in the validation lifecycle and how…

Review and Approval Log for Revalidation Activities Review and Approval Log for Revalidation Activities In the pharmaceutical and biologics industries, ensuring that validated processes remain in a state of control throughout their lifecycle is crucial. This article provides a comprehensive, step-by-step tutorial on the validation lifecycle, focusing on the Review and Approval Log for revalidation activities, emphasizing compliance with FDA Process Validation Guidance, EU GMP Annex 15, and ISO 14644 standards, particularly ISO 14644-3. Step 1: Understanding Regulatory Requirements Before initiating the revalidation process, it is essential to understand the relevant regulatory requirements governing validation activities. Regulatory agencies such as…

Linking Validation Master Plan (VMP) to Revalidation Planning Linking Validation Master Plan (VMP) to Revalidation Planning In the pharmaceutical and biologics industries, a well-structured validation approach is fundamental to ensure compliance with regulatory requirements and to maintain product quality and safety. This article provides a comprehensive step-by-step tutorial on linking the Validation Master Plan (VMP) to revalidation planning, placing particular emphasis on ISO 14644-3 and integrating good manufacturing practices (GMP) as outlined by FDA, EMA, and other relevant regulatory agencies. This guide is tailored for Quality Assurance (QA), Quality Control (QC), Validation, and Regulatory teams in the US, UK, and…

How to Write a Revalidation Protocol After Change Control How to Write a Revalidation Protocol After Change Control In the pharmaceutical and biotechnology industries, validation is a critical process for ensuring product quality, safety, and compliance with regulatory standards. After a change control event, organizations must prepare and execute a revalidation protocol to maintain these standards. This comprehensive step-by-step guide explains how to write a revalidation protocol following change control, specifically aligned with key regulatory requirements, including ISO 17665, ICH Q8–Q10, EU GMP Annex 15, and more. Step 1: Understanding the Change Control Process The change control process establishes a…

QA Responsibilities in Revalidation and Change Approval QA Responsibilities in Revalidation and Change Approval In the pharmaceutical and biologics industries, revalidation and change approval are critical components of ensuring product quality and compliance. These activities require a systematic approach that adheres to regulatory requirements such as FDA Process Validation Guidance, EU GMP Annex 15, and relevant ISO standards, including ISO 17665. This article provides a step-by-step tutorial on the validation lifecycle that focuses on various aspects of revalidation and change approval. 1. Understanding Revalidation and Change Control Revalidation is a regulatory requirement to ensure that any changes made to processes…