Tag: Revalidation & Change Control

Regulatory Expectations for Periodic Revalidation Frequencies

Regulatory Expectations for Periodic Revalidation Frequencies Regulatory Expectations for Periodic Revalidation Frequencies In the pharmaceutical industry, maintaining compliance with regulatory expectations is crucial for ensuring product quality and safety. Periodic revalidation plays a significant role in lifecycle management, ensuring processes…

Cleaning Revalidation: When Is It Required?

Cleaning Revalidation: When Is It Required? Cleaning Revalidation: When Is It Required? In pharmaceutical and biologics manufacturing, cleaning validation is a critical component to ensure that equipment used in production is maintained in a state of cleanliness that prevents cross-contamination…

Revalidation SOP Template: Periodic, Planned & Emergency Changes

Revalidation SOP Template: Periodic, Planned & Emergency Changes Revalidation SOP Template: Periodic, Planned & Emergency Changes In the pharmaceutical industry, the importance of revalidation cannot be overstated. Revalidation ensures that processes remain in a state of control, fulfilling regulatory requirements…

How to Document Revalidation Justifications in QA Systems

How to Document Revalidation Justifications in QA Systems How to Document Revalidation Justifications in QA Systems The validation lifecycle in the pharmaceutical industry is a critical process that ensures product quality and compliance with regulatory requirements. This article serves as…

When to Perform Full vs Partial Revalidation

When to Perform Full vs Partial Revalidation When to Perform Full vs Partial Revalidation In the pharmaceutical and biologics industries, the integrity of manufacturing processes is paramount. As part of the validation lifecycle, understanding when to perform full versus partial…

Differences Between Requalification and Revalidation

Differences Between Requalification and Revalidation Differences Between Requalification and Revalidation Understanding the distinctions between requalification and revalidation is critical for maintaining compliance with regulatory standards in the pharmaceutical industry. This article outlines a structured approach to process validation in pharma,…

Product Change Revalidation Checklist for Multi-Product Facilities

Product Change Revalidation Checklist for Multi-Product Facilities Product Change Revalidation Checklist for Multi-Product Facilities In the pharmaceutical industry, process validation is a vital component that ensures the quality, safety, and efficacy of drug products. The transition from one product to…

Revalidation After Process Changes: What Needs to Be Done

Revalidation After Process Changes: What Needs to Be Done Revalidation After Process Changes: What Needs to Be Done In the pharmaceutical industry, maintaining compliance with regulatory standards is paramount. The validation processes involved are vital to ensuring product quality and…

Periodic Revalidation: Frequency, Requirements, and Templates

Periodic Revalidation: Frequency, Requirements, and Templates Periodic Revalidation: Frequency, Requirements, and Templates Periodic revalidation is an essential aspect of the lifecycle of process validation in the pharmaceutical industry. This article offers a comprehensive, step-by-step tutorial on the validation lifecycle, ensuring…

What Triggers Revalidation in Pharma? A Complete Guide

What Triggers Revalidation in Pharma? A Complete Guide What Triggers Revalidation in Pharma? A Complete Guide In the pharmaceutical industry, maintaining the quality and integrity of products is critical throughout their lifecycle. Process validation encompasses multiple stages, including design, qualification,…