Regulatory Expectations & Global Guidelines

How to Cite Revalidation Strategy in Regulatory Submissions

How to Cite Revalidation Strategy in Regulatory Submissions How to Cite Revalidation Strategy in Regulatory Submissions Step 1: Understanding the Importance of Revalidation In the life cycle of pharmaceutical products, revalidation is a critical component that ensures continuous compliance with…

Periodic Review SOPs with Revalidation Triggers

Periodic Review SOPs with Revalidation Triggers Periodic Review SOPs with Revalidation Triggers In the pharmaceutical and biotechnology industries, ensuring compliance with regulatory standards and maintaining the integrity of validation processes is paramount. This comprehensive guide outlines a step-by-step approach to…

Linking Revalidation to Quality Metrics and CPV Data

Linking Revalidation to Quality Metrics and CPV Data Linking Revalidation to Quality Metrics and CPV Data In the pharmaceutical industry, ensuring product quality and compliance with regulatory requirements is paramount. The validation lifecycle comprises several crucial steps: from process design…

How to Present Revalidation Activities in a Regulatory Audit

How to Present Revalidation Activities in a Regulatory Audit How to Present Revalidation Activities in a Regulatory Audit In the ever-evolving field of pharmaceutical manufacturing, adherence to regulatory standards is of utmost importance. Ensuring the validity and reliability of processes…

Regulatory Requirements for Validation vs Revalidation Terminology

Regulatory Requirements for Validation vs Revalidation Terminology Regulatory Requirements for Validation vs Revalidation Terminology The pharmaceutical industry operates under stringent regulations to ensure the quality and safety of products. Central to these regulations is the validation lifecycle, which encompasses various…

Handling Revalidation for Critical vs Non-Critical Equipment

Handling Revalidation for Critical vs Non-Critical Equipment Handling Revalidation for Critical vs Non-Critical Equipment The revalidation of equipment is a critical aspect of maintaining compliance in pharmaceutical manufacturing environments, particularly concerning the cleaning and environmental control standards outlined in ISO…

Regulator Expectations for Revalidation Frequencies

Regulator Expectations for Revalidation Frequencies Regulator Expectations for Revalidation Frequencies Revalidation in the pharmaceutical and medical device manufacturing sectors is essential for ensuring ongoing compliance with regulatory expectations and maintaining product quality. This article serves as a comprehensive guide to…

Preparing Revalidation Justifications for NDA/ANDA Filings

Preparing Revalidation Justifications for NDA/ANDA Filings Preparing Revalidation Justifications for NDA/ANDA Filings Revalidation is a critical process in the lifecycle of pharmaceutical manufacturing and must be meticulously planned and executed to meet regulatory expectations. This article provides a detailed step-by-step…

Revalidation Practices in EU vs US vs PIC/S Regions

Revalidation Practices in EU vs US vs PIC/S Regions Revalidation Practices in EU vs US vs PIC/S Regions In the pharmaceutical and biologics industry, ensuring the consistency and reliability of processes, equipment, and test methods is of paramount importance. This…

EMA Annex 15 and Its Role in Revalidation Protocol Design

EMA Annex 15 and Its Role in Revalidation Protocol Design EMA Annex 15 and Its Role in Revalidation Protocol Design The pharmaceutical and biologics industry continuously evolves to address stringent regulatory requirements and the rising need for quality assurance. In…