Regulatory Expectations & Global Guidelines

FDA, EMA & WHO Guidance on Revalidation Requirements

FDA, EMA & WHO Guidance on Revalidation Requirements FDA, EMA & WHO Guidance on Revalidation Requirements In the pharmaceutical industry, adherence to regulatory requirements for validation is paramount for ensuring that products are consistently produced to a quality standard. This…

Regulatory Differences in Revalidation for Equipment vs Processes

Regulatory Differences in Revalidation for Equipment vs Processes Regulatory Differences in Revalidation for Equipment vs Processes In the pharmaceutical industry, ensuring compliance with regulatory requirements is essential for maintaining product quality, safety, and efficacy. An integral component of this compliance…

What Inspectors Look for in Revalidation Documentation

What Inspectors Look for in Revalidation Documentation What Inspectors Look for in Revalidation Documentation In the pharmaceutical industry, maintaining compliance with regulatory expectations is critical. This full-length tutorial guides QA, QC, validation, and regulatory professionals through the revalidation process, focusing…

21 CFR Part 211 Requirements Related to Change Control and Revalidation

21 CFR Part 211 Requirements Related to Change Control and Revalidation 21 CFR Part 211 Requirements Related to Change Control and Revalidation In the pharmaceutical industry, maintaining the quality and integrity of products throughout their lifecycle is paramount. This necessity…

Examples of Revalidation-Related Observations from FDA 483s

Examples of Revalidation-Related Observations from FDA 483s Examples of Revalidation-Related Observations from FDA 483s In the pharmaceutical and biotechnology sectors, maintaining compliance with regulatory expectations is vital for ensuring product quality and safety. Revalidation and change control processes are central…

How to Align Revalidation with ICH Q9 Risk Management

How to Align Revalidation with ICH Q9 Risk Management How to Align Revalidation with ICH Q9 Risk Management Revalidation is a critical aspect of maintaining compliance in pharmaceutical manufacturing and process control. It ensures that processes remain in a validated…

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…

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…

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…

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…