Tag: Regulatory Expectations & Global Guidelines

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…

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…

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…

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…

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…

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…