Revalidation & Change Control

Sample Revalidation Report and Review Flowchart

Sample Revalidation Report and Review Flowchart Sample Revalidation Report and Review Flowchart Revalidation in the pharmaceutical industry serves a critical role in ensuring that processes remain in a state of control throughout their lifecycle. This article outlines a structured approach…

Revalidation Approval Matrix for QA, Validation, and Engineering

Revalidation Approval Matrix for QA, Validation, and Engineering Revalidation Approval Matrix for QA, Validation, and Engineering In the pharmaceutical and biologics sectors, validation is crucial for ensuring quality, safety, and efficacy. The revalidation process, encompassing the lifecycle of validation from…

Annual Revalidation Review Tracker Template

Annual Revalidation Review Tracker Template Annual Revalidation Review Tracker Template In the dynamic landscape of pharmaceutical validation, the need for a structured process to ensure continued compliance with regulatory standards is paramount. This article serves as a comprehensive guide tailored…

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…