Tag: eu annex 11

How to Prepare Validation Metrics for a Regulatory Inspection

How to Prepare Validation Metrics for a Regulatory Inspection How to Prepare Validation Metrics for a Regulatory Inspection Validation metrics play a critical role in the pharmaceutical industry, particularly in ensuring compliance with regulatory requirements, including EU Annex 11, FDA…

Real-Time Alarms and Notification Systems in CPV

Real-Time Alarms and Notification Systems in CPV Real-Time Alarms and Notification Systems in CPV In the evolving landscape of pharmaceutical manufacturing, robust process validation has become pivotal in maintaining compliance with evolving regulations. One area of focus is the implementation…

Airlocks and Pass-Through Chambers: Validation Essentials

Airlocks and Pass-Through Chambers: Validation Essentials Airlocks and Pass-Through Chambers: Validation Essentials Ensuring the integrity of aseptic processes in pharmaceutical and biologics manufacturing is critical for compliance with global regulatory standards, including EU Annex 11. Among various engineering controls, airlocks…

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…

Regulatory Expectations for ICH Q9 Implementation

Regulatory Expectations for ICH Q9 Implementation Regulatory Expectations for ICH Q9 Implementation The implementation of ICH Q9 guidance on Quality Risk Management is crucial for compliance in the pharmaceutical and biologics industries. This article will serve as a comprehensive step-by-step…

Acceptance Criteria for Resolution, Tailing, and Theoretical Plates

Acceptance Criteria for Resolution, Tailing, and Theoretical Plates Acceptance Criteria for Resolution, Tailing, and Theoretical Plates Analytical method validation is a critical component of pharmaceutical quality assurance, ensuring that methods used for testing meet the necessary regulatory standards. This article…

Heat Distribution and Mapping in Steam Autoclaves

Heat Distribution and Mapping in Steam Autoclaves Heat Distribution and Mapping in Steam Autoclaves Heat distribution and mapping in steam autoclaves are critical validation processes for ensuring the reliability of sterilization procedures in the pharmaceutical industry. This comprehensive guide will…

Sampling Strategies for Assessing Blend Homogeneity

Sampling Strategies for Assessing Blend Homogeneity Sampling Strategies for Assessing Blend Homogeneity This article provides a comprehensive step-by-step tutorial on sampling strategies for assessing blend homogeneity in pharmaceutical processes, aligned with EU and US regulations including EU Annex 11. It…