iso 14644 1 cleanroom standards

Real-Life Audit Findings Related to KPI Gaps

Real-Life Audit Findings Related to KPI Gaps Real-Life Audit Findings Related to KPI Gaps In the pharmaceutical and biologics industries, adherence to established guidelines and standards is crucial for ensuring product quality and compliance. This requirement necessitates an understanding of…

Risk of Over-Automation in CPV: Maintaining Human Oversight

Risk of Over-Automation in CPV: Maintaining Human Oversight Risk of Over-Automation in CPV: Maintaining Human Oversight In the realm of pharmaceuticals and biologics, the shift towards automation is reshaping processes, particularly within Continued Process Verification (CPV). While automation enhances efficiency,…

Validation of Automated Glove Leak Testing Devices

Validation of Automated Glove Leak Testing Devices The validation of automated glove leak testing devices is a critical aspect of ensuring contamination control within aseptic processing environments. Adhering to ISO 14644-1 cleanroom standards is essential for maintaining the integrity of…

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…

Case Study: Successful ICH Q9 Audit Outcome

Case Study: Successful ICH Q9 Audit Outcome Case Study: Successful ICH Q9 Audit Outcome This article serves as a practical guide for pharmaceutical professionals, detailing the successful application of ICH Q9 principles in the validation lifecycle. Special emphasis will be…

Regulatory Guidance on Method Transfer and Equivalence

Regulatory Guidance on Method Transfer and Equivalence Regulatory Guidance on Method Transfer and Equivalence This article serves as a comprehensive step-by-step guide for pharmaceutical professionals navigating the complexities of method transfer and equivalence aligned with FDA Guidance and other regulatory…

Steam Contact Surface Compatibility and Corrosion Risk

Steam Contact Surface Compatibility and Corrosion Risk Steam Contact Surface Compatibility and Corrosion Risk In the pharmaceutical industry, maintaining the integrity of cleanroom environments is paramount. The adherence to ISO 14644-1 cleanroom standards ensures that cleanrooms remain uncontaminated and conducive…

Risk-Based Approach to Blend Uniformity Validation

Risk-Based Approach to Blend Uniformity Validation Risk-Based Approach to Blend Uniformity Validation In the pharmaceutical industry, ensuring consistent and uniform blending of active pharmaceutical ingredients (APIs) and excipients is critical to product quality and efficacy. This tutorial outlines a validated…