Tag: ISO 14644

Validating International Cold Chain Routes with Variable Conditions

Validating International Cold Chain Routes with Variable Conditions Validating International Cold Chain Routes with Variable Conditions Proper validation of cold chain transport routes is essential for the pharmaceutical industry to ensure that temperature-sensitive products maintain their quality and efficacy during…

Rubber Stopper and Aluminum Seal Qualification Protocol

Rubber Stopper and Aluminum Seal Qualification Protocol Rubber Stopper and Aluminum Seal Qualification Protocol Rubber stopper and aluminum seal qualification are critical in ensuring the integrity and safety of pharmaceutical packaging. This article serves as a comprehensive step-by-step validation tutorial…

Designing HVAC for Non-Sterile vs Sterile Areas

Designing HVAC for Non-Sterile vs Sterile Areas Designing HVAC for Non-Sterile vs Sterile Areas This article provides a comprehensive, step-by-step tutorial on the validation of HVAC systems used in sterile and non-sterile environments, focusing on the compliance requirements outlined in…

Performance Qualification (PQ) vs OQ: What’s the Difference?

Performance Qualification (PQ) vs OQ: What’s the Difference? Performance Qualification (PQ) vs OQ: What’s the Difference? This article presents a detailed step-by-step tutorial on the differences between Performance Qualification (PQ) and Operational Qualification (OQ) in the context of pharmaceutical validation.…

How to Define Product and Equipment Coverage in a VMP

How to Define Product and Equipment Coverage in a VMP How to Define Product and Equipment Coverage in a VMP Establishing a comprehensive Validation Master Plan (VMP) is a crucial step in pharmaceutical and biological manufacturing processes. A well-structured VMP…

Validation Strategy Based on System Criticality Assessment

Validation Strategy Based on System Criticality Assessment Validation Strategy Based on System Criticality Assessment Validation in the pharmaceutical industry is paramount to ensuring product quality and patient safety. This comprehensive guide will outline the step-by-step validation lifecycle including process design,…

Execution of OQ Protocols: Best Practices for Validation Teams

Execution of OQ Protocols: Best Practices for Validation Teams Execution of OQ Protocols: Best Practices for Validation Teams In the pharmaceutical industry, ensuring the utmost quality and compliance in manufacturing processes is an ongoing challenge. This article serves as a…

Risk-Based Approach to Process Development in Pharma

Risk-Based Approach to Process Development in Pharma Risk-Based Approach to Process Development in Pharma The pharmaceutical industry’s adherence to rigorous validation processes is essential for ensuring that products are safe, effective, and manufactured in compliance with regulatory expectations. A critical…

Cleanroom Validation & Microbiological Risk Assessment: A GMP-Compliant Strategy

Cleanroom Validation & Microbiological Risk Assessment: A GMP-Compliant Strategy How to Validate Cleanrooms and Perform Microbiological Risk Assessment in Pharma Introduction Cleanroom validation and microbiological risk assessment are essential components of any GMP-compliant pharmaceutical facility. Cleanrooms support critical manufacturing environments…