Tag: iso 11607 2

Method Validation Report Review Checklist for QA Teams

Method Validation Report Review Checklist for QA Teams Method Validation Report Review Checklist for QA Teams In the field of pharmaceutical validation, adherence to regulatory standards is essential for ensuring product quality and safety. This comprehensive guide focuses on the…

Regulatory Requirements for Analytical Method Validation (ICH Q2, USP )

Regulatory Requirements for Analytical Method Validation (ICH Q2, USP) Regulatory Requirements for Analytical Method Validation (ICH Q2, USP) In the complex landscape of pharmaceutical development, ensuring the reliability and accuracy of analytical methods is paramount. This comprehensive tutorial provides a…

Dead Leg Identification and Correction in Utility Systems

Dead Leg Identification and Correction in Utility Systems Dead Leg Identification and Correction in Utility Systems The identification and correction of dead legs in utility systems are crucial for maintaining regulatory compliance, ensuring product quality, and safeguarding patient safety in…

How to Perform Thermal Mapping of Utility Lines

How to Perform Thermal Mapping of Utility Lines How to Perform Thermal Mapping of Utility Lines The process of thermal mapping utility lines is critical in ensuring that the temperatures throughout controlled environments, such as cleanrooms, meet the regulatory requirements…

Regulatory Guidance on Process Robustness (FDA, EMA, ICH Q/Q)

Regulatory Guidance on Process Robustness (FDA, EMA, ICH Q/Q) Regulatory Guidance on Process Robustness (FDA, EMA, ICH Q/Q) Step 1: User Requirements Specification (URS) and Risk Assessment The foundation of any robust pharmaceutical validation process begins with the User Requirements…

How to Design a Robustness Study During Process Validation

How to Design a Robustness Study During Process Validation How to Design a Robustness Study During Process Validation In the pharmaceutical industry, the assurance of product quality through validated processes is paramount. Process validation involves a thorough assessment of various…