Tag: gamma sterilization validation

How to Validate Barcode and Serialization Compliance

How to Validate Barcode and Serialization Compliance How to Validate Barcode and Serialization Compliance Validation in the pharmaceutical sector is a critical element to ensure that all processes yield products of the required quality, effectiveness, and safety. This article serves…

Managing Packaging Material Deviations and CAPAs

Managing Packaging Material Deviations and CAPAs Managing Packaging Material Deviations and CAPAs Effective management of packaging material deviations and corrective and preventive actions (CAPAs) is crucial for maintaining the quality and compliance of pharmaceutical products. This article provides a systematic…

Qualification of Cleaning Agents in Multi-Product Plants

Qualification of Cleaning Agents in Multi-Product Plants Qualification of Cleaning Agents in Multi-Product Plants The qualification of cleaning agents in multi-product pharmaceutical plants is a critical aspect of ensuring product safety and efficacy. This comprehensive guide outlines a step-by-step tutorial…

Common Failures in Cleaning Agent Validation and CAPA

Common Failures in Cleaning Agent Validation and CAPA Common Failures in Cleaning Agent Validation and CAPA 1. User Requirements Specification (URS) & Risk Assessment The foundation of any robust validation lifecycle begins with a properly developed User Requirements Specification (URS).…