Tag: Process Capability & Range Justification

Lifecycle Approach to Process Capability Assessment

Lifecycle Approach to Process Capability Assessment Lifecycle Approach to Process Capability Assessment In the rapidly evolving pharmaceutical landscape, demonstrating robust process capability is critical for ensuring product quality, regulatory compliance, and patient safety. This article aims to provide a comprehensive…

Establishing Process Range Based on Validation Data

Establishing Process Range Based on Validation Data Establishing Process Range Based on Validation Data In the pharmaceutical industry, establishing a robust validation lifecycle is critical for ensuring that processes consistently produce quality products. This article serves as a comprehensive guide…

Process Capability Index (Cp & Cpk): Calculations and Interpretation

Process Capability Index (Cp & Cpk): Calculations and Interpretation Process Capability Index (Cp & Cpk): Calculations and Interpretation Validation is a critical component in ensuring that pharmaceutical manufacturing processes meet established specifications consistently within the framework of Quality Assurance (QA).…

How to Justify Process Ranges Using Scientific Data

How to Justify Process Ranges Using Scientific Data How to Justify Process Ranges Using Scientific Data Justifying process ranges is a critical component of validation in quality assurance in pharmaceutical and biologics manufacturing. It involves a systematic approach to determine…

Understanding Process Capability in Pharmaceutical Validation

Understanding Process Capability in Pharmaceutical Validation Understanding Process Capability in Pharmaceutical Validation Process capability is an essential consideration in pharmaceutical validation, especially when aligning with regulatory standards such as ISO 14644-3. This step-by-step guide aims to provide QA, QC, and…