Tag: validation in pharma industry

GxP Compliance for Older Equipment: What’s Acceptable

GxP Compliance for Older Equipment: What’s Acceptable GxP Compliance for Older Equipment: What’s Acceptable In the pharmaceutical industry, maintaining compliance with Good Manufacturing Practice (GMP) is critical, especially when dealing with older, legacy equipment. This article provides a thorough, step-by-step…

Data Integrity Controls in PPQ Execution and Reporting

Data Integrity Controls in PPQ Execution and Reporting Data Integrity Controls in PPQ Execution and Reporting In the pharmaceutical industry, robust data integrity controls are crucial for maintaining compliance and ensuring product quality, particularly during Process Performance Qualification (PPQ). This…

PPQ Risk Assessment Template for Multi-Unit Operations

PPQ Risk Assessment Template for Multi-Unit Operations PPQ Risk Assessment Template for Multi-Unit Operations The validation process in the pharmaceutical industry is a critical aspect of ensuring product quality and compliance with regulatory requirements. This article serves as a comprehensive,…

Validation Acceptance Criteria for PPQ: How to Set Limits

Validation Acceptance Criteria for PPQ: How to Set Limits Validation Acceptance Criteria for PPQ: How to Set Limits In the pharmaceutical industry, ensuring that processes are validated is essential for maintaining quality and compliance. This article provides a detailed, step-by-step…