Stage 2 – Process Qualification (PPQ)

How Many PPQ Batches Are Required? Regulatory Views

How Many PPQ Batches Are Required? Regulatory Views How Many PPQ Batches Are Required? Regulatory Views In the pharmaceutical industry, pharmaceutical validation is a critical process that assures the efficacy, safety, and quality of medicinal products. When it comes to…

QA Oversight During PPQ Execution: What to Review

QA Oversight During PPQ Execution: What to Review QA Oversight During PPQ Execution: What to Review Step 1: Understanding the Purpose of Process Performance Qualification (PPQ) The Process Performance Qualification (PPQ) phase is critical within the lifecycle of validation in…

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,…

PPQ Protocol Deviations: Documentation and Justification

PPQ Protocol Deviations: Documentation and Justification PPQ Protocol Deviations: Documentation and Justification Protocol deviations during the Process Performance Qualification (PPQ) stage are not uncommon in the pharmaceutical validation lifecycle. Understanding how to document and justify these deviations is imperative for…

How to Align Stage 2 Validation with Cleaning and Equipment Readiness

How to Align Stage 2 Validation with Cleaning and Equipment Readiness How to Align Stage 2 Validation with Cleaning and Equipment Readiness Pharmaceutical validation is a crucial aspect of ensuring that manufacturing processes produce consistent, high-quality products. Stage 2 validation,…

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…