Tag: FDA guidelines

Setting Up a CPV Program: Requirements and Tools

Setting Up a CPV Program: Requirements and Tools Setting Up a CPV Program: Requirements and Tools The implementation of a Continued Process Verification (CPV) program is essential for ensuring the consistent quality of pharmaceutical products throughout their lifecycle. CPV enables…

What Is CPV in Pharma? Full Guide to Stage 3 Validation

What Is CPV in Pharma? Full Guide to Stage 3 Validation What Is CPV in Pharma? Full Guide to Stage 3 Validation In the ever-evolving landscape of the pharmaceutical industry, ensuring a consistent and quality product through rigorous validation processes…

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…

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,…

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…

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,…

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…

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…

Incorporating PAT Tools in Stage 2 Process Qualification

Incorporating PAT Tools in Stage 2 Process Qualification Incorporating PAT Tools in Stage 2 Process Qualification Process validation is a critical component of pharmaceutical manufacturing that ensures products are produced consistently and meet required quality standards. Within the validation lifecycle,…

PQ vs PV: Understanding the Differences in Pharma Validation

PQ vs PV: Understanding the Differences in Pharma Validation PQ vs PV: Understanding the Differences in Pharma Validation Validation is a crucial aspect of ensuring that products manufactured in the pharmaceutical industry meet quality standards and regulatory requirements. The concepts…