Tag: process validation

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…

Executing Stage 2 PPQ: Checklist for Compliance

Executing Stage 2 PPQ: Checklist for Compliance Executing Stage 2 PPQ: Checklist for Compliance In the pharmaceutical industry, ensuring consistent product quality and regulatory compliance is paramount. Stage 2 of the process validation lifecycle, known as Process Performance Qualification (PPQ),…

PPQ in Multi-Product Facilities: Key Challenges and Controls

PPQ in Multi-Product Facilities: Key Challenges and Controls PPQ in Multi-Product Facilities: Key Challenges and Controls In the realm of pharmaceutical development, proper validation processes are fundamental to ensuring therapeutic efficacy and patient safety. Particularly, the Process Performance Qualification (PPQ)…

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…

Process Qualification Failure Handling and CAPA Strategies

Process Qualification Failure Handling and CAPA Strategies Process Qualification Failure Handling and CAPA Strategies In the complex landscape of pharmaceutical manufacturing, ensuring that processes are both validated and compliant with regulations is non-negotiable. This detailed guide focuses on the second…

PPQ Sampling Strategy: How to Justify Sample Size

PPQ Sampling Strategy: How to Justify Sample Size PPQ Sampling Strategy: How to Justify Sample Size The Process Performance Qualification (PPQ) phase in the pharmaceutical validation lifecycle is crucial for ensuring that a manufacturing process is capable of consistently delivering…

FDA vs EMA Expectations for Stage 2 Process Qualification

FDA vs EMA Expectations for Stage 2 Process Qualification FDA vs EMA Expectations for Stage 2 Process Qualification In pharmaceuticals and medical device manufacturing, ensuring validation of processes is crucial for meeting regulatory compliance and ensuring product quality. This article…

Key Elements of a PPQ Report in Pharmaceutical Manufacturing

Key Elements of a PPQ Report in Pharmaceutical Manufacturing Key Elements of a PPQ Report in Pharmaceutical Manufacturing Process Validation is a crucial element in pharmaceutical manufacturing that ensures products meet quality standards and regulatory requirements. This article provides a…