Tag: FDA guidelines

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…

Writing a Process Qualification (PPQ) Protocol: Template and Guide

Writing a Process Qualification (PPQ) Protocol: Template and Guide Writing a Process Qualification (PPQ) Protocol: Template and Guide In the pharmaceutical and biologics industries, process validation is essential for ensuring that products are manufactured consistently to meet quality standards. The…

Stage 1 Process Design Review Checklist for Pharma Companies

Stage 1 Process Design Review Checklist for Pharma Companies Stage 1 Process Design Review Checklist for Pharma Companies The validation lifecycle in the pharmaceutical industry is a structured process that ensures that products are produced consistently and meet the required…

Design Input Requirements for Stage 1 Process Development

Design Input Requirements for Stage 1 Process Development Design Input Requirements for Stage 1 Process Development 1. Understanding User Requirements Specification (URS) and Risk Assessment The first step in Stage 1 of the validation lifecycle is the formulation of the…