Operational Qualification: What Parameters to Verify Operational Qualification: What Parameters to Verify Step 1: Understanding the URS & Risk Assessment Operational Qualification (OQ) is an integral part of the validation lifecycle in the pharmaceutical industry, ensuring that equipment operates within predetermined limits and consistently performs its intended function. The first step in this structured process is to establish a solid User Requirements Specification (URS) and conduct a comprehensive risk assessment. The URS outlines the necessary requirements and performance criteria of the equipment based on user needs. It is essential to engage stakeholders such as QA, QC, and production teams to…

Execution of OQ Protocols: Best Practices for Validation Teams Execution of OQ Protocols: Best Practices for Validation Teams In the pharmaceutical industry, ensuring the utmost quality and compliance in manufacturing processes is an ongoing challenge. This article serves as a comprehensive step-by-step tutorial on the execution of Operational Qualification (OQ) protocols, emphasizing best practices aligned with ISO standards, specifically ISO 14644, GxP (Good Practice), and regulatory expectations from organizations like the FDA and EMA. Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The journey of any equipment qualification begins with a thorough understanding of User Requirements Specification (URS)….

Installation Qualification (IQ) Checklist for GMP Equipment Installation Qualification (IQ) Checklist for GMP Equipment In the pharmaceutical industry, ensuring that equipment is qualified to operate consistently and effectively is a critical aspect of compliance with Good Manufacturing Practices (GMP). The installation qualification (IQ) serves as the first step of the validation lifecycle, focusing on equipment setup and its operational conformance with design specifications. This article provides a detailed step-by-step tutorial on IQ, specifically illustrating the significance of continued process verification (CPV) in maintaining compliance over time. The regulatory frameworks provided by FDA, EMA, and ICH emphasize the need for thorough…

What Is Design Qualification (DQ) and Why It Matters What Is Design Qualification (DQ) and Why It Matters In the highly regulated pharmaceutical and biologics industries, achieving compliance with established regulations and guidelines is crucial for delivering safe and effective products. One of the essential steps within this compliance framework is Design Qualification (DQ). This article outlines a comprehensive, step-by-step tutorial on the process validation lifecycle, specifically focusing on DQ, and its interrelation with other validation activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Through this tutorial, we will delve into each phase while aligning…

IQ vs OQ vs PQ: Understanding the Key Differences IQ vs OQ vs PQ: Understanding the Key Differences In the pharmaceutical and biotechnology industries, equipment qualifications play a crucial role in compliance, ensuring that any equipment used in manufacturing processes is fit for purpose. This article outlines a detailed, step-by-step tutorial on the validation lifecycle through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), emphasizing the critical requirements and regulatory expectations as set forth by FDA, EMA, and ISO standards such as ISO 11135. Step 1: User Requirements Specification (URS) & Risk Assessment The first step in any…

How to Write DQ, IQ, OQ, PQ Protocols in Pharma How to Write DQ, IQ, OQ, PQ Protocols in Pharma In the pharmaceutical industry, the validation of equipment and processes is critical for ensuring product quality and regulatory compliance. This comprehensive guide will walk you through the essential steps of the validation lifecycle, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), and Continued Process Verification (CPV). Each phase will be aligned with regulatory expectations from the FDA, EMA, and ICH, providing a clear framework for Quality Assurance (QA), Quality Control (QC), and Validation teams. Step…