Tag: equipment qualification

How to Link URS to DQ and Qualification Activities

How to Link URS to DQ and Qualification Activities How to Link URS to DQ and Qualification Activities In the pharmaceutical industry, ensuring the quality and compliance of manufacturing processes and equipment is of paramount importance. This is especially true…

Common Mistakes in DQ/IQ/OQ/PQ and How to Avoid Them

Common Mistakes in DQ/IQ/OQ/PQ and How to Avoid Them Common Mistakes in DQ/IQ/OQ/PQ and How to Avoid Them Effective validation of equipment is vital for ensuring compliance with regulatory standards within the pharmaceutical industry. This comprehensive guide provides a detailed,…

Writing a Risk-Based IQOQPQ Protocol Template

Writing a Risk-Based IQOQPQ Protocol Template Writing a Risk-Based IQOQPQ Protocol Template Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment In the validation lifecycle of equipment qualification, the process begins with a comprehensive understanding of the User Requirements…

Performance Qualification (PQ) for Pharma Equipment: A Full Guide

Performance Qualification (PQ) for Pharma Equipment: A Full Guide Performance Qualification (PQ) for Pharma Equipment: A Full Guide Performance Qualification (PQ) is a critical step in the overall equipment qualification process within the pharmaceutical industry, ensuring that systems and processes…

Operational Qualification: What Parameters to Verify

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…

Execution of OQ Protocols: Best Practices for Validation Teams

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…

Installation Qualification (IQ) Checklist for GMP Equipment

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…

What Is Design Qualification (DQ) and Why It Matters

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…

IQ vs OQ vs PQ: Understanding the Key Differences

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…

How to Write DQ, IQ, OQ, PQ Protocols in Pharma

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…