Equipment Qualification in Pharma: Complete Guide to IQ, OQ, PQ & DQ How to Qualify Equipment in Pharma: Full Guide to IQ, OQ, PQ & DQ 1. Introduction to Equipment Qualification Equipment Qualification (EQ) is a critical aspect of Good Manufacturing Practice (GMP) that ensures all equipment used in pharmaceutical production is installed, operated, and performs according to defined specifications. Before any production or analytical equipment is brought into routine use, it must go through a structured qualification process consisting of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This four-stage approach provides documented evidence…

IQ in Pharma: Documenting and Verifying Equipment Installation How to Perform Installation Qualification (IQ) in Pharma: Step-by-Step Guide to Verifying Equipment Installation Installation Qualification (IQ) is the documented verification that equipment, instruments, or systems have been delivered, installed, and configured in accordance with approved design specifications and GMP requirements. As the first stage in the Equipment Qualification lifecycle (IQ → OQ → PQ), IQ plays a foundational role in ensuring that all future operations rest on a compliant and verified installation. This tutorial-style article provides QA, QC, validation, and regulatory professionals with an end-to-end guide to IQ execution—including protocols, checklist…

OQ Protocols in Pharma: Testing Performance & Compliance Operational Qualification (OQ) in Pharma: How to Test Equipment Performance and Ensure Compliance Operational Qualification (OQ) is the documented verification that equipment, systems, or instruments operate as intended throughout all anticipated operating ranges. Following Installation Qualification (IQ), OQ is the second phase in the validation lifecycle and ensures that all critical functions and controls are tested under simulated or actual operating conditions. This comprehensive guide offers QA, QC, validation, and regulatory teams a structured, regulatory-compliant approach to OQ—covering protocol design, test execution, acceptance criteria, and audit-ready documentation aligned with FDA, EMA, and…

PQ Execution in Pharma: Strategy, Sampling & Acceptance Criteria Performance Qualification (PQ) in Pharma: How to Validate Equipment Under Real Conditions Performance Qualification (PQ) is the final stage in the equipment qualification lifecycle following Installation Qualification (IQ) and Operational Qualification (OQ). PQ confirms that equipment consistently performs as intended under actual process conditions using approved materials, SOPs, and personnel. It is a critical step in ensuring GMP compliance, product quality, and regulatory confidence. This step-by-step guide explains how to effectively execute PQ, build robust protocols, define sampling plans, and establish acceptance criteria aligned with FDA, EMA, and WHO expectations. What…

Design Qualification (DQ) in Pharma: Aligning Equipment Design with GMP Requirements Design Qualification (DQ) in Pharma: Aligning Equipment Design with GMP Requirements Design Qualification (DQ) is the documented verification that the proposed design of a system, equipment, or facility is suitable for its intended purpose, aligns with regulatory expectations, and complies with GMP requirements. DQ is typically the first step in the equipment qualification lifecycle and plays a pivotal role in laying the foundation for successful Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This article provides a comprehensive guide for QA, Engineering, Validation, and Regulatory Affairs teams…

Documenting Equipment Qualification in Pharma: Templates, Records & Audit Readiness Documenting Equipment Qualification in Pharma: Templates, Records & Audit Readiness In the pharmaceutical industry, equipment qualification is not just about installation, operation, or performance testing. What distinguishes a compliant, audit-ready process from an inadequate one is documentation. Regulatory agencies such as the FDA, EMA, and WHO emphasize that “if it’s not documented, it didn’t happen.” This principle underscores the criticality of detailed, accurate, and controlled documentation throughout the equipment qualification lifecycle. This article provides QA, validation, and regulatory teams with an actionable framework to generate and manage qualification documentation from…

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…

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…

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…

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…