Root Cause Analysis for Failed Equipment Tests Root Cause Analysis for Failed Equipment Tests In the pharmaceutical industry, rigorous compliance with validation standards is essential to ensure the quality and efficacy of products. An important aspect of this compliance involves conducting a thorough root cause analysis (RCA) for any failed equipment tests, especially concerning analytical method validation. This article will guide you through the entire validation lifecycle with a structured approach, focusing on steps aligned with FDA, EMA, and ICH standards, particularly within the frameworks of FDA’s Process Validation Guidance and EU GMP Annex 15. Step 1: User Requirements Specification…

Protocol Deviations vs Incidents: What’s the Difference? Protocol Deviations vs Incidents: What’s the Difference? In the pharmaceutical industry, ensuring compliance with regulatory standards is paramount. This tutorial serves as a step-by-step guide for QA, QC, Validation, and Regulatory teams, focusing on understanding the distinctions between protocol deviations and incidents within the context of GxP (Good Practice) validation. This guide will navigate through relevant regulatory guidance from the FDA, EU GMP Annex 15, and ICH to equip professionals with practical knowledge necessary for successful validation processes. Step 1: Understanding the Terms and Context The first step in distinguishing protocol deviations from…

Documenting In-Process Changes in Qualification Reports Documenting In-Process Changes in Qualification Reports In the complex landscape of pharmaceutical validation, the ability to navigate through the validation lifecycle with precision and attention to regulatory requirements is essential. This article serves as a comprehensive step-by-step tutorial aimed at Quality Assurance (QA), Quality Control (QC), Validation, and Regulatory teams in the US, UK, and EU regions. We will explore the significant aspects of system validation, particularly focusing on how to document in-process changes during the qualification phase, in alignment with FDA Process Validation Guidance, EU GMP Annex 15, and ICH guidelines. Step 1:…

Deviations During IQ/OQ/PQ: How to Handle Them Deviations During IQ/OQ/PQ: How to Handle Them The validation lifecycle in the pharmaceutical industry is a critical component ensuring that products meet specified requirements for quality and compliance. During installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), deviations may arise that necessitate careful analysis and corrective actions. This article presents a detailed, step-by-step tutorial on handling deviations specifically related to kneat validation, aligning practices with regulatory expectations from the FDA, EMA, and ICH. Step 1: Understanding Objectives and Regulatory Requirements Before beginning any validation activities, it is essential to establish a…

What to Include in a Deviation Log for Qualification Activities What to Include in a Deviation Log for Qualification Activities In the pharmaceutical industry, maintaining compliance with regulatory requirements is paramount for ensuring the quality, efficacy, and safety of products. One crucial element of maintaining compliance is the handling of deviations during qualification activities, particularly in the context of bioanalytical method validation. This article provides a comprehensive, step-by-step tutorial on what to include in a deviation log, ensuring that QA, QC, and validation teams in the US, UK, and EU can adequately document and manage deviations in adherence to GMP…

Writing an Equipment Qualification Protocol: Structure & Format Writing an Equipment Qualification Protocol: Structure & Format The validation of pharmaceutical equipment is crucial to ensure that it meets the requirements for safety, efficacy, and quality. This article presents a step-by-step guide on writing an Equipment Qualification Protocol (EQP) focusing on sterilisation validation, providing practical insights for QA, QC, Validation, and Regulatory teams. The guidance aligns with the requirements outlined in the FDA Process Validation Guidance, EU GMP Annex 15, and ICH guidelines. Step 1: User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle is to…