Tag: Qualification Protocols and Deviations

Root Cause Analysis for Failed Equipment Tests

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…

Protocol Deviations vs Incidents: What’s the Difference?

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…

Documenting In-Process Changes in Qualification Reports

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…

Deviations During IQ/OQ/PQ: How to Handle Them

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…

What to Include in a Deviation Log for Qualification Activities

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.…

Writing an Equipment Qualification Protocol: Structure & Format

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…