Tag: equipment qualification

Linking Legacy Equipment to Current SOPs and Workflows

Linking Legacy Equipment to Current SOPs and Workflows Linking Legacy Equipment to Current SOPs and Workflows In the evolving landscape of pharmaceutical manufacturing, maintaining compliance while utilizing legacy equipment presents unique challenges. This article serves as a practical guide for…

Equipment Lifecycle Management: Adding Legacy Equipment

Equipment Lifecycle Management: Adding Legacy Equipment Equipment Lifecycle Management: Adding Legacy Equipment Step 1: User Requirement Specification (URS) & Risk Assessment In the pharmaceutical industry, developing a User Requirement Specification (URS) is the foundational step for successful validation activities. The…

How to Define Criticality for Legacy Equipment

How to Define Criticality for Legacy Equipment How to Define Criticality for Legacy Equipment In today’s highly regulated pharmaceutical landscape, defining the criticality of legacy equipment is essential for maintaining compliance with FDA, EMA, and other regulatory requirements. This tutorial…

Handling Non-Compliant Legacy Equipment: Mitigation Plans

Handling Non-Compliant Legacy Equipment: Mitigation Plans Handling Non-Compliant Legacy Equipment: Mitigation Plans Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The initial stage in the pharmaceutical validation lifecycle involves developing a User Requirements Specification (URS) and conducting a…

Legacy Equipment Documentation Checklist for Audits

Legacy Equipment Documentation Checklist for Audits Legacy Equipment Documentation Checklist for Audits In the pharmaceutical industry, validation is a critical aspect of ensuring that processes, systems, and equipment operate according to intended specifications and regulatory requirements. This comprehensive guide will…

When Is Requalification Required for Legacy Systems?

When Is Requalification Required for Legacy Systems? When Is Requalification Required for Legacy Systems? In the pharmaceutical industry, the validation of legacy systems often presents unique challenges and opportunities. Modern regulatory frameworks have established stringent guidelines that ensure compliance with…

Testing Minimum Requirements for Legacy Qualification

Testing Minimum Requirements for Legacy Qualification Testing Minimum Requirements for Legacy Qualification Legacy equipment poses unique challenges in the pharmaceutical validation landscape, particularly in adhering to regulatory compliance and maintaining product quality. This comprehensive guide aims to equip QA, QC,…

How to Justify Use of Legacy Equipment to Regulators

How to Justify Use of Legacy Equipment to Regulators How to Justify Use of Legacy Equipment to Regulators In the highly regulated environment of the pharmaceutical industry, validation plays a critical role in ensuring product safety, efficacy, and quality. Legacy…

GxP Compliance for Older Equipment: What’s Acceptable

GxP Compliance for Older Equipment: What’s Acceptable GxP Compliance for Older Equipment: What’s Acceptable In the pharmaceutical industry, maintaining compliance with Good Manufacturing Practice (GMP) is critical, especially when dealing with older, legacy equipment. This article provides a thorough, step-by-step…

Dealing with Missing Calibration/Qualification History

Dealing with Missing Calibration/Qualification History Dealing with Missing Calibration/Qualification History In the pharmaceutical industry, validation activities are critical to ensure compliance with regulatory expectations and to maintain product quality. Missing calibration or qualification history for equipment can pose significant challenges…