Tag: Legacy Equipment Qualification

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…

What to Include in a Legacy Equipment Qualification Protocol

What to Include in a Legacy Equipment Qualification Protocol What to Include in a Legacy Equipment Qualification Protocol In the pharmaceutical and biotech industries, the qualification of legacy equipment can present unique challenges, particularly in the context of cleaning validation…

Writing a Risk Assessment for Legacy Equipment Validation

Writing a Risk Assessment for Legacy Equipment Validation Writing a Risk Assessment for Legacy Equipment Validation In the pharmaceutical industry, ensuring compliance with regulations and standards is vital to maintaining quality and safety throughout the validation lifecycle. Legacy equipment, often…

Qualification Strategy for Equipment Without URS or Drawings

Qualification Strategy for Equipment Without URS or Drawings Qualification Strategy for Equipment Without URS or Drawings In the pharmaceutical and medical device industry, the qualification of equipment is a critical process that ensures compliance with regulatory standards while maintaining product…

How to Qualify Legacy Equipment in Existing Facilities

How to Qualify Legacy Equipment in Existing Facilities How to Qualify Legacy Equipment in Existing Facilities The qualification of legacy equipment in pharmaceutical and medical device manufacturing facilities is a critical competency for Quality Assurance (QA), Quality Control (QC), Validation,…