Equipment Qualification

Regulatory Expectations for IQOQPQ in FDA and EU Audits

Regulatory Expectations for IQOQPQ in FDA and EU Audits Regulatory Expectations for IQOQPQ in FDA and EU Audits In the pharmaceutical industry, ensuring that equipment and processes meet defined standards is critical for compliance with Good Manufacturing Practices (GMP). The…

Equipment Qualification Sign-Offs and Final Report Format

Equipment Qualification Sign-Offs and Final Report Format Equipment Qualification Sign-Offs and Final Report Format In the biopharmaceutical and medical device industries, ensuring equipment and systems function correctly and comply with regulatory requirements is fundamental to producing safe and effective products.…

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,…

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…

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…

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…

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…

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…

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…

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,…