Tag: equipment qualification

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,…

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.…

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 vs Process Validation: Key Differences

Equipment Qualification vs Process Validation: Key Differences Equipment Qualification vs Process Validation: Key Differences Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first step in any validation lifecycle, particularly when it comes to equipment qualification (EQ) and…

Handling Deviations During Equipment Qualification

Handling Deviations During Equipment Qualification Handling Deviations During Equipment Qualification In the pharmaceutical industry, equipment qualification is a vital component of the validation lifecycle. This article serves as a detailed step-by-step tutorial on handling deviations during the equipment qualification phases…

QA Review Checklist for IQOQ Documentation

QA Review Checklist for IQOQ Documentation QA Review Checklist for IQOQ Documentation In the pharmaceutical industry, the validation of equipment and processes is critical to ensure product quality, consistency, and regulatory compliance. This step-by-step tutorial provides a comprehensive roadmap for…

Equipment Qualification Sequence: What Comes First?

Equipment Qualification Sequence: What Comes First? Equipment Qualification Sequence: What Comes First? In the pharmaceutical industry, adherence to stringent guidelines and regulations is vital for ensuring product quality and safety. Equipment qualification is a crucial step within the validation lifecycle…