Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-001.00 Effective date: mm/dd/yyyy
Approved by:
• Calibration program summary
• Preventive maintenance program summary
• Key SOPs
• Validation of building
− Test functions and acceptance criteria
− Civil work
− Drainage system
• Validation of utility systems
− Test functions and acceptance criteria
− Plant steam (if applicable)
− Pure steam (if applicable)
− Water for injection (if applicable)
− Compressed air (if applicable)
− Nitrogen (N
2
)/carbon dioxide (CO
2
) (if applicable)
− HVAC
− Emergency power
• Process description
− Process flow, variables, and responses
• Process descriptions
• Qualiication of process equipment
− Test functions and acceptance criteria
• Validation of support processes, for example:
− Washing of components
− Sterilization of components
− Depyrogenation of components
− Aseptic filling validation (media fill studies)
− Cross contamination control
− Computerized pharmaceutical system
• Test functions and acceptance criteria
• QA/QC laboratory validation
− Laboratory equipment qualification
− Computer-related systems in QA/QC
• cGMP procedures and programs
− Engineering change control
− Calibration
− Preventive maintenance program
− Standard operating procedure (SOPs)
− Facility cleaning and sanitization
− Environmental monitoring program
− High efficiency particulate air (HEPA) filter integrity testing (if applicable)
− Filter integrity testing (if applicable)
− Label control program
− cGMP training
− Equipment log book, status tags, and room clearance
− Validation files
− Risk analysis
− Validation schedule
− Validation status
• Drawings/layouts
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