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Elements and Performance Criteria

1. Identify GMP as a regulatory concept
   • Locate sources of information relevant to work role from current Australian and other applicable regulatory frameworks for manufacturing pharmaceuticals
   • Locate sources of information relevant to work role relating to current global harmonisation of GMP compliance and product registrations
2. Identify requirements of GMP related to own work
   • Locate sources of information on GMP requirements in the workplace
   • Identify GMP requirements for pharmaceutical manufacture tasks
   • Confirm specific GMP requirements for own work
   • Identify GMP non-compliant situations and risks to product quality
   • Alert relevant personnel and take appropriate action according to GMP requirements and workplace procedures
3. Complete workplace documentation to support GMP
   • Use workplace procedures to identify GMP requirements for documentation
   • Record information, including calculations and test results according to workplace reporting procedures and GMP requirements
   • Certify records, including electronic records, according to GMP requirements
4. Identify and follow biosecurity requirements
   • Identify information appropriate to work role relating to biosecurity requirements
   • Follow workplace biosecurity requirements and responsibilities related to work role
5. Apply GMP requirements when carrying out work activities
   • Identify common forms of contamination
   • Conduct work according to workplace environmental procedures
   • Maintain workplace cleanliness and tidiness to meet GMP requirements
   • Identify and report signs of unacceptable plant or equipment condition, including calibration status
   • Identify GMP requirements for routinely monitoring work area, materials, equipment and product
   • Complete documentation according to workplace procedures
6. Ensure personal hygiene and conduct meet GMP requirements
   • Maintain personal hygiene to meet GMP requirements
   • Carry out hand washing according to best practice hygiene standards
   • Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
   • Comply with area entry and exit procedures when moving around the workplace
7. Participate in improving GMP
   • Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures
   • Identify elements of GMP that help improve products and processes
   • Implement corrective action within level of responsibility