Elements and Performance Criteria
- Review contamination risks and related control measures to meet GMP requirements
- Implement procedures used to control risk of cross contamination
- Identify effective barriers and control systems to minimise risk of cross-contamination according to GMP requirements and workplace procedures
- Conduct in-process and environmental monitoring according to GMP requirements and workplace procedures
- Validate cleaning processes according to workplace procedures
- Confirm line clearance procedures
- Ensure personal hygiene and conduct of personnel in work area meets GMP requirements
- Ensure operators have the skills and knowledge required to apply contamination control measures