Application
This unit of competency describes the skills and knowledge required to identify and implement contamination control measures in a pharmaceutical manufacturing facility.
The unit applies to individuals with specialised skills and knowledge of Good Manufacturing Practice (GMP) requirements who are responsible for overseeing the implementation of cleaning, sanitation, change control and validation programs within pharmaceutical manufacturing operations and have responsibility for the output of others. This includes applying and communicating non-routine technical solutions to predictable and unpredictable problems.
No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.
Elements and Performance Criteria
Elements | Performance Criteria |
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. |
1. Review contamination risks and related control measures to meet GMP requirements | 1.1 Identify hazards that could present contamination risks by type, origin and product association 1.2 Review hazards and risk control measures to confirm they meet GMP requirements 1.3 Conduct risk assessment according to GMP requirements and workplace procedures 1.4 Confirm control measures |
2. Implement procedures used to control risk of cross contamination | 2.1 Identify effective barriers and control systems to minimise risk of cross-contamination according to GMP requirements and workplace procedures 2.2 Conduct in-process and environmental monitoring according to GMP requirements and workplace procedures 2.3 Validate cleaning processes according to workplace procedures 2.4 Confirm line clearance procedures 2.5 Ensure personal hygiene and conduct of personnel in work area meets GMP requirements 2.6 Ensure operators have the skills and knowledge required to apply contamination control measures |
Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential for performance in this unit of competency but are not explicit in the performance criteria.
Skill | Description |
Reading | Interpret key information from in-process and environmental monitoring test results Interpret key information about GMP requirements in workplace procedures relevant to facilitating contamination control |
Writing | Record contamination information in document management systems |
Oral communication | Use appropriate language and communication skills to ensure that contamination management procedures are understood and implemented |
Numeracy | Monitor data to determine instances of contamination according to GMP requirements |
Navigate the world of work | Monitor personnel adherence to GMP requirements and workplace procedures |
Interact with others | Report GMP requirements for contamination management to relevant personnel using required communication method |
Get the work done | Use electronic document management system |
Sectors
Pharmaceutical (PHM)