The assessment process must address all of the following items of evidence.
Ability to:
1. Locate and follow workplace information relating to GMP responsibilities
2. Maintain personal hygiene consistent with GMP
3. Follow workplace procedures when moving around the workplace and/or from one task to another to maintain GMP
4. Use, store and dispose of appropriate clothing / footwear as required by work tasks and consistent with GMP
5. Carry out relevant checks and inspections as required. This may include visual checks and inspections on equipment and/or raw materials, product, packaging components and processing conditions relevant to own work
6. Identify and respond to out-of-specification or unacceptable conditions or performance. This may include making adjustments within level of responsibility and/or reporting
7. Follow GMP when carrying out work functions
8. Identify and report situations that do or could compromise GMP
9. Handle and/or dispose of out-of-specification or contaminated materials, packaging components/consumables and product, waste and recyclable material according to GMP as required by work responsibilities
10. Maintain the work area in a clean and tidy state
11. Identify and report signs of pest infestation
Knowledge of:
12. The role of GMP in preventing contamination, its relationship to legislative responsibilities and potential implications of non-compliance
13. The relationship between the Code of Good Manufacturing Practice and workplace procedures, systems and processes
14. GMP personnel and their respective responsibilities
15. Personal role, responsibility and accountability for implementing GMP
16. Sources of advice on GMP requirements for own work
17. Personal clothing and footwear requirements for working in and/or moving between work areas
18. Personal clothing use, storage and disposal requirements
19. Common types and sources of contamination that occurs in the work area
20. Control methods and procedures used in the work area to maintain GMP. This includes an understanding of the purpose of control, the consequence if not controlled and the method of control where relevant
21. Monitoring, inspection and checking procedures relating to process control requirements
22. Standards for materials, equipment and utensils used in the work area
23. Evidence of out-of-standard or unacceptable performance
24. Action required in the event of non-compliance
25. Storage and handling requirements for raw materials, packaging components and product relevant to work role
26. Housekeeping requirements and responsibilities relating to own work. Where relevant this includes use and storage of housekeeping/cleaning equipment
27. Waste collection, recycling and handling procedures relevant to own work responsibilities
28. Responsibilities for reporting and recording quality information
The assessment process must address all of the following items of evidence.
Ability to:
1. Locate and follow workplace information relating to GMP responsibilities
2. Maintain personal hygiene consistent with GMP
3. Follow workplace procedures when moving around the workplace and/or from one task to another to maintain GMP
4. Use, store and dispose of appropriate clothing / footwear as required by work tasks and consistent with GMP
5. Carry out relevant checks and inspections as required. This may include visual checks and inspections on equipment and/or raw materials, product, packaging components and processing conditions relevant to own work
6. Identify and respond to out-of-specification or unacceptable conditions or performance. This may include making adjustments within level of responsibility and/or reporting
7. Follow GMP when carrying out work functions
8. Identify and report situations that do or could compromise GMP
9. Handle and/or dispose of out-of-specification or contaminated materials, packaging components/consumables and product, waste and recyclable material according to GMP as required by work responsibilities
10. Maintain the work area in a clean and tidy state
11. Identify and report signs of pest infestation
Knowledge of:
12. The role of GMP in preventing contamination, its relationship to legislative responsibilities and potential implications of non-compliance
13. The relationship between the Code of Good Manufacturing Practice and workplace procedures, systems and processes
14. GMP personnel and their respective responsibilities
15. Personal role, responsibility and accountability for implementing GMP
16. Sources of advice on GMP requirements for own work
17. Personal clothing and footwear requirements for working in and/or moving between work areas
18. Personal clothing use, storage and disposal requirements
19. Common types and sources of contamination that occurs in the work area
20. Control methods and procedures used in the work area to maintain GMP. This includes an understanding of the purpose of control, the consequence if not controlled and the method of control where relevant
21. Monitoring, inspection and checking procedures relating to process control requirements
22. Standards for materials, equipment and utensils used in the work area
23. Evidence of out-of-standard or unacceptable performance
24. Action required in the event of non-compliance
25. Storage and handling requirements for raw materials, packaging components and product relevant to work role
26. Housekeeping requirements and responsibilities relating to own work. Where relevant this includes use and storage of housekeeping/cleaning equipment
27. Waste collection, recycling and handling procedures relevant to own work responsibilities
28. Responsibilities for reporting and recording quality information