The assessment process must address all of the following items of evidence.
Ability to:
1. Communicate information about GMP requirements and related procedures to others in the work area. This requires demonstration of two-way communication including active listening and constructive response to feedback
2. Provide access to GMP documentation
3. Model personal conduct and work activities to meet requirements of GMP
4. Identify control points in work area and demonstrate monitoring techniques used
5. Support others to identify control points and demonstrate monitoring and control methods
6. Support others to follow GMP procedures. This includes validation procedures within level of responsibility
7. Ensure that appropriate and timely action is taken in response to non-compliance
8. Determine action required to respond to GMP non-compliance within level of responsibility
9. Participate in consultation processes to improve GMP. This may include investigating actual and potential GMP non-compliance
10. Participate in and/or review practices and procedures to prevent or minimise the likelihood of unacceptable performance
11. Ensure that housekeeping standards are maintained and that equipment is in operational order. This may include participating in the management of equipment calibration
12. Monitor the recording of GMP information to confirm that records accurately reflect performance and meet the requirements of the workplace and legislation
Knowledge of:
13. The role of GMP in preventing contamination, its relationship to legislative responsibilities and potential implications of non-compliance
14. GMP arrangements in the workplace. This includes awareness of relevant GMP codes of practice and related workplace policies and procedures to implement these responsibilities
15. The relationship between GMP and the quality system, personnel responsible for designing and managing GMP, personal role to maintain GMP, the role of internal and external auditors as appropriate
16. Procedures followed to investigate contamination events and performance improvement processes
17. Clothing and footwear requirements for working in and/or moving between work areas
18. Current technical and process knowledge required to monitor GMP and participate in investigating GMP non-compliance within level of responsibility. This includes an understanding of common micro-biological, physical and chemical contaminants, conditions under which types of contamination are likely to occur, related control methods and validation procedures and responsibilities
19. Basic concepts of quality assurance including quality specifications, operating parameters, validation procedures and control methods. This includes an understanding of related documentation including Standard Operating Procedures and/or batch instructions
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. It also includes an understanding of the methods used to monitor process control.
21. Purpose and requirements of validation procedures and purpose of equipment calibration
22. Recall and traceability procedures relevant to work area
23. GMP responsibilities and requirements relating to the work area
24. Properties, handling and storage requirements of raw materials, packaging components and final product handled and used in the work area
25. Standards for materials, equipment and utensils used in the work area
26. Procedures for responding to out-of-specification or unacceptable performance/outcomes. This includes procedures for identifying and isolating or quarantining materials or product of unacceptable quality
27. Documentation system and procedures. This includes record keeping to meet both company and legal requirements, procedures for developing and/or reviewing workplace procedures and document control systems used in the workplace
28. Auditing arrangements, roles and responsibilities as they relate to own work responsibilities. This may include an understanding of the purpose and process for internal and external audit processes
29. Appropriate communication skills and techniques to convey information appropriate to audience
30. Housekeeping requirements and responsibilities relating to own work. Where relevant this includes use and storage of housekeeping/cleaning equipment
31. Waste collection, recycling, handling and disposal. This may include handling/disposal requirements for different types of waste such as hazardous waste where relevant
The assessment process must address all of the following items of evidence.
Ability to:
1. Communicate information about GMP requirements and related procedures to others in the work area. This requires demonstration of two-way communication including active listening and constructive response to feedback
2. Provide access to GMP documentation
3. Model personal conduct and work activities to meet requirements of GMP
4. Identify control points in work area and demonstrate monitoring techniques used
5. Support others to identify control points and demonstrate monitoring and control methods
6. Support others to follow GMP procedures. This includes validation procedures within level of responsibility
7. Ensure that appropriate and timely action is taken in response to non-compliance
8. Determine action required to respond to GMP non-compliance within level of responsibility
9. Participate in consultation processes to improve GMP. This may include investigating actual and potential GMP non-compliance
10. Participate in and/or review practices and procedures to prevent or minimise the likelihood of unacceptable performance
11. Ensure that housekeeping standards are maintained and that equipment is in operational order. This may include participating in the management of equipment calibration
12. Monitor the recording of GMP information to confirm that records accurately reflect performance and meet the requirements of the workplace and legislation
Knowledge of:
13. The role of GMP in preventing contamination, its relationship to legislative responsibilities and potential implications of non-compliance
14. GMP arrangements in the workplace. This includes awareness of relevant GMP codes of practice and related workplace policies and procedures to implement these responsibilities
15. The relationship between GMP and the quality system, personnel responsible for designing and managing GMP, personal role to maintain GMP, the role of internal and external auditors as appropriate
16. Procedures followed to investigate contamination events and performance improvement processes
17. Clothing and footwear requirements for working in and/or moving between work areas
18. Current technical and process knowledge required to monitor GMP and participate in investigating GMP non-compliance within level of responsibility. This includes an understanding of common micro-biological, physical and chemical contaminants, conditions under which types of contamination are likely to occur, related control methods and validation procedures and responsibilities
19. Basic concepts of quality assurance including quality specifications, operating parameters, validation procedures and control methods. This includes an understanding of related documentation including Standard Operating Procedures and/or batch instructions
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. It also includes an understanding of the methods used to monitor process control.
21. Purpose and requirements of validation procedures and purpose of equipment calibration
22. Recall and traceability procedures relevant to work area
23. GMP responsibilities and requirements relating to the work area
24. Properties, handling and storage requirements of raw materials, packaging components and final product handled and used in the work area
25. Standards for materials, equipment and utensils used in the work area
26. Procedures for responding to out-of-specification or unacceptable performance/outcomes. This includes procedures for identifying and isolating or quarantining materials or product of unacceptable quality
27. Documentation system and procedures. This includes record keeping to meet both company and legal requirements, procedures for developing and/or reviewing workplace procedures and document control systems used in the workplace
28. Auditing arrangements, roles and responsibilities as they relate to own work responsibilities. This may include an understanding of the purpose and process for internal and external audit processes
29. Appropriate communication skills and techniques to convey information appropriate to audience
30. Housekeeping requirements and responsibilities relating to own work. Where relevant this includes use and storage of housekeeping/cleaning equipment
31. Waste collection, recycling, handling and disposal. This may include handling/disposal requirements for different types of waste such as hazardous waste where relevant