Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

FDFPHGMP3A Mapping and Delivery Guide
Monitor the implementation of Good Manufacturing Practice procedures

Version 1.0
Issue Date: March 2024


Qualification -
Unit of Competency FDFPHGMP3A - Monitor the implementation of Good Manufacturing Practice procedures
Description This is a Core unit for pharmaceutical processing. It covers the skills and knowledge required to provide a leadership role in supporting day-to-day implementation of Good Manufacturing Practices (GMP) in a work area. It also involves supporting others to implement the requirements of GMP. This unit applies to those with formal responsibility for others and to those required to model workplace policies and procedures but who have no formal management role.This is a Core unit for pharmaceutical processing. It covers the skills and knowledge required to provide a leadership role in supporting day-to-day implementation of Good Manufacturing Practices (GMP) in a work area. It also involves supporting others to implement the requirements of GMP. This unit applies to those with formal responsibility for others and to those required to model workplace policies and procedures but who have no formal management role
Employability Skills Not applicable.
Learning Outcomes and Application Not applicable.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites Not applicable.
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities
Slides
PPT
Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Ensure others in the work area are able to meet GMP requirements
  • Relevant clothing and equipment appropriate towork requirements are available, functional and correctlyfitted
  • Advice on GMP responsibilities and proceduresis accessible and clearly explained
  • GMP control measures used in the work area canbe identified by those in the work area
  • Mentoring and coaching support is available tosupport individuals/groups to implement GMP and relatedprocedures
  • Training needs are identified and addressedwithin level of responsibility
       
Element: Monitor personal hygiene and conduct of team members in the work area
  • Personal hygiene of work team meets GMPrequirements
  • Clothing is prepared, used, stored anddisposed of according to GMP and workplace procedures
  • Personal movement around the workplacecomplies with area entry and exit procedures
       
Element: Monitor implementation of GMP requirements in the work area
  • GMP procedures in the work area are clearlydefined, documented and followed
  • Non-compliance with identified procedures isreported and addressed within level of responsibility
  • Personal behaviour is consistent withworkplace policies and procedures that support GMP
  • Workplace procedures to control resourceallocation and process are followed to meet GMP requirements
  • GMP non-conformance is identified and reportedaccording to workplace procedure
  • GMP information is recorded to meet workplacereporting requirements
  • The workplace is maintained in a clean andtidy order to meet GMP housekeeping standards
       
Element: Contribute to validation processes
  • Validation practices and procedures arereviewed in consultation with relevant personnel
  • Validation results and issues are identifiedand corrective action taken within level of responsibility
  • Documentation and recording requirements meetGMP code and company requirements
       
Element: Take corrective action in response to GMP non-compliance
  • Processes, practices or conditions which couldresult in non-compliance with GMP are identified and reportedaccording to workplace reporting requirements
  • Corrective action is taken in accordancewithin level of responsibility
  • GMP issues are raised with designatedpersonnel
       
Element: Maintain and improve GMP in the work area
  • Processes or conditions which could result innon-conformance with GMP are identified, reported and correctedwithin level of responsibility
  • Matters raised relating to GMP are promptlyresolved and/or referred to appropriate personnel
  • Effectiveness of control measures aremonitored within level of responsibility
  • Others in the work area are advised of GMPmatters relevant to work role
  • Changes to documentation are proposed inaccordance with workplace procedures to maintain GMP
  • GMP audits are conducted to meet company andlegislative requirements
  • Action is taken to respond to auditrecommendations within level of responsibility
       


Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

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


Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

Not applicable.

The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.

- Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements

- Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes relevant Good Manufacturing Practice (GMP) codes, the Therapeutic Goods Act, labelling, weights and measures legislation and legislation covering environmental management, occupational health and safety, anti-discrimination and equal opportunity

- Responsibility for applying good manufacturing practice relates to the person's work area

- Products/materials handled and stored can include raw materials, packaging components and consumables, part-processed product, finished product and cleaning materials

- Reporting systems may include electronic and manual data recording and storage systems

The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.

- Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements

- Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes relevant Good Manufacturing Practice (GMP) codes, the Therapeutic Goods Act, labelling, weights and measures legislation and legislation covering environmental management, occupational health and safety, anti-discrimination and equal opportunity

- Responsibility for applying good manufacturing practice relates to the person's work area

- Products/materials handled and stored can include raw materials, packaging components and consumables, part-processed product, finished product and cleaning materials

- Reporting systems may include electronic and manual data recording and storage systems

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
Relevant clothing and equipment appropriate towork requirements are available, functional and correctlyfitted 
Advice on GMP responsibilities and proceduresis accessible and clearly explained 
GMP control measures used in the work area canbe identified by those in the work area 
Mentoring and coaching support is available tosupport individuals/groups to implement GMP and relatedprocedures 
Training needs are identified and addressedwithin level of responsibility 
Personal hygiene of work team meets GMPrequirements 
Clothing is prepared, used, stored anddisposed of according to GMP and workplace procedures 
Personal movement around the workplacecomplies with area entry and exit procedures 
GMP procedures in the work area are clearlydefined, documented and followed 
Non-compliance with identified procedures isreported and addressed within level of responsibility 
Personal behaviour is consistent withworkplace policies and procedures that support GMP 
Workplace procedures to control resourceallocation and process are followed to meet GMP requirements 
GMP non-conformance is identified and reportedaccording to workplace procedure 
GMP information is recorded to meet workplacereporting requirements 
The workplace is maintained in a clean andtidy order to meet GMP housekeeping standards 
Validation practices and procedures arereviewed in consultation with relevant personnel 
Validation results and issues are identifiedand corrective action taken within level of responsibility 
Documentation and recording requirements meetGMP code and company requirements 
Processes, practices or conditions which couldresult in non-compliance with GMP are identified and reportedaccording to workplace reporting requirements 
Corrective action is taken in accordancewithin level of responsibility 
GMP issues are raised with designatedpersonnel 
Processes or conditions which could result innon-conformance with GMP are identified, reported and correctedwithin level of responsibility 
Matters raised relating to GMP are promptlyresolved and/or referred to appropriate personnel 
Effectiveness of control measures aremonitored within level of responsibility 
Others in the work area are advised of GMPmatters relevant to work role 
Changes to documentation are proposed inaccordance with workplace procedures to maintain GMP 
GMP audits are conducted to meet company andlegislative requirements 
Action is taken to respond to auditrecommendations within level of responsibility 

Forms

Assessment Cover Sheet

FDFPHGMP3A - Monitor the implementation of Good Manufacturing Practice procedures
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:


Assessment Record Sheet

FDFPHGMP3A - Monitor the implementation of Good Manufacturing Practice procedures

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: