Unit of competency Outline
Date retreived
22/07/2026 6:45 AM AWST
22/07/2026 6:45 AM AWST
Whilst all efforts are made to provide accurate and timely information from the relevant source/documentation, please be aware that the information supplied may not be the most current version. The accuracy of the detail has not been confirmed by the Department and therefore should not be relied upon without first confirming the contents.
Monitor and maintain Good Manufacturing Practice procedures
Monitor and maintain Good Manufacturing Practice procedures
Unit of competency
National Code
FDFPH3001A
FDFPH3001A
State Code
D4690
D4690
TGA Status
Replaced
Replaced
DTWD Status
Replaced
Replaced
State Implementation and Classification
Approved Date
17/06/2011
Field of Education
080317 - Quality Management
Original Release Date
17/06/2011
Nominal Hours
80
Description
This unit of competency 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.
Notes
Elements and Performance Criteria
1. Ensure others in the work area are able to meet GMP requirements
- 1.1. Relevant clothing and equipment appropriate to work requirements is available, functional and correctly fitted
- 1.2. Advice on GMP responsibilities and procedures is accessible and clearly explained
- 1.3. GMP control measures used in the work area can be identified by those in the work area
- 1.4. Mentoring and coaching support is available to support individuals/groups to implement GMP and related procedures
- 1.5. Training needs are identified and addressed within level of responsibility
2. Monitor personal hygiene and conduct of team members in the work area
- 2.1. Personal hygiene of work team meets GMP requirements
- 2.2. Clothing is prepared, used, stored and disposed of according to GMP and workplace procedures
- 2.3. Personal movement around the workplace complies with area entry and exit procedures
3. Monitor implementation of GMP requirements in the work area
- 3.1. GMP procedures in the work area are clearly defined, documented and followed
- 3.2. Non-compliance from identified procedures is reported and addressed within level of responsibility
- 3.3. Signs of unacceptable plant or equipment condition are identified and reported
- 3.4. Personal behaviour provides a role model to others to support implementation of GMP workplace policies and procedures
- 3.5. Workplace procedures to control resource allocation are followed to meet GMP requirements
- 3.6. GMP non-conformance is identified and reported according to workplace procedure
- 3.7. GMP information is recorded to meet workplace reporting requirements
- 3.8. The workplace is maintained in a clean and tidy order to meet GMP housekeeping standards
4. Participate in validation processes
- 4.1. Validation procedures are followed to GMP requirements
- 4.2. Issues arising from validation are raised with designated personnel
- 4.3. Validation procedures are documented to meet GMP requirements
5. Take corrective action in response to GMP non-compliance
- 5.1. Processes, practices or conditions which could result in non-compliance with GMP are identified and reported according to workplace reporting requirements
- 5.2. Corrective action is taken in accordance within level of responsibility
- 5.3. GMP issues are raised with designated personnel
6. Maintain and improve GMP in the work area
- 6.1. Processes or conditions which could result in non-conformance with GMP are identified, reported and corrected within level of responsibility
- 6.2. Matters raised relating to GMP are promptly resolved and/or referred to appropriate personnel
- 6.3. Effectiveness of control measures are monitored within level of responsibility
- 6.4. Others in the work area are advised of GMP matters relevant to work role
- 6.5. Workplace records and documents are maintained in accordance with workplace procedures and GMP requirements
RANGE STATEMENT
The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.
Work activities
Work activities are carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements
Unacceptable plant or equipment condition
Unacceptable plant or equipment condition can include:
damage to plant or equipment
failure of cleaning regime
equipment requiring calibration
signs of pest infestation
Validation
Typically validation is the responsibility of the quality department. A person at this level would be expected to understand the purpose and responsibilities for validation and may be required to participate in validation processes as part of a team
Legislative requirements
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 and other legislation and codes relevant to product and market
legislation relating to environmental management, occupational health and safety (OHS), anti-discrimination and equal opportunity
Quality assurance and related system components and activities
Quality assurance and related system components and activities can include but is not limited to:
process control
deviation investigation and analysis
corrective and preventative action systems
sampling plans
change control
validation procedures
line clearance
system documentation requirements
audit processes
The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.
Work activities
Work activities are carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements
Unacceptable plant or equipment condition
Unacceptable plant or equipment condition can include:
damage to plant or equipment
failure of cleaning regime
equipment requiring calibration
signs of pest infestation
Validation
Typically validation is the responsibility of the quality department. A person at this level would be expected to understand the purpose and responsibilities for validation and may be required to participate in validation processes as part of a team
Legislative requirements
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 and other legislation and codes relevant to product and market
legislation relating to environmental management, occupational health and safety (OHS), anti-discrimination and equal opportunity
Quality assurance and related system components and activities
Quality assurance and related system components and activities can include but is not limited to:
process control
deviation investigation and analysis
corrective and preventative action systems
sampling plans
change control
validation procedures
line clearance
system documentation requirements
audit processes
EVIDENCE GUIDE
The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.
Overview of assessment
Assessment may occur in a real or simulated workplace context. A simulated environment must provide access to a typical range of production equipment, procedures and related documentation, records and related resources to meet the requirements of the Therapeutic Goods Act.
Critical aspects for assessment and evidence required to demonstrate competency in this unit
GMP is an ongoing and routine aspect of work responsibilities. Assessors should collect sufficient evidence that the skills and knowledge of this unit are routinely applied to the work environment.
Evidence of ability to:
identify the components of GMP and related roles and responsibilities as they relate to work role
provide a role model to others in the workplace to support implementation of GMP
participate in GMP processes within level of responsibility. Examples of these processes include validation, line clearance, equipment calibration, change management, maintenance of documentation. This would typically be undertaken in a team context.
Context of and specific resources for assessment
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.
Assessment of this unit would typically involve questioning and workplace observation. It may involve additional collection of evidence from a range of sources, such as third party reports, workplace documentation relating to GMP, and real or simulated workplace contexts.
Method of assessment
This unit is a core requirement for all pharmaceutical operators at AQF 3 and could be assessed concurrently with other units relating to process improvement and supporting others, such as:
FDFPPL3001A Participate in improvement processes
FDFPPL3003A Support and mentor individuals and groups
FDFPPL3005A Participate in an audit process
FDFTEC3001A Participate in a HACCP team.
Guidance information for assessment
To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.
The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.
Overview of assessment
Assessment may occur in a real or simulated workplace context. A simulated environment must provide access to a typical range of production equipment, procedures and related documentation, records and related resources to meet the requirements of the Therapeutic Goods Act.
Critical aspects for assessment and evidence required to demonstrate competency in this unit
GMP is an ongoing and routine aspect of work responsibilities. Assessors should collect sufficient evidence that the skills and knowledge of this unit are routinely applied to the work environment.
Evidence of ability to:
identify the components of GMP and related roles and responsibilities as they relate to work role
provide a role model to others in the workplace to support implementation of GMP
participate in GMP processes within level of responsibility. Examples of these processes include validation, line clearance, equipment calibration, change management, maintenance of documentation. This would typically be undertaken in a team context.
Context of and specific resources for assessment
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.
Assessment of this unit would typically involve questioning and workplace observation. It may involve additional collection of evidence from a range of sources, such as third party reports, workplace documentation relating to GMP, and real or simulated workplace contexts.
Method of assessment
This unit is a core requirement for all pharmaceutical operators at AQF 3 and could be assessed concurrently with other units relating to process improvement and supporting others, such as:
FDFPPL3001A Participate in improvement processes
FDFPPL3003A Support and mentor individuals and groups
FDFPPL3005A Participate in an audit process
FDFTEC3001A Participate in a HACCP team.
Guidance information for assessment
To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.
Replaces
| State Code | National Code | Title | Type |
|---|---|---|---|
| W7080 | FDFPHGMP3A | Monitor the implementation of Good Manufacturing Practice procedures | Unit of competency |
Replaced By
| State Code | National Code | Title | Type |
|---|---|---|---|
| OAM08 | FBPPHM4001 | Monitor and maintain Good Manufacturing Practice requirements | Unit of competency |
| State Code | National Code | Title | Type |
|---|---|---|---|
| S767 | FDF30210 | Certificate III in Pharmaceutical Manufacturing | Qualification |