Unit of competency Outline
Date retreived
24/07/2026 12:20 AM AWST
24/07/2026 12:20 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.
Facilitate and monitor Good Manufacturing Practice
Facilitate and monitor Good Manufacturing Practice
Unit of competency
National Code
FDFPH4002A
FDFPH4002A
State Code
D4692
D4692
TGA Status
Deleted
Deleted
DTWD Status
Transition (Deleted)
Transition (Deleted)
State Implementation and Classification
Approved Date
04/08/2014
Field of Education
080317 - Quality Management
Original Release Date
04/08/2014
Nominal Hours
60
Description
This unit of competency targets content outlined in Chapter 4 of the Australian Code of Good Manufacturing Practice for Medicinal Products and should be read in conjunction with this document. It covers the skills and knowledge required to facilitate and monitor Good Manufacturing Practice (GMP) in a production/packaging work area.
Notes
Elements and Performance Criteria
1. Prepare to meet GMP requirements in the work area
- 1.1. Regulations, codes and guides relevant to the work area are identified
- 1.2. Workplace documentation relevant to work area activities is identified and reviewed to confirm that GMP requirements are met
- 1.3. The required facilities, materials, storage, equipment and personnel are confirmed and available
- 1.4. Operators who have the required competence to perform production/packaging activities to company and GMP standards are identified
- 1.5. Line clearance procedures are carried out
- 1.6. Critical processes are validated according to validation requirements
- 1.7. Procedures to eliminate or control the risk of cross-contamination are followed
2. Monitor the observance of GMP in the work area
- 2.1. Work practices conform to GMP requirements
- 2.2. In-process and environmental monitoring is carried out and recorded as required by GMP
- 2.3. Personal hygiene and conduct of personnel in the work area meets GMP requirements
- 2.4. Personnel movement between work areas complies with entry and exit procedures
- 2.5. GMP-related data is recorded to meet workplace reporting requirements
3. Respond to failures or non-conformances
- 3.1. The scope of failures or non-conformances are defined
- 3.2. Procedures to follow in the event of a failure are documented
- 3.3. Failures are investigated to determine root causes
- 3.4. Risk assessment is conducted
- 3.5. Findings are reported to meet GMP requirements
- 3.6. Procedures are followed to implement and monitor corrective and preventative action
4. Complete work to meet GMP requirements
- 4.1. Processes are reviewed to ensure all procedures are complete
- 4.2. Line logs are reviewed to ensure documentation is complete
- 4.3. End-of-batch procedures are followed
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.
Regulations, codes and guides
Relevant regulations, codes and guides include:
Therapeutic Goods Act
Therapeutic Goods Regulations
Australian Code of Good Manufacturing Practice for Medicinal Products
Therapeutic Goods Act guides to interpretation of legal requirements
regulations, codes and guides related to other relevant international legislation (appropriate to product and market)
company policies and guidelines
Workplace documentation
Workplace documentation relevant to work area activities includes:
company policies and guidelines
specifications
manufacturing formulae
processing and packaging instructions
batch production and packaging records
standard operating procedures (SOPs)
occupational health and safety (OHS) information, including material safety data sheets (MSDS)
Work practices
Work is carried out according to:
company policies and procedures
legislative and licensing requirements, including therapeutic goods legislation, weights and measures and legislation relating to OHS, environmental management, equal opportunity and affirmative action, industrial awards and agreements
Sources of technical advice
Sources of technical advice include but are not limited to:
Therapeutic Goods Administration
British Pharmacopeia
European Pharmacopeia
US Pharmacopeia
Systems, programs and procedures to support GMP
Systems, programs and procedures to support GMP includes but is not limited to:
line clearance
cleaning and sanitation
process control
control of cross-contamination
failure investigation
change control
validation
record keeping and documentation management
release for sale
internal audits
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.
Regulations, codes and guides
Relevant regulations, codes and guides include:
Therapeutic Goods Act
Therapeutic Goods Regulations
Australian Code of Good Manufacturing Practice for Medicinal Products
Therapeutic Goods Act guides to interpretation of legal requirements
regulations, codes and guides related to other relevant international legislation (appropriate to product and market)
company policies and guidelines
Workplace documentation
Workplace documentation relevant to work area activities includes:
company policies and guidelines
specifications
manufacturing formulae
processing and packaging instructions
batch production and packaging records
standard operating procedures (SOPs)
occupational health and safety (OHS) information, including material safety data sheets (MSDS)
Work practices
Work is carried out according to:
company policies and procedures
legislative and licensing requirements, including therapeutic goods legislation, weights and measures and legislation relating to OHS, environmental management, equal opportunity and affirmative action, industrial awards and agreements
Sources of technical advice
Sources of technical advice include but are not limited to:
Therapeutic Goods Administration
British Pharmacopeia
European Pharmacopeia
US Pharmacopeia
Systems, programs and procedures to support GMP
Systems, programs and procedures to support GMP includes but is not limited to:
line clearance
cleaning and sanitation
process control
control of cross-contamination
failure investigation
change control
validation
record keeping and documentation management
release for sale
internal audits
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 pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and document management systems related to GMP that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial production/packaging equipment and activities typically used in a commercial manufacturing environment.
Critical aspects for assessment and evidence required to demonstrate competency in this unit
Evidence of participation in a project team to develop or review systems and procedures to support GMP in a work area. This includes providing evidence that the candidate:
provides documented evidence through use of workplace documentation and records to show that the work preparation, processing and completion meet GMP requirements
leads response to a failure or non-conformance in the work area. This must include conducting risk assessment, analysing root cause analysis, identifying corrective and preventive action and monitoring implementation. This aspect of assessment may be undertaken as part of a team.
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 responding to 'what if' scenarios, answering questions and conducting workplace projects.
Method of assessment
This unit is a core requirement for all pharmaceutical operators at AQF 4 and 5. It could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:
FDFOP2015A Apply principles of statistical process control
FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice
FDFPH4003A Facilitate contamination control
FDFPH4004A Participate in change control procedures
FDFPH4005A Participate in validation processes
MSACMT450A Undertake process capability improvements.
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 pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and document management systems related to GMP that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial production/packaging equipment and activities typically used in a commercial manufacturing environment.
Critical aspects for assessment and evidence required to demonstrate competency in this unit
Evidence of participation in a project team to develop or review systems and procedures to support GMP in a work area. This includes providing evidence that the candidate:
provides documented evidence through use of workplace documentation and records to show that the work preparation, processing and completion meet GMP requirements
leads response to a failure or non-conformance in the work area. This must include conducting risk assessment, analysing root cause analysis, identifying corrective and preventive action and monitoring implementation. This aspect of assessment may be undertaken as part of a team.
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 responding to 'what if' scenarios, answering questions and conducting workplace projects.
Method of assessment
This unit is a core requirement for all pharmaceutical operators at AQF 4 and 5. It could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:
FDFOP2015A Apply principles of statistical process control
FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice
FDFPH4003A Facilitate contamination control
FDFPH4004A Participate in change control procedures
FDFPH4005A Participate in validation processes
MSACMT450A Undertake process capability improvements.
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 |
|---|---|---|---|
| W7078 | FDFPHGMP4A | Facilitate and monitor Good Manufacturing Practice | Unit of competency |
| State Code | National Code | Title | Type |
|---|---|---|---|
| S776 | FDF50210 | Diploma of Pharmaceutical Manufacturing | Qualification |
| S774 | FDF40210 | Certificate IV in Pharmaceutical Manufacturing | Qualification |