Qualification Outline
22/07/2026 4:13 AM AWST
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Certificate IV in Pharmaceutical Manufacturing
Certificate IV in Pharmaceutical Manufacturing
FDF40210
S774
Replaced
Replaced
National Endorsed, State Implementation and Classification
Releases
| Release Version | Release Date | TGA Status | DTWD Status |
|---|---|---|---|
| 3.00 | 06/09/2012 | Current | Approved |
Description
This Qualification covers the Pharmaceutical Manufacturing specialisation.
Job Roles
The Certificate IV in Pharmaceutical Manufacturing targets those working in supervisory, middle management or those requiring technical roles within pharmaceutical manufacturing environments. Emphasis is on monitoring of pharmaceutical manufacturing systems and procedures with input into management functions of the organisation.
Additional Qualification advice
Units selected from other Training Packages must be relevant to the work outcome, local industry requirements and the Qualification level.
Note: AgriFood Skills Australia expects that the design of any training delivery and assessment program to support the achievement of this Qualification is based on:
the context required by the industry and/or enterprise
a holistic and integrated training delivery and assessment plan that identifies learning activities and evidence required
flexible delivery options including on-the-job and work-based training that support the development of competency.
Schedule
Packaging Rules
This qualification requires the achievement of twenty one (21) units of competency in accordance with the following rules.Total units must include a minimum of eleven (11) units coded FDF.
- seven (7) core units
- fourteen (14) elective units
- a minimum of one (1) Group A elective unit
- a minimum of one (1) Group B elective unit
- a minimum of five (5) Specialist Technical Group C elective units
- seven (7) remaining elective units may be selected from:
- Group A elective units below, not previously selected
- Group B elective units below, not previously selected
- Group C elective units below, not previously selected
- Group D elective units
- Units packaged at FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 3)
- Units packaged at FDF30210 Certificate III in Pharmaceutical Manufacturing (maximum of 5)
- Units packaged at FDF50210 Diploma of Pharmaceutical Manufacturing (maximum of 2)
- a maximum of four (4) units from any nationally endorsed Training Package and accredited course that are packaged at Certificate II level (maximum 2 units), Certificate III level (maximum 2 units), Certificate IV level (maximum 4 units), and Diploma level (maximum 2 units)
1. Core Units
Seven (7) units must be completed.
| State Code | National Code | Title | Hours | Type |
|---|---|---|---|---|
| D4692 | FDFPH4002A | Facilitate and monitor Good Manufacturing Practice | 60 | Unit of competency |
| D4693 | FDFPH4003A | Facilitate contamination control | 40 | Unit of competency |
| D3656 | MSAENV472B | Implement and monitor environmentally sustainable work practices | 40 | Unit of competency |
| D4695 | FDFPH4005A | Participate in validation processes | 40 | Unit of competency |
| D4691 | FDFPH4001A | Prepare and review workplace documentation to support Good Manufacturing Practice | 60 | Unit of competency |
| D4661 | FDFPPL3002A | Report on workplace performance | 35 | Unit of competency |
| D4696 | FDFPH4006A | Respond to non-conformance | 60 | Unit of competency |
2. Group A Elective Units
A minimum of one (1) unit must be chosen from Group A.
Please refer to the packaging rules for the full details of available options.
| State Code | National Code | Title | Hours | Type |
|---|---|---|---|---|
| D4576 | FDFOHS4001A | Identify, assess and control OHS risk in own work | 50 | Unit of competency |
| D4577 | FDFOHS4002A | Maintain OHS processes | 60 | Unit of competency |
3. Group B Elective Units
A minimum of one (1) unit must be chosen from Group B.
Please refer to the packaging rules for the full details of available options.
| State Code | National Code | Title | Hours | Type |
|---|---|---|---|---|
| D4656 | FDFOP3004A | Operate interrelated processes in a packaging system | 60 | Unit of competency |
| D4655 | FDFOP3003A | Operate interrelated processes in a production system | 60 | Unit of competency |
4. Group C Elective Units
A minimum of five (5) units must be chosen from Group C.
Please refer to the packaging rules for the full details of available options.
5. Group D Elective Units
The remaining units may be chosen from Group D.
Please refer to the packaging rules for the full details of available options.
Replaces
| State Code | National Code | Title | Type |
|---|---|---|---|
| AXG1 | FDF40207 | Certificate IV in Pharmaceutical Manufacturing | Qualification |
Replaced By
| State Code | National Code | Title | Type |
|---|---|---|---|
| BEE8 | FBP40518 | Certificate IV in Pharmaceutical Manufacturing | Qualification |
No information
Entry Requirements
Not applicable.
Traineeships and Apprenticeships