Qualification Outline
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.
Certificate II in Pharmaceutical Manufacturing
Certificate II in Pharmaceutical Manufacturing
FBP20418
BEF4
Current
Approved
National Endorsed, State Implementation and Classification
Releases
| Release Version | Release Date | TGA Status | DTWD Status |
|---|---|---|---|
| 2.00 | 20/04/2022 | Current | Approved |
| 1.00 | 18/12/2018 | Replaced | Approved |
Description
This qualification describes the skills and knowledge for support roles within pharmaceutical manufacturing environments. Roles covered include equipment and facility cleaners, production machinery operators and packing line workers that work under routine supervision where the work is predictable and structured with limited judgement requirements.
Work must comply with good manufacturing practice, health and safety and environmental regulations and legislation that apply to the workplace.
No licensing, legislative or certification requirements apply to this qualification at the time of publication.
Schedule
Packaging Rules
To achieve this qualification, competency must be demonstrated in:- twelve (12) units of competency:
- five (5) core units, plus
- seven (7) elective units.
Elective units must ensure the integrity of the qualifications’ Australian Qualification Framework (AQF) alignment and contribute to a valid, industry-supported vocational outcome. The electives are to be chosen as follows:
- four (4) must be from electives Group A
- three (3) from the remaining units listed in groups A or B, or any currently endorsed Training Package or accredited course.
1. Core Units
All five (5) units must be completed.
| State Code | National Code | Title | Hours | Type |
|---|---|---|---|---|
| OAM67 | FBPPHM3004 | Clean and sanitise facilities and equipment | 25 | Unit of competency |
| OAL62 | FBPPHM2001 | Follow work procedures to maintain Good Manufacturing Practice requirements | 40 | Unit of competency |
| AWC13 | MSMENV272 | Participate in environmentally sustainable work practices | 20 | Unit of competency |
| OAN27 | FBPWHS2001 | Participate in work health and safety processes | 40 | Unit of competency |
| OAN33 | FBPOPR2071 | Provide and apply workplace information | 30 | Unit of competency |
2. Group A Elective Units
At least four (4) units must be completed.
Please refer to the packaging rules for the full details of available options.
| State Code | National Code | Title | Hours | Type |
|---|---|---|---|---|
| ODL43 | FBPOPR2074 | Carry out manual handling tasks | 30 | Unit of competency |
| ODL87 | FBPOPR2076 | Inspect and sort materials and product | 20 | Unit of competency |
| ODL84 | FBPOPR3008 | Load and unload tankers | 20 | Unit of competency |
| ODL10 | FBPBPG2012 | Operate a packaging process | 40 | Unit of competency |
| ODX75 | FBPPHM3021 | Operate a pharmaceutical production process | 45 | Unit of competency |
| OAM16 | FBPBPG3002 | Operate the labelling process | 60 | Unit of competency |
| OAN23 | FBPPHM3003 | Work in a controlled environment | 55 | Unit of competency |
| ODM31 | FBPOPR2078 | Work in a freezer storage area | 20 | Unit of competency |
| AVI99 | TLIG2007 | Work in a socially diverse environment | 20 | Unit of competency |
| ODM32 | FBPOPR2079 | Work with temperature controlled stock | 30 | Unit of competency |
3. Group B Elective Units
Up to three (3) units may be completed.
Please refer to the packaging rules for the full details of available options.
| State Code | National Code | Title | Hours | Type |
|---|---|---|---|---|
| OAO14 | FBPOPR2070 | Apply quality systems and procedures | 30 | Unit of competency |
| OCZ01 | TLIA0019 | Despatch stock | 20 | Unit of competency |
| OAE42 | TLILIC0003 | Licence to operate a forklift truck | 40 | Unit of competency |
| ODQ13 | TLID0015 | Load and unload goods/cargo | 30 | Unit of competency |
| ODP96 | TLID0016 | Operate a forklift | 35 | Unit of competency |
| OCY98 | TLIA0024 | Replenish stock | 20 | Unit of competency |
| ODP93 | TLID0021 | Store and handle dangerous goods and hazardous substances | 20 | Unit of competency |
| OCE05 | BSBTEC201 | Use business software applications | 55 | Unit of competency |
| AVI82 | TLIK2010 | Use infotechnology devices in the workplace | 40 | Unit of competency |
| OAM99 | FBPOPR2069 | Use numerical applications in the workplace | 20 | Unit of competency |
| AVL04 | TLIA2014 | Use product knowledge to complete work operations | 20 | Unit of competency |
| BAX88 | AMPX207 | Vacuum pack product | 80 | Unit of competency |
| OCD94 | BSBTWK201 | Work effectively with others | 35 | Unit of competency |
Replaces
| State Code | National Code | Title | Type |
|---|---|---|---|
| D679 | FDF20211 | Certificate II in Pharmaceutical Manufacturing | Qualification |
No information
Entry Requirements
There are no entry requirements for this qualification.