Modification History
|
Release |
Comments |
|
Release 1 |
This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 5.0. |
Qualification Description
This qualification describes the skills and knowledge for production and packaging roles carried out under broad supervision within pharmaceutical manufacturing environments. Individuals with this qualification perform tasks involving a broad range of skills that are applied in a wide variety of contexts, which will involve discretion and judgement in selecting and operating equipment, coordinating resources and applying contingency measures during work.
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.
Entry Requirements
There are no entry requirements for this qualification.
Packaging Rules
To achieve this qualification, competency must be demonstrated in:
- 16 units of competency:
- 5 core units, plus
- 11 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:
- 5 must be from group A
- 4 must be from group B
- 2 from the remaining units listed in groups A or B, or any currently endorsed Training Package or accredited course.
Core Units
|
BSBWHS311 |
Assist with maintaining workplace safety |
|
FBPPHM3001 |
Apply Good Manufacturing Practice requirements |
|
FBPPHM3002 |
Operate a pharmaceutical production process |
|
FBPPHM3003 |
Work in a controlled environment |
|
FBPPHM3004 |
Clean and sanitise facilities and equipment |
Elective Units
Group A
|
FBPOPR2028 |
Operate a mixing or blending process |
|
FBPOPR3005 |
Operate interrelated processes in a production system |
|
FBPOPR3006 |
Operate interrelated processes in a packaging system |
|
FBPPHM3005 |
Operate a concentration process |
|
FBPPHM3006 |
Operate an extraction process |
|
FBPPHM3008 |
Operate an aseptic fill and seal process |
|
FBPPHM3009 |
Operate an aseptic form, fill and seal process |
|
FBPPHM3010 |
Operate a compressing process |
|
FBPPHM3011 |
Dispense pharmaceutical raw materials |
|
FBPPHM3012 |
Operate an encapsulation process |
|
FBPPHM3013 |
Operate a granulation process |
|
FBPPHM3014 |
Operate a liquid manufacturing process |
|
FBPPHM3015 |
Operate a tablet coating process |
|
FBPPHM3017 |
Coordinate a label store |
|
FBPPHM3018 |
Operate a sterilisation process using an autoclave |
|
FBPPHM3019 |
Operate a chromatography manufacturing process |
|
MSL922001 |
Record and present data |
|
MSS402061 |
Use SCADA systems in operations |
Group B
|
BSBWRT311 |
Write simple documents |
|
FBPOPR2070 |
Apply quality systems and procedures |
|
FBPOPR3004 |
Set up a production or packaging line for operation |
|
FBPPPL3003 |
Participate in improvement processes |
|
FBPPPL3005 |
Participate in an audit process |
|
FBPPPL3006 |
Report on workplace performance |
|
FBPTEC3001 |
Apply raw materials, ingredient and process knowledge to production problems |
|
FBPWHS2001 |
Participate in work health and safety processes |
|
HLTAID011 |
Provide First Aid |
|
MSL973013 |
Perform basic tests |
|
MSMENV272 |
Participate in environmentally sustainable work practices |
|
MSMPMC400 |
Carry out stock control |
|
MSMSUP303 |
Identify equipment faults |
|
MSMSUP310 |
Contribute to the development of workplace documentation |
|
MSMSUP390 |
Use structured problem-solving tools |
|
MSS402021 |
Apply Just in Time procedures |
|
MSS403085 |
Ensure process improvements are sustained |
|
SIRCDIS006 |
Maintain dispensary stock |
|
TLIA0003 |
Complete and check import/export documentation |
|
TLIA0004 |
Complete receival and despatch documentation |
|
TLIA0015 |
Organise receival and despatch operations |
|
TLIA4025 |
Regulate temperature controlled stock |
|
TLIX0004X |
Administer inventory systems |
|
TLIX0013X |
Maintain stock control and receivals |
Qualification Mapping Information
|
Code and title current version |
Code and title previous version |
Comments |
Equivalence status |
|
FBP30821 Certificate III in Pharmaceutical Manufacturing |
FBP30818 Certificate III in Pharmaceutical Manufacturing |
Updated unit codes in core and elective bank of Packaging Rules |
Equivalent |
Links
Companion Volumes, including Implementation Guides, are available at VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4
