Qualification Outline

Date retreived
22/07/2026 7:33 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

Qualification
National Code:
FDF20211
State Code:
D679
TGA Status:
Replaced
DTWD Status:
Replaced
National Endorsed, State Implementation and Classification
Field of Education
0303 - Process And Resources Engineering
Original TGA Release Date
06/09/2012
Approved Date
31/07/2014
Stream of Study
Initial Vocational (3100 - 3600)
VET Act Classifier
C
Nominal Hours
559
Duration
2 Semesters
Current Release Number
3.00
Current Release Date
06/09/2012
VET Act Conditions
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 II in Pharmaceutical Manufacturing targets those working within production or production support roles, such as packing within pharmaceutical manufacturing environments. This Qualification is designed for application in supervised environments where the work is predictable with some basic problem solving requirements.

Additional Qualification advice
Units selected from other Training Packages must be relevant to the work outcome, local industry requirements and the Qualification level.

Many Units in this Qualification assume a basic level of mathematics equivalent to a school sector Year 10 standard. If a student does not possess this level of mathematics then the Unit FDFOP2061A Use numerical applications in the workplace should be selected as part of this Qualification.

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 twelve (12) units of competency in accordance with the following rules.

Total units must include a minimum of seven (7) units coded FDF.
Four (4) Core units
Eight (8) Elective units

Elective selection must include:
- five (5) Group A elective units

Three (3) remaining elective units may be selected from:
- Group A elective units below, not previously selected
- Group B elective units
- units from this Training Package, any other nationally endorsed Training Package and accredited course that are packaged at Certificate I level (maximum 1 unit), Certificate II (maximum 2 units),and Certificate III level (maximum 1 unit)
1. Core Units

All four (4) units must be completed

State Code National Code Title Hours Type
D4676 FDFPH2001A Apply Good Manufacturing Practice procedures 54 Unit of competency
D3655 MSAENV272B Participate in environmentally sustainable work practices 20 Unit of competency
D4574 FDFOHS2001A Participate in OHS processes 40 Unit of competency
D4652 FDFOP2064A Provide and apply workplace information 30 Unit of competency
2. Elective Units

A minimum of five (5) of the eight (8) units required 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
D4603 FDFOP2015A Apply principles of statistical process control 30 Unit of competency
D4601 FDFOP2013A Apply sampling procedures 20 Unit of competency
D4581 FDFOP1003A Carry out manual handling tasks 30 Unit of competency
D4592 FDFOP2004A Clean and sanitise equipment 20 Unit of competency
D4591 FDFOP2003A Clean equipment in place 30 Unit of competency
D4885 TLIA2009A Complete and check import/export documentation 40 Unit of competency
D4599 FDFOP2011A Conduct routine maintenance 50 Unit of competency
D4682 FDFPH2007A Coordinate a label store 55 Unit of competency
D4891 TLIA2021A Despatch stock 20 Unit of competency
D4615 FDFOP2027A Dispense non-bulk ingredients 20 Unit of competency
D4684 FDFPH2009A Dispense pharmaceutical raw materials 60 Unit of competency
D4607 FDFOP2019A Fill and close product in cans 50 Unit of competency
D4643 FDFOP2055A Freeze dough 10 Unit of competency
D5063 TLID2003A Handle dangerous goods/hazardous substances 20 Unit of competency
D4590 FDFOP2002A Inspect and sort materials and product 20 Unit of competency
D5064 TLID2004A Load and unload goods/cargo 30 Unit of competency
D4597 FDFOP2009A Load and unload tankers 20 Unit of competency
D4600 FDFOP2012A Maintain food safety when loading, unloading and transporting food 35 Unit of competency
D4613 FDFOP2025A Manufacture extruded and toasted products 40 Unit of competency
D4617 FDFOP2029A Operate a baking process 55 Unit of competency
D4605 FDFOP2017A Operate a blending, sieving and bagging process 45 Unit of competency
D4594 FDFOP2006A Operate a bulk dry goods transfer process 30 Unit of competency
D4596 FDFOP2008A Operate a bulk liquid transfer process 30 Unit of competency
D4606 FDFOP2018A Operate a case packing process 45 Unit of competency
D4640 FDFOP2052A Operate a chocolate tempering process 20 Unit of competency
D4619 FDFOP2031A Operate a coating application process 35 Unit of competency
D4683 FDFPH2008A Operate a compressing process 60 Unit of competency
D4677 FDFPH2002A Operate a concentration process 40 Unit of competency
D4647 FDFOP2059A Operate a continuous freezing process 50 Unit of competency
D4612 FDFOP2024A Operate a cooling, slicing and wrapping process 50 Unit of competency
D4621 FDFOP2033A Operate a depositing process 60 Unit of competency
D4630 FDFOP2042A Operate a drying process 60 Unit of competency
D4609 FDFOP2021A Operate a fill and seal process 55 Unit of competency
D4625 FDFOP2037A Operate a filtration process 55 Unit of competency
D5066 TLID2010A Operate a forklift 40 Unit of competency
D4608 FDFOP2020A Operate a form, fill and seal process 55 Unit of competency
D4614 FDFOP2026A Operate a forming or shaping process 50 Unit of competency
D4644 FDFOP2056A Operate a freezing process 60 Unit of competency
D4627 FDFOP2039A Operate a frying process 55 Unit of competency
D4686 FDFPH2011A Operate a granulation process 60 Unit of competency
D4626 FDFOP2038A Operate a grinding process 20 Unit of competency
D4628 FDFOP2040A Operate a heat treatment process 60 Unit of competency
D4610 FDFOP2022A Operate a high speed wrapping process 45 Unit of competency
D4646 FDFOP2058A Operate a holding and storage process 15 Unit of competency
D4687 FDFPH2012A Operate a liquid manufacturing process 70 Unit of competency
D4645 FDFOP2057A Operate a membrane process 60 Unit of competency
D4629 FDFOP2041A Operate a mixing or blending and cooking process 55 Unit of competency
D4616 FDFOP2028A Operate a mixing or blending process 40 Unit of competency
D4611 FDFOP2023A Operate a packaging process 40 Unit of competency
D4635 FDFOP2047A Operate a portion saw 35 Unit of competency
D4618 FDFOP2030A Operate a process control interface 35 Unit of competency
D4634 FDFOP2046A Operate a production process 50 Unit of competency
D4637 FDFOP2049A Operate a reduction process 20 Unit of competency
D4632 FDFOP2044A Operate a retort process 50 Unit of competency
D4638 FDFOP2050A Operate a separation process 50 Unit of competency
D4679 FDFPH2004A Operate a separation process using chromatography 60 Unit of competency
D4639 FDFOP2051A Operate a spreads production process 50 Unit of competency
D4688 FDFPH2013A Operate a tablet coating process 60 Unit of competency
D4689 FDFPH2014A Operate a terminal sterilisation process 60 Unit of competency
D4641 FDFOP2053A Operate a washing and drying process 30 Unit of competency
WD852 FDFSUG222A Operate a waste water treatment system 40 Unit of competency
D4642 FDFOP2054A Operate a water purification process 40 Unit of competency
D4680 FDFPH2005A Operate an aseptic fill and seal process 55 Unit of competency
D4681 FDFPH2006A Operate an aseptic form, fill and seal process 60 Unit of competency
D4648 FDFOP2060A Operate an automated cutting process 35 Unit of competency
D4685 FDFPH2010A Operate an encapsulation process 60 Unit of competency
D4623 FDFOP2035A Operate an enrobing process 30 Unit of competency
D4622 FDFOP2034A Operate an evaporation process 60 Unit of competency
D4678 FDFPH2003A Operate an extraction process 40 Unit of competency
D4624 FDFOP2036A Operate an extrusion process 55 Unit of competency
D4631 FDFOP2043A Operate an homogenising process 20 Unit of competency
W7561 PMBPROD211B Operate blow moulding equipment 60 Unit of competency
W7596 PMBPROD270B Operate injection blow moulding equipment 70 Unit of competency
D4633 FDFOP2045A Operate pumping equipment 30 Unit of competency
D4602 FDFOP2014A Participate in sensory analyses 35 Unit of competency
D4659 FDFPPL2001A Participate in work teams and groups 20 Unit of competency
WA705 MSL973001A Perform basic tests 80 Unit of competency
D4636 FDFOP2048A Pre-process raw materials 40 Unit of competency
D4922 TLIA4025A Regulate temperature controlled stock 20 Unit of competency
D9017 MTMPSR203A Sharpen knives 40 Unit of competency
D5190 TLIK2010A Use infotechnology devices in the workplace 40 Unit of competency
D4649 FDFOP2061A Use numerical applications in the workplace 20 Unit of competency
D4889 TLIA2014A Use product knowledge to complete work operations 20 Unit of competency
D9015 MTMPSR201C Vacuum pack product 80 Unit of competency
D4589 FDFOP2001A Work effectively in the food processing industry 30 Unit of competency
D4620 FDFOP2032A Work in a clean room environment 35 Unit of competency
D4604 FDFOP2016A Work in a food handling area for non-food handlers 30 Unit of competency
D4595 FDFOP2007A Work in a freezer storage area 20 Unit of competency
D4598 FDFOP2010A Work with temperature controlled stock 30 Unit of competency
3. Group B Elective Units

The remaining units may 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
S6192 SIRXSLS002A Advise on products and services 25 Unit of competency
WD503 MSS402040A Apply 5S procedures 30 Unit of competency
WD496 MSS402001A Apply competitive systems and practices 40 Unit of competency
WD501 MSS402030A Apply cost factors to work practices 35 Unit of competency
WD500 MSS402021A Apply Just in Time procedures 30 Unit of competency
WD506 MSS402051A Apply quality standards 30 Unit of competency
WD960 SIRXFIN201 Balance and secure point-of-sale terminal 20 Unit of competency
D0782 BSBITU202A Create and use spreadsheets 20 Unit of competency
WD502 MSS402031A Interpret product costs in terms of customer requirements 30 Unit of competency
WD498 MSS402010A Manage the impact of change on own work 40 Unit of competency
WD969 SIRXMER201 Merchandise products 35 Unit of competency
S6187 SIRXRSK001A Minimise theft 20 Unit of competency
WD505 MSS402050A Monitor process capability 30 Unit of competency
WD848 FDFSUG218A Operate a boiler - basic 60 Unit of competency
S6126 SIRXFIN002A Perform retail finance duties 25 Unit of competency
D0781 BSBITU201A Produce simple word processed documents 40 Unit of competency
D8246 HLTFA201B Provide basic emergency life support 10 Unit of competency
WD497 MSS402002A Sustain process improvements 40 Unit of competency
WD511 MSS402080A Undertake root cause analysis 30 Unit of competency
D1027 BSBWOR204A Use business technology 30 Unit of competency
WD509 MSS402060A Use planning software systems in operations 30 Unit of competency
WD510 MSS402061A Use SCADA systems in operations 30 Unit of competency
D4593 FDFOP2005A Work in a socially diverse environment 30 Unit of competency
Replaces
State Code National Code Title Type
S763 FDF20210 Certificate II in Pharmaceutical Manufacturing Qualification
Replaced By
State Code National Code Title Type
BEF4 FBP20418 Certificate II in Pharmaceutical Manufacturing Qualification
No information
Entry Requirements

Not applicable.

Traineeships and Apprenticeships
No information