Qualification Outline

Date retreived
22/07/2026 6:29 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.

Diploma of Pharmaceutical Manufacturing

Diploma of Pharmaceutical Manufacturing

Qualification
National Code:
FDF50210
State Code:
S776
TGA Status:
Deleted
DTWD Status:
Transition (Deleted)
National Endorsed, State Implementation and Classification
Field of Education
0303 - Process And Resources Engineering
Original TGA Release Date
06/09/2012
Approved Date
04/08/2014
Stream of Study
Initial Vocational (3100 - 3600)
VET Act Classifier
C
Nominal Hours
1435
Duration
4 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 Diploma of Pharmaceutical Manufacturing targets those in senior management, technician or similar roles within pharmaceutical manufacturing industries. It provides extensive skills and knowledge of industry management functions and environment, and the ability to take responsibility for workplace systems.

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 nine (29) units of competency in accordance with the following rules.
Total units must include a minimum of eleven (11) units coded FDF.
- nine (9) core units
- twenty (20) elective units
- one (1) Group A elective unit
- one (1) Group B elective unit
- six (6) Group C elective units
- five (5) Specialist and Cross Sector units packaged at Certificate IV Group C
- 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 FDF30210 Certificate III in Pharmaceutical Manufacturing or FDF40210 Certificate IV in Pharmaceutical Manufacturing (maximum of 5)
- units packaged at FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 5)
- 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 3 units), Diploma or Advanced Diploma level (maximum 3 units)
1. Core Units

Nine (9) units must be completed.

State Code National Code Title Hours Type
D4744 FDFTEC4007A Describe and analyse data using mathematical principles 45 Unit of competency
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
D4666 FDFPPL4001A Manage people in the work area 45 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
D4578 FDFOHS5001A Manage 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 six (6) units must be chosen from Group C.
Please refer to the packaging rules for the full details of available options.

State Code National Code Title Hours Type
D4674 FDFPPL5001A Design and maintain programs to support legal compliance 50 Unit of competency
WD568 MSS405050A Determine and improve process capability 60 Unit of competency
WD574 MSS405070A Develop and manage sustainable energy practices 60 Unit of competency
W9029 MSACMT671A Develop and manage sustainable environmental practices 60 Unit of competency
WD545 MSS405001A Develop competitive systems and practices for an organisation 60 Unit of competency
D0640 BSBCOM503B Develop processes for the management of breaches in compliance requirements 30 Unit of competency
WD557 MSS405020A Develop quick changeover procedures 60 Unit of competency
D0596 BSBATSIM507B Establish and maintain a strategic planning cycle 50 Unit of competency
D0639 BSBCOM502B Evaluate and review compliance 25 Unit of competency
D4868 BSBMGT516C Facilitate continuous improvement 50 Unit of competency
D4749 FDFTEC5001A Manage and evaluate new product trials 60 Unit of competency
D0847 BSBMGT515A Manage operational plan 50 Unit of competency
D0846 BSBMGT502B Manage people performance 50 Unit of competency
WD553 MSS405011A Manage people relationships 60 Unit of competency
D0938 BSBPMG510A Manage projects 45 Unit of competency
D4672 FDFPPL4007A Manage supplier agreements and contracts 50 Unit of competency
D4750 FDFTEC5002A Manage utilities and energy for a production process 50 Unit of competency
W5450 MEM15001B Perform basic statistical quality control 18 Unit of competency
D4668 FDFPPL4003A Schedule and manage production 45 Unit of competency
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.

State Code National Code Title Hours Type
WD578 MSS405083A Adapt a proactive maintenance strategy for a seasonal or cyclical business 60 Unit of competency
WD577 MSS405082A Adapt a proactive maintenance strategy to the process operations sector 60 Unit of competency
WD546 MSS405002A Analyse and map a value stream 60 Unit of competency
WD564 MSS405032A Analyse cost implications of maintenance strategy 60 Unit of competency
WD501 MSS402030A Apply cost factors to work practices 35 Unit of competency
WD538 MSS404052A Apply statistics to operational processes 40 Unit of competency
D0905 BSBOHS503B Assist in the design and development of OHS participative arrangements 50 Unit of competency
WD559 MSS405022A Design a process layout 80 Unit of competency
WD572 MSS405061A Determine and establish information collection requirements and processes 60 Unit of competency
WD550 MSS405006A Develop a Balanced Scorecard 40 Unit of competency
WD556 MSS405014A Develop a communications strategy to support operations 50 Unit of competency
WD573 MSS405062A Develop a documentation control strategy for an organisation 60 Unit of competency
WD560 MSS405023A Develop a levelled pull system for operations and processes 60 Unit of competency
WD576 MSS405081A Develop a proactive maintenance strategy 60 Unit of competency
WD571 MSS405060A Develop the application of enterprise control systems in an organisation 60 Unit of competency
D1035 BSBWOR502A Ensure team effectiveness 50 Unit of competency
WD518 MSS403010A Facilitate change in an organisation implementing competitive systems and practices 50 Unit of competency
WD555 MSS405013A Facilitate holistic culture improvement in an organisation 60 Unit of competency
WD575 MSS405075A Facilitate the development of a new product 60 Unit of competency
D0866 BSBMKG501B Identify and evaluate marketing opportunities 50 Unit of competency
WD551 MSS405007A Introduce competitive systems and practices to a small or medium enterprise 60 Unit of competency
WD566 MSS405040A Manage 5S system in an organisation 60 Unit of competency
D0708 BSBFIM501A Manage budgets and financial plans 50 Unit of competency
S8076 BSBCUS501C Manage quality customer service 50 Unit of competency
WD552 MSS405010A Manage relationships with non-customer external organisations 60 Unit of competency
WD554 MSS405012A Manage workplace learning 60 Unit of competency
WD562 MSS405030A Optimise cost of a product or service 60 Unit of competency
WD511 MSS402080A Undertake root cause analysis 30 Unit of competency
WD563 MSS405031A Undertake value analysis of product or process costs in terms of customer requirements 60 Unit of competency
Replaces
State Code National Code Title Type
AXG2 FDF50207 Diploma of Pharmaceutical Manufacturing Qualification
No information
Entry Requirements

Not applicable.

Traineeships and Apprenticeships
No information