Diploma of Pharmaceutical Manufacturing

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.

Pathways into the qualification Pathways for candidates considering this qualification include:

FDF40210 Certificate IV in Pharmaceutical Manufacturing

direct entry

relevant vocational training and/or work experience.

Pathways from the qualification After achieving this qualification, candidates may undertake a relevant Advanced Diploma qualification.

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.


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

Elective selection must include:

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 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)

NOTE: Units marked with an asterisk (*) require completion of prerequisite unit/s which is identified under the unit.


Complete the following nine (9) units:

add topic FDFPH4001A

Prepare and review workplace documentation to support GMP

add topic FDFPH4002A

Facilitate and monitor Good Manufacturing Practice

add topic FDFPH4003A

Facilitate contamination control

add topic FDFPH4005A

Participate in validation processes

add topic FDFPH4006A

Respond to non-conformance

add topic FDFPPL3002A

Report on workplace performance

add topic FDFPPL4001A

Manage people in the work area

add topic FDFTEC4007A

Describe and analyse data using mathematical principles

add topic MSAENV472A

Implement and monitor environmentally sustainable work practices



Select a minimum of one (1) Group A elective units.

add topic FDFOHS4001A

Identify, assess and control OHS risk in own work

add topic FDFOHS5001A

Manage OHS processes


Select a minimum of one (1) Group B elective units.

add topic FDFOP3003A

Operate inter-related processes in a production system

add topic FDFOP3004A

Operate inter-related processes in a packaging system


Select a minimum of six (6) Group C elective units.

add topic FDFPPL4003A

Schedule and manage production

add topic FDFPPL4007A

Manage supplier agreements and contracts

add topic FDFPPL5001A

Design and maintain programs to support legal compliance

add topic FDFTEC5001A

Manage and evaluate new product trials

add topic FDFTEC5002A

Manage utilities and energy for a production process

add topic BSBATSIM507B

Establish and maintain a strategic planning cycle

add topic BSBCOM502B

Evaluate and review compliance

add topic BSBCOM503B

Develop processes for the management of breaches in compliance requirements

add topic BSBMGT502B

Manage people performance

add topic BSBMGT515A

Manage operational plan

add topic BSBMGT516A

Facilitate continuous improvement

add topic BSBPMG510A

Manage projects

add topic MEM15001B

Perform basic statistical quality control

add topic MSACMC611A

Manage people relationships

add topic MSACMS600A

Develop a competitive manufacturing system

add topic MSACMT620A

Develop quick changeover procedures

add topic MSACMT650A

Determine and improve process capability*

add topic MSACMT452A Apply statistics to processes in manufacturing

add topic MSACMT670A

Develop and manage sustainable energy practices

add topic MSACMT671A

Develop and manage sustainable environmental practices


add topic BSBCUS501A

Manage quality customer service

add topic BSBFIM501A

Manage budgets and financial plans

add topic BSBMKG501B

Identify and evaluate marketing opportunities

add topic BSBOHS503B

Assist in the design and development of OHS participative arrangements

add topic BSBWOR502A

Ensure team effectiveness

add topic MSACMC410A

Lead change in a manufacturing environment

add topic MSACMC610A

Manage relationships with non-customer external organisations

add topic MSACMC612A

Manage workplace learning

add topic MSACMC613A

Facilitate holistic culture improvement in a manufacturing enterprise

add topic MSACMC614A

Develop a communications strategy to support production

add topic MSACMS601A

Analyse and map a value chain

add topic MSACMS605A

Develop a balanced score card for use in competitive manufacturing*

add topic MSACMS601A Analyse and map a value chain

add topic MSACMT280A Undertake root cause analysis

add topic MSACMT631A Undertake value analysis of product costs in terms of customer requirements

add topic MSACMS606A

Introduce competitive manufacturing to a small or medium enterprise

add topic MSACMT230A

Apply cost factors to work practices

add topic MSACMT280A

Undertake root cause analysis

add topic MSACMT452A

Apply statistics to processes in manufacturing

add topic MSACMT622A

Design a process layout

add topic MSACMT623A

Develop a levelled pull system of manufacturing

add topic MSACMT630A

Optimise cost of product*

add topic MSACMT631A Undertake value analysis of product costs in terms of customer requirements

add topic MSACMT631A

Undertake value analysis of product costs in terms of customer requirements

add topic MSACMT632A

Analyse cost implications of maintenance strategy

add topic MSACMT640A

Manage 5S system in a manufacturing environment

add topic MSACMT661A

Determine and establish information collection requirements and processes

add topic MSACMT662A

Develop a documentation control strategy for a manufacturing enterprise

add topic MSACMT675A

Facilitate the development of a new product*

MSACMT452 Apply statistics to processes in manufacturing

add topic MSACMT681A

Develop a proactive maintenance strategy

add topic MSACMT682A

Adapt a proactive maintenance strategy to the process manufacturing sector*

add topic MSACMT681A Develop a proactive maintenance strategy

add topic MSACMT683A

Adapt a proactive maintenance strategy for a seasonal or cyclical manufacturing operation*

add topic MSACMT681A Develop a proactive maintenance strategy

add topic MSACMT660A

Develop the application of enterprise systems in manufacturing


    Not applicable.

Entry Requirements

Not applicable.

Licensing Information

Licensing, Legislative, Regulatory or Certification Considerations There is no direct link between this qualification and licensing, legislative and/or regulatory requirements. However, an individual unit of competency may specify relevant licensing, legislative and/or regulatory requirements. In addition, all work must comply with Good Manufacturing Practice, occupational health and safety (OHS) and environmental regulations and legislation that apply to the workplace.

Employability Skills


Diploma of Pharmaceutical Manufacturing

The following table contains a summary of the Employability Skills as identified by the pharmaceutical manufacturing related industries for this qualification. This table should be interpreted in conjunction with the detailed requirements of each unit of competency packaged in this qualification. The outcomes described here are broad industry requirements that reflect skill requirements for this level.

Employability Skill

Industry/enterprise requirements for this qualification include:


Complete a range of workplace documentation and records

Select communication technologies to support work operations

Develop work instructions, specifications and procedures

Demonstrate effective and appropriate communication and interpersonal skills when dealing with people

Communicate with all people at all levels of the organisation in a professional manner

Select and apply documentation, communication and interpersonal strategies when dealing with internal and external clients

Select communication methods according to priority, cost and audience needs

Analyse and apply technical information

Analyse data and information to determine implications for work operations


Lead cooperative work relations with people of different ages, gender, race or religion

Provide leadership

Determine performance required to meet internal and external customer needs

Manage organisational processes and provide problem solving support to others

Facilitate team achievements


Investigate problem causes and implement corrective strategies

Identify and address potential and actual problems associated with work operations or in achieving work outcomes

Identify environmental features, regulations, insurance requirements, legal requirements and other factors which may affect the product or service to be provided

Use material and process knowledge to solve problems

Identify hazards and suggest control measures

Analyse food safety practices

Initiative and enterprise

Determine information gathering requirements to monitor work processes and procedures

Determine quality and other indicators of work

Identify efficient production processes

Determine and act on situations requiring further information or problem solving

Implement continuous improvement processes

Provide leadership in the workplace

Implement business development processes

Planning and organising

Identify hazards and implement appropriate hazard control measures

Demonstrate time management skills

Determine resource requirements

Determine work timelines and output targets

Optimise work processes

Conduct business planning processes


Analyse implications of relevant acts and regulations on work practices

Monitor work operations and identify and act on any quality and performance issues

Manage own time to meet deadlines

Determine workplace procedures and instructions

Conduct work reviews to determine improvement requirements


Develop learning opportunities

Be supportive, assertive and use interpersonal skills to encourage workplace learning

Identify own training needs and seek skill development if required

Gather feedback to own work to assess effectiveness in meeting objectives and integrate information into own practice

Assess work data and information to identify areas for improved performance

Maintain currency of industry skill and knowledge


Select computer software applications to perform work operations

Work with technology safely and according to workplace standards

Help others use technology efficiently and safely

Ensure readiness and operational efficiency of workplace technology