Qualification details

FDF50210 - Diploma of Pharmaceutical Manufacturing (Release 3)


Usage recommendation:
The Deleted usage recommendation was implemented on 13 June 2017 to describe training components that have no replacement. Enrolments in training components and statements of attainment or qualifications issued before 13 June 2017 are valid. For any components marked as deleted after 13 June 2017, the applicable transition/teach-out periods apply. For specific questions regarding the enrolment, delivery or issuance of a statement of attainment/qualification, please contact your training regulator.
DeletedDeleted from FDF10 Food Processing17/Dec/2018
Supersedes FDF50207 - Diploma of Pharmaceutical Manufacturing30/Jan/2011

Release Status:
ReleaseRelease date
3 (this release) 06/Sep/2012
(View details for release 2) 04/Nov/2011
(View details for release 1) 31/Jan/2011

Training packages that include this qualification

Units of competency

CodeSort Table listing Units of Competency by the Code columnTitleSort Table listing Units of Competency by the Title columnEssentialSort Table listing Units of Competency by the Essential column
BSBCOM502B - Evaluate and review complianceEvaluate and review compliance Elective
BSBCOM503B - Develop processes for the management of breaches in compliance requirementsDevelop processes for the management of breaches in compliance requirements Elective
BSBCUS501C - Manage quality customer serviceManage quality customer service Elective
BSBFIM501A - Manage budgets and financial plansManage budgets and financial plans Elective
BSBMGT502B - Manage people performanceManage people performance Elective
BSBMGT515A - Manage operational planManage operational plan Elective
BSBMGT516C - Facilitate continuous improvementFacilitate continuous improvement Elective
BSBMKG501B - Identify and evaluate marketing opportunitiesIdentify and evaluate marketing opportunities Elective
BSBOHS503B - Assist in the design and development of OHS participative arrangementsAssist in the design and development of OHS participative arrangements Elective
BSBPMG510A - Manage projectsManage projects Elective
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SchemeCodeClassification value
ANZSCO Identifier 399999 Technicians And Trades Workers Nec 
ASCO (occupation type) Identifier 3999-79 Associate Professionals Nec 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 
Qualification/Course Level of Education Identifier 421 Diploma 
Taxonomy - Industry Sector N/A Pharmaceutical Production 
Taxonomy - Occupation N/A Pharmaceutical Production Manager 

Classification history

SchemeCodeClassification valueStart dateEnd date
ANZSCO Identifier 399999 Technicians And Trades Workers Nec 02/Sep/2011 
ASCO (occupation type) Identifier 3999-79 Associate Professionals Nec 02/Sep/2011 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 02/Sep/2011 
Qualification/Course Level of Education Identifier 421 Diploma 31/Jan/2011 
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Modification History

September 2012: Replacement of superseded imported Units.

November 2011: Updates to imported Units, minor edits.


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.

Pathways Information

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.

Licensing/Regulatory Information

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.

Entry Requirements

Not applicable.

Employability Skills Summary

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.

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:


Prepare and review workplace documentation to support GMP


Facilitate and monitor Good Manufacturing Practice


Facilitate contamination control


Participate in validation processes


Respond to non-conformance


Report on workplace performance


Manage people in the work area


Describe and analyse data using mathematical principles


Implement and monitor environmentally sustainable work practices



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


Identify, assess and control OHS risk in own work


Manage OHS processes


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


Operate inter-related processes in a production system


Operate inter-related processes in a packaging system


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


Schedule and manage production


Manage supplier agreements and contracts


Design and maintain programs to support legal compliance


Manage and evaluate new product trials


Manage utilities and energy for a production process


Establish and maintain a strategic planning cycle


Evaluate and review compliance


Develop processes for the management of breaches in compliance requirements


Manage people performance


Manage operational plan


Facilitate continuous improvement


Manage projects


Perform basic statistical quality control


Manage people relationships


Develop competitive systems and practices for an organisation


Develop quick changeover procedures


Determine and improve process capability*

MSS404052A Apply statistics to operational processes


Develop and manage sustainable energy practices


Develop and manage sustainable environmental practices



Manage quality customer service


Manage budgets and financial plans


Identify and evaluate marketing opportunities


Assist in the design and development of OHS participative arrangements


Ensure team effectiveness


Facilitate change in an organisation implementing competitive systems and practices


Manage relationships with non-customer external organisations


Manage workplace learning


Facilitate holistic culture improvement in an organisation


Develop a communications strategy to support operations


Analyse and map a value stream


Develop a Balanced Scorecard


Introduce competitive systems and practices to a small or medium enterprise


Apply cost factors to work practices


Undertake root cause analysis


Apply statistics to operational processes


Design a process layout


Develop a levelled pull system for operations and processes


Optimise cost of a product or service


Undertake value analysis of product or process costs in terms of customer requirements


Analyse cost implications of maintenance strategy


Manage 5S system in an organisation


Determine and establish information collection requirements and processes


Develop a documentation control strategy for an organisation


Facilitate the development of a new product*

MSS404052A Apply statistics to operational processes


Develop a proactive maintenance strategy


Adapt a proactive maintenance strategy to the process operations sector*

MSS405081A Develop a proactive maintenance strategy


Adapt a proactive maintenance strategy for a seasonal or cyclical business*

MSS405081A Develop a proactive maintenance strategy


Develop the application of enterprise control systems in an organisation