Pharmaceutical Bioprocessing Project
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Bioprocessing in the pharmaceutical manufacturing sector is a burgeoning field, attracting investments and creating job opportunities. As it involves the use of living organisms to manufacture products, bioprocessing requires more complex methods than other forms of pharmaceutical processing. With a growing workforce the industry faces a challenge in maintaining compliance to industry standards. However, there is also opportunity for innovation.The skills required by this emerging workforce are not currently addressed within the vocational education and training sector. As part of this project, the current units of competency in pharmaceutical processing will be reviewed and additional units developed where necessary in order to support the more complex compliance requirements and processing methods of bioprocessing.
Download Project Proposal (see pages 78-81) Register your interest in the projectSubscribe to the Skills Impact newsletter to keep informed about project updates and opportunities to provide input and feedback. Make sure to select ‘Food, Beverage & Pharmaceutical’ as your industry of interest. |
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Pharmaceutical bioprocessing techniques are now making it possible to treat some illnesses where no other treatments were previously available. This expanding field involves harnessing bacteria, yeast or mammalian cells for use in immunology, pharmaceutical therapies or diagnostic tests. The skills standards of those working in manufacturing and distribution of pharmaceutical bioprocessing products are unique to traditional pharmaceutical manufacturing.As pharmaceutical bioprocessing relies on the behaviour of living organisms, there are many variables to be considered in the manufacturing process. In order to get consistent results in treatment and diagnosis it is essential to mitigate product degradation, process variability and contamination. Workers in this area also require high level analytical skills to work with new technologies and interpret data.
Project Scope
This project will identify the skills standards for pharmaceutical bioprocessing manufacturing work and reflect these in vocational skills standards, supporting training opportunities in this field.Register your interest in the projectSubscribe to the Skills Impact newsletter to keep informed about project updates and opportunities to provide input and feedback. Make sure to select ‘Food, Beverage & Pharmaceutical’ as your industry of interest. |
Relevant Occupations
Relevant occupations include but are not limited to:- Manufacturing operators
- Plant operators
- Bioprocess technicians
- Quality assurance and quality control staff
- Research and development staff
- Fill finish/packaging operators
- Project managers
- Stock management and distribution staff
Project Team
| Cathy Beven | Industry Skills Standards Specialist, Skills Impact | [email protected] |
| Julie Stratford | Industry Engagement Manager, Skills Impact | [email protected] |
| William Henderson | Industry Skills Standards Developer, Skills Impact | [email protected] |
Timeline
September 2019 Initial scopingOctober 2019 to January 2020 Development of draft qualifications, skill sets and unitsMarch 2020 Drafts available for broad consultationApril 2020 Validation of final draftsMay 2020 Finalisation of Training Package componentsJune 2020 Independent Quality Assurance, and Edit and Equity review of Training Package componentsAugust 2020 IRC consideration for sign-off and submission for endorsementSubject Matter Experts
Subject Matter Experts will be drawn on throughout this project to help review units, skill sets and qualifications, and produce drafts to address the necessary skills.If you are interested in applying to be a subject matter expert and are able to volunteer your time to this project, please email details of your expertise to [email protected].Opportunities for stakeholder input
Stakeholder input is appreciated throughout the duration of this project. The documents will be drafted in consultation with Subject Matter Experts and their networks. Opportunities to provide targeted feedback will occur when the draft materials are made available in March 2020, and again for validation of final drafts in April 2020. However, your feedback is welcomed at any time, and will help us in drafting the documents. It is important that training provides a skilled and flexible workforce for the future and that qualifications, skill sets and units of competency reflect real work experience. So if you work in the sector, Skills Impact would love your input and help. Please feel free to register your interest for project updates and consultation opportunities by following the newsletter subscription link below. Alternatively, please feel free to contact the project manager, Cathy Beven on 03 9321 3526 or [email protected].Stakeholder Consultation Process
A list of key stakeholder organisations has been identified for this project. Skills Impact will ensure contact is made with each of these organisations during the development of this project to seek their involvement and their views on the draft qualifications, skill sets and units.If you are aware of an organisation that you think should be involved, please encourage them to contact the project team and/or direct them to this webpage.Of course, all and any interested industry participants are encouraged to engage in the consultation of this project, when the draft qualifications, skill sets, and units are available for feedback via this webpage and workshops that take place around Australia. Consultation is not limited to the organisations on this list. This list simply helps us to identify those organisations that, because of their industry role, size or specialty, are likely to have a key interest in the development and outcomes of this project.The Australian Food, Beverage and Pharmaceutical Product Manufacturing (IRC) will oversee this project, as part of their responsibilities to support engagement with the sector, and to ensure projects meet industry stakeholder needs.D
Pharmaceutical bioprocessing products such as vaccines, blood plasma products, and gene therapy medicine can make a fundamental difference in the lives of thousands, even millions, of people. They offer new treatment and testing options, sometimes for conditions where no treatment or test was available. Given these products rely on the behaviour of living organisms, specialist skills are required to achieve consistent results in treatment and diagnosis. Products must be handled in such a way as to mitigate product degradation, process variability and contamination. High level analytical skills to work with new technologies and interpret data are also needed.As part of this project, to identify the required skills in this space to manufacture biopharmaceuticals. Existing units of competency are being reviewed to see where skills gaps may exist. Several meetings have been held in Victoria, New South Wales and South Australia to determine the job tasks required for a future workforce. As a result of those meetings, it has been determined that existing pharmaceutical units should be updated where required.For further details about the drivers, scope and timeline of the project, click on the green project stage arrows above.
Development outcomes and next steps
Broad stakeholder consultation is scheduled to commence in mid-May 2020, when draft units will be made available for comment on this webpage. Your input is welcome, please feel free to register your interest to keep informed of project updates and when draft materials are available for feedback.Register your interest in the projectSubscribe to the Skills Impact newsletter to keep informed about project updates and opportunities to provide input and feedback. Make sure to select ‘Food, Beverage & Pharmaceutical’ as your industry of interest. |
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Pharmaceutical bioprocessing techniques harness living organisms in order to create life-saving medical treatments such as vaccines, blood plasma products and gene therapy medicine. The manufacture and distribution of these products requires specialist skills, including high level analytical abilities to work with new technologies and interpret data, as well as knowledge of how to handle delicate bacteria, yeast or mammalian cells to mitigate product degradation, process variability and contamination. This is essential in achieving consistent results in treatment and diagnosis.As organisations around the world trial potential tests and vaccines to manage the COVID-19 pandemic, it is important the pharmaceutical industry is equipped with all the expertise it may require. This includes the unique skills needed to manufacture and distribute products made using pharmaceutical bioprocessing techniques.
| Unit code and name | Proposed changes or rationale | Link |
| FBPPHM3005 Operate a concentration process | Foundation skills amendedAssessment Conditions clarified | View unit |
| FBPPHM3006 Operate an extraction process | Foundation skills updatedKnowledge Evidence updatedAssessment Conditions updated | View unit |
| FBPPHM3007 Operate a separation process using chromatography | Foundation skills amendedPerformance criteria clarifiedAssessment Conditions updated | View unit |
| FBPPHM3008 Operate an aseptic fill and seal process | Foundation skills amendedAssessment Conditions clarified | View unit |
| FBPPHM3009 Operate an aseptic form, fill and seal process | Foundation skills amendedAssessment Conditions clarified | View unit |
| FBPPHM3011 Dispense pharmaceutical raw materials | Foundation skills amendedAssessment Conditions clarified | View unit |
| FBPPHM3014 Operate a liquid manufacturing process | Foundation skills amendedAssessment Conditions clarified | View unit |
| FBPPHM3016 Operate a sterilisation process using an autoclave | Foundation skills amendedAssessment Conditions clarified | View unit |
| FBPPHM4003 Facilitate contamination control | Foundation skills amended | View unit |
Consultation to date
The draft units have been revised in consultation with Subject Matter Experts. People working directly in the pharmaceutical industry have provided information on the skills and knowledge required for job roles and tasks. Site visits were undertaken to observe these job roles in workplaces. This included a visit to a manufacturer to observe how they process blood plasma into life-saving pharmaceuticals, a tour of a biologics training facility, and a visit to a second manufacturer in a different state. Thank you to those who provided feedback during these activities.Register your interest in the projectSubscribe to the Skills Impact newsletter to keep informed about project updates and opportunities to provide input and feedback. Make sure to select ‘Food, Beverage & Pharmaceutical’ as your industry of interest. |
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Pharmaceutical bioprocessing techniques can be used to create life-saving and enhancing medical treatments such as vaccines, blood plasma products and gene therapy medicine. Specialist skills are needed to manufacture and distribute these products, as they contain delicate bacteria, yeast or mammalian cells prone to degradation, variation and contamination. High level analytical capabilities are also required for working with new technologies and interpreting data. This is a critical step in the supply chain, putting science into action to produce products for treatment and diagnosis and making them available for use.With pharmaceutical companies playing a key role in the management of the COVID-19 pandemic, through development of potential tests, treatments and vaccines, it is important manufacturers are equipped with all the expertise they may require. This includes the unique skills used in producing and distributing products made using pharmaceutical bioprocessing techniques.
Key Questions
- Feedback was sought as to whether there is need for a qualification specifically for bioprocessing in pharmaceutical manufacturing. At the time of Validation, there had been a suggestion that a qualification is required to help with future training, offering a training pathway that focuses on the practical application of skills, with many workers currently following a university pathway. Feedback had also been received that there is no need for a qualification or skill set, that the units are enough.
- Industry input was also sought on whether the units should be broadened to include generic statements about regulations rather than making direct reference to Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP). Feedback received prior to validation indicated that not all facilities use these terms, complying to other regulatory requirements and/or standards (for example, ISO standards), and that units of competency that discuss compliance should be updated to use more inclusive, generic terminology (for example, ‘regulatory requirements’ or ‘standards’).
Summary of consultation to date
Thank you to those stakeholders who provided feedback on the drafts that were made available from 15 May – 14 June 2020, under the ‘Drafts Available’ stage. During this time, feedback was collected via the online feedback hub, a webinar, and email. The units were drafted with guidance from industry experts. People working directly in the pharmaceutical industry have provided information on the skills and knowledge required for job roles and tasks. Site visits were undertaken to observe these job roles in workplaces. This included a visit to a manufacturer to observe how they process blood plasma into life-saving pharmaceuticals, a tour of a biologics training facility, and a visit to a second manufacturer in a different state. Thank you to those who provided feedback during these activities.A description of how feedback has been considered and applied in these final drafts can be downloaded below. Please click the ‘Download Summary of Feedback, Responses and Actions’ button.
Click here to download a zipped folder of all units in this group.
| Unit code and name | Proposed changes or rationale | Link |
| FBPPHM3005 Operate a concentration process | Range of conditions revised and now states “should include” and not, “must include”.Performance Evidence and Knowledge Evidence updatedFoundation skills amendedAssessment Conditions clarified | View final draft unit |
| FBPPHM3006 Operate an extraction process | Clarified wording in ApplicationPerformance Criteria 1.7 revisedFoundation skills updatedRange of Conditions revised and dot point addedKnowledge Evidence updatedAssessment Conditions updated | View final draft unit |
| FBPPHM3007 Operate a separation process using chromatography | Foundation skills amendedPerformance Criteria revised at 2.1, 2.3Knowledge Evidence updatedAssessment Conditions updated | View final draft unit |
| FBPPHM3008 Operate an aseptic fill and seal process | Performance Criteria revised at 1.4Foundation skills amendedRange of Conditions updated to include ‘undergarments’Performance Evidence updatedKnowledge Evidence updatedAssessment Conditions clarified | View final draft unit |
| FBPPHM3009 Operate an aseptic form, fill and seal process | Foundation skills amendedAssessment Conditions clarified | View final draft unit |
| FBPPHM3011 Dispense pharmaceutical raw materials | Foundation skills amendedAssessment Conditions clarified | View final draft unit |
| FBPPHM3014 Operate a liquid manufacturing process | Foundation skills amendedAssessment Conditions clarified | View final draft unit |
| FBPPHM30XX Operate a sterilisation process using an autoclave | Several changes to ApplicationElement 1 rewordedChanges to all Performance Criteria – 1.1, 1.2, 1.3, 1.4PC 1.5 deletedElement 2 rewordedChanges to all Performance Criteria – 2.1 deleted, 2.2, 2.3, 2.4, 2.5 reworded and renumberedChanges to all Performance Criteria – 3.1, 3.2 deleted, 3.3 revised and renumbered, 3.4 revised and renumbered, 3.5 deleted, 3.6 revised and renumberedPerformance Evidence revisedKnowledge Evidence revisedFoundation skills amendedAssessment Conditions clarified | View final draft unit |
| FBPPHM4003 Facilitate contamination control | Application revised and reworded in second paragraphChange to wording in PC 2.1Foundation skills amendedPerformance Evidence revised and updated– terminology in documents changed to include Contamination Control StrategyKnowledge Evidence revised and updated– terminology in documents changed to include product cross contamination, removed Non-viable particle limits – will be included in Implementation Guide | View final draft unit |
Register your interest in the projectSubscribe to the Skills Impact newsletter to keep informed about project updates and opportunities to provide input and feedback. Make sure to select ‘Food, Beverage & Pharmaceutical’ as your industry of interest. |
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Many life-saving and enhancing medical treatments are made using pharmaceutical bioprocessing techniques. Specialist skills are needed to manufacture and distribute these pharmaceutical products which are made from delicate bacteria, yeast or mammalian cells and must be handled carefully to minimise degradation, variation and contamination. Skills in analysis are also required for working with new technologies and interpreting data. Pharmaceutical manufacture is a critical step in the supply chain, putting science into action to produce products such as vaccines, blood plasma products and gene therapy medicines, and making them available for use.Pharmaceutical companies are also playing a key role in the COVID-19 pandemic by developing potential tests, treatments and vaccines. It is important manufacturers are equipped with all the expertise they may require, including the unique skills used in producing and distributing products made using pharmaceutical bioprocessing techniques.Thanks to the efforts of everyone who contributed to this project, nine units of competency have now been updated so that they apply to the unique context of products produced using pharmaceutical bioprocessing techniques. While changes have been minor, the units have been strengthened so that they accurately reflect current methods, materials and regulations used in pharmaceutical bioprocessing.The updated units were published on the training.gov.au website on 21 January 2021, within the FBP Food, Beverage and Pharmaceutical Training Package. They are available for use by registered training organisations (RTOs).
Bioprocessing skills are an essential and growing part of the pharmaceutical industry, with seven out of the top ten drugs by sales value globally requiring such skills for the manufacture. I know from personal experience that these skills are needed, now and in the future, in order for our pharmaceutical manufacturing sector to grow and flourish. The recent pandemic crisis has underlined this need, not just globally but within Australia, for increased pharmaceutical manufacturing capacity in order for the country to meet current and future needs more self-sufficiently. I therefore wholeheartedly support the endorsement of the Bioprocessing Technologies training units.
- Dr Paul MacLeman, foundational Cof mise degrgpFnal skills amendedAssessview and feedsions (RTOs).