Pharmaceutical Bioprocessing Project

Menu: Click across the green arrows to view active and completed project stages. Consultation takes place at every stage of the project.

Case for change

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.

This project was submitted as part of the Australian Food, Beverage and Pharmaceutical Product Manufacturing IRC Skills Forecast and Case for Change 2018-21 (see pages 78-81). However, as one of the key stakeholders CSL Behring was not available to contribute at the time, the Food, Beverage and Pharmaceutical IRC made the decision to defer the project until a later date. Given the specialised nature of this field and the emerging skills within it, the contributions of this major stakeholder were essential to the process of industry consultation.

The project was later approved by The Australian Industry and Skills Committee (AISC) out of the 2019-2022 Australian Food, Beverage and Pharmaceutical Product Manufacturing IRC Skills Forecast and Proposed Schedule of Work (see pages 3).

Skills Impact and the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC) will manage this project, consistent with the 2012 Standards for Training Package Development.

Download Project Proposal (see pages 78-81)

Register your interest in the project

Subscribe 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.

Project Plan

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.

Download project flyer

While it is evident that pharmaceutical bioprocessing requires specialised skills and knowledge, no nationally endorsed units of competency are currently available in this specific area. Consultation with industry will continue throughout this project to address the need for these skills standards. This project will include a review of current units in pharmaceutical manufacture, and potential development of new units of competency or qualifications to reflect the more in-depth analysis and compliance required for bioprocessing.

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 project

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 scoping

October 2019 to January 2020
Development of draft qualifications, skill sets and units

March 2020
Drafts available for broad consultation

April 2020
Validation of final drafts

May 2020
Finalisation of Training Package components

June 2020
Independent Quality Assurance, and Edit and Equity review of Training Package components

August 2020
IRC consideration for sign-off and submission for endorsement

Subject 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.

Development

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.

Download project flyer

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 project

Drafts Available

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.

Download project flyer

Thank you to those who provided feedback on the draft units that were made available on this webpage for feedback from 15 May – 14 June 2020. During this time, feedback was collected via the online feedback hub, a webinar, and email. The drafts, including any comments made on the feedback hub, are still available for viewing below.

Feedback will inform the work on the final drafts which are expected to available for industry validation later in June 2020.

Feedback was sought on changes to the units and whether they accurately describe the skills required to work in pharmaceutical bioprocessing manufacture. This in included feedback on updating of language where appropriate to reference ‘organic’ rather than ‘plant based’ materials to be inclusive of the use of mammalian blood in some processes. Further feedback was also sought on references to Good Manufacturing Process (GMP) in the assessment conditions and whether this is inclusive of all industry job roles and practices, as some of this sector may work in a laboratory rather than a production plant.

Units of Competency

Unit code and name	Proposed changes or rationale	Link
FBPPHM3005 Operate a concentration process	Foundation skills amended Assessment Conditions clarified	View unit
FBPPHM3006 Operate an extraction process	Foundation skills updated Knowledge Evidence updated Assessment Conditions updated	View unit
FBPPHM3007 Operate a separation process using chromatography	Foundation skills amended Performance criteria clarified Assessment Conditions updated	View unit
FBPPHM3008 Operate an aseptic fill and seal process	Foundation skills amended Assessment Conditions clarified	View unit
FBPPHM3009 Operate an aseptic form, fill and seal process	Foundation skills amended Assessment Conditions clarified	View unit
FBPPHM3011 Dispense pharmaceutical raw materials	Foundation skills amended Assessment Conditions clarified	View unit
FBPPHM3014 Operate a liquid manufacturing process	Foundation skills amended Assessment Conditions clarified	View unit
FBPPHM3016 Operate a sterilisation process using an autoclave	Foundation skills amended Assessment 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 project

Validation

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.

Download project flyer

National skills standards for this work are being reviewed and developed as part of this project. Thank you to everybody that has had input so far. They have been revised to include work functions that reflect current job roles in the industry and to incorporate the latest technologies, equipment and advances in bioprocessing in pharmaceutical manufacturing.

Thank you to those who provided feedback on the final draft units of competency for pharmaceutical bioprocessing manufacture that were made available on this page from 6 – 19 July 2020.

The final drafts will shortly progress through to the Finalisation stage of the project which includes quality assurance of the documents and review and feedback from the State/Territory Training Authorities. They will then be forwarded to the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC) for consideration and sign off, before being submitted to the Australian Industry and Skills Committee (AISC) and State/Territory Ministers to consider and approve for publication on training.gov.au.

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.

Download Summary of Feedback, Responses and Actions

Units of Competency

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 updated Foundation skills amended Assessment Conditions clarified	View final draft unit
FBPPHM3006 Operate an extraction process	Clarified wording in Application Performance Criteria 1.7 revised Foundation skills updated Range of Conditions revised and dot point added Knowledge Evidence updated Assessment Conditions updated	View final draft unit
FBPPHM3007 Operate a separation process using chromatography	Foundation skills amended Performance Criteria revised at 2.1, 2.3 Knowledge Evidence updated Assessment Conditions updated	View final draft unit
FBPPHM3008 Operate an aseptic fill and seal process	Performance Criteria revised at 1.4 Foundation skills amended Range of Conditions updated to include ‘undergarments’ Performance Evidence updated Knowledge Evidence updated Assessment Conditions clarified	View final draft unit
FBPPHM3009 Operate an aseptic form, fill and seal process	Foundation skills amended Assessment Conditions clarified	View final draft unit
FBPPHM3011 Dispense pharmaceutical raw materials	Foundation skills amended Assessment Conditions clarified	View final draft unit
FBPPHM3014 Operate a liquid manufacturing process	Foundation skills amended Assessment Conditions clarified	View final draft unit
FBPPHM30XX Operate a sterilisation process using an autoclave	Several changes to Application Element 1 reworded Changes to all Performance Criteria – 1.1, 1.2, 1.3, 1.4 PC 1.5 deleted Element 2 reworded Changes to all Performance Criteria – 2.1 deleted, 2.2, 2.3, 2.4, 2.5 reworded and renumbered Changes 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 renumbered Performance Evidence revised Knowledge Evidence revised Foundation skills amended Assessment Conditions clarified	View final draft unit
FBPPHM4003 Facilitate contamination control	Application revised and reworded in second paragraph Change to wording in PC 2.1 Foundation skills amended Performance Evidence revised and updated– terminology in documents changed to include Contamination Control Strategy Knowledge 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 project

Finalisation

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 Chair of the Pharmaceutical Industry Reference Committee and Chairman of AdAlta Ltd

Key Outcomes

Nine units of competency were updated to accurately describe the skills required to work in pharmaceutical bioprocessing manufacture. Feedback was sought on the need for a qualification specific to the manufacture of pharmaceuticals using bioprocessing techniques, but the majority of those who contributed indicated that it was not required at this time.

Updates have been made to terminology so that the units are current and accurate to the context of pharmaceutical bioprocessing. This includes:

The term ‘plant based’ materials has been replaced with ‘organic’ materials to be inclusive of the use of mammalian blood in some processes.
The application of the unit of competency FBPPHM3018 Operate a sterilisation process using an autoclave has been updated to include other accreditation or certification requirements, enabling it to be used across many other training packages and settings. The second paragraph now reads: “The unit applies to individuals who apply Good Manufacturing Practice (GMP) or other accreditation or certification requirements if relevant in other industries/settings, and operating principles to the terminal sterilisation of product and sterilisation of goods for aseptic processing using an autoclave”.
FBPPHM3007 Operate a separation process using chromatography has been renamed FBPPHM3019 Operate a chromatography manufacturing process.

Summary of consultation to date

The units and skill sets were developed with guidance from a group of Subject Matter Experts (SMEs), made up of people working directly in the pharmaceutical industry. 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. The broader industry were then consulted on the draft documents at two different stages – the ‘Drafts Available’ and ‘Validation’ stages – with feedback collected via the online feedback hub, a webinar, and email. At least 12 consultation meetings have occurred throughout the project, including public consultation and validation meetings. The COVID-19 epidemic has been a challenging factor throughout the project in 2020 so meetings have been conducted online and via telephone. Skills Impact would like to thank everyone involved throughout.

A summary of feedback and how it was been considered and applied at the ‘Drafts Available’ and ‘Validation’ stages can be downloaded below.

Round 1 (Drafts Available) Summary

Round 2 (Validation) Summary

The units of competency were endorsed by the Australian Industry and Skills Committee (read the communique) and State and Territory Ministers after undergoing an edit and equity and independent quality assurance process and consideration by the State/Territory Training Authorities (STAs/TTAs). A Case for Endorsement was submitted alongside the draft units, including a rationale of why these changes are needed and evidence of industry support.

Click here to download the Case for Endorsement

Please find below links to the final documents, that are published on the training.gov.au website.

Companion Volume Implementation Guide

A Companion Volume Implementation Guide has also been produced to assist industry and registered training providers (RTOs) deliver the units. It contains key information to help trainers adapt to the new changes, and additional information about the impacts of regulation and licensing implications and workplace health and safety on their training.

Download Part 1: Overview and Implementation

Download Part 2: Component Details