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)

 

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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.

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

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.

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 BevenIndustry Skills Standards Specialist, Skills Impactcathy@skillsimpact.com.au
Julie StratfordIndustry Engagement Manager, Skills Impactjstratford@skillsimpact.com.au
William HendersonIndustry Skills Standards Developer, Skills ImpactWilliam@skillsimpact.com.au

 

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 cathy@skillsimpact.com.au.

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 cathy@skillsimpact.com.au.

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.

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

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.

 

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.

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.

Unit code and nameProposed changes or rationaleLink 
FBPPHM3005 Operate a concentration processFoundation skills amended

Assessment Conditions clarified

View unit
FBPPHM3006 Operate an extraction processFoundation skills updated

Knowledge Evidence updated

Assessment Conditions updated

View unit
FBPPHM3007 Operate a separation process using chromatographyFoundation skills amended

Performance criteria clarified

Assessment Conditions updated

View unit
FBPPHM3008 Operate an aseptic fill and seal processFoundation skills amended

Assessment Conditions clarified

View unit
FBPPHM3009 Operate an aseptic form, fill and seal processFoundation skills amended

Assessment Conditions clarified

View unit
FBPPHM3011 Dispense pharmaceutical raw materialsFoundation skills amended

Assessment Conditions clarified

View unit
FBPPHM3014 Operate a liquid manufacturing processFoundation skills amended

Assessment Conditions clarified

View unit
FBPPHM3016 Operate a sterilisation process using an autoclaveFoundation skills amended

Assessment Conditions clarified

View unit
FBPPHM4003 Facilitate contamination controlFoundation 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

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.

 

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.

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. 

  

Click here to download a zipped folder of all units in this group. 

 Unit code and nameProposed changes or rationale Link
FBPPHM3005 Operate a concentration processRange 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 processClarified 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 chromatographyFoundation 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 processPerformance 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 processFoundation skills amended

Assessment Conditions clarified

View final draft unit
FBPPHM3011 Dispense pharmaceutical raw materialsFoundation skills amended

Assessment Conditions clarified

View final draft unit
FBPPHM3014 Operate a liquid manufacturing processFoundation skills amended

Assessment Conditions clarified

View final draft unit
FBPPHM30XX Operate a sterilisation process using an autoclaveSeveral 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 controlApplication 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

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.

 

Finalisation

This stage has not yet commenced