Pharmaceutical GMP 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

The pharmaceutical manufacturing industry relies on good manufacturing practice (GMP) systems to produce products to high quality standards. Industry has indicated that three pharmaceutical manufacturing qualifications currently contain GMP units that need updating to improve accessibility and check alignment with the Australian Qualifications Framework (AQF). At the same time, business units within the Certificates III and IV in Pharmaceutical Manufacturing have been superseded and need to be replaced with the current versions so that training delivery reflects current practices.

The Australian Industry Skills Committee (AISC) approved this project, out of the Annual Update IRC Skills Forecast and Proposed Schedule of Work.

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

Download Project Proposal (see page 54)

Project Plan

Good manufacturing practice (GMP) is a vital tool for maintaining quality and consistency in the pharmaceutical industry, where there is no room for error. The skills to understand and work with GMP is a requirement of the workforce, as licensing to produce pharmaceuticals is dependent on maintaining compliance with GMP codes. Industry feedback has indicated that the current units of competency for pharmaceutical GMP do not accurately reflect the necessary skills. Some are also missing references to important validation processes required for GMP and one refers to international standards that are not relevant to all contexts where GMP is used.

With strong support and funding for Australia’s pharmaceutical manufacturing industry in response to the COVID-19 pandemic, it is important that units are updated so that learners can take advantage of opportunities in the sector. This is also important for industry as it builds towards greater sovereign capability so that Australia can manufacture more of its own vaccines and life-saving treatments.

Consultation will take place as part of this project, so that the GMP units within three pharmaceutical manufacturing qualifications are up to date, accessible and reflect the appropriate Australian Qualifications Framework (AQF) level. This will allow future learners to access the skills they require to produce safe and effective pharmaceuticals for the Australian public. It will also improve the transferability of the skills described within the units, so that the units reflect skills that would be valuable in any manufacturing role.

Project Scope

Consultation will take place to update up to three qualifications, one skill set and four units that refer to the skills required for pharmaceutical GMP.

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Relevant Occupations
  • Pharmaceutical production operators
  • Formulator operators
  • Reagent formulator operators
  • Online sampling operators
  • Fillers and packers
  • Pharmaceutical machine and process operators

 

Project Team
William HendersonIndustry Skills Standards Specialist, Skills Impactwilliam@skillsimpact.com.au
Julie StratfordIndustry Engagement Manager, Skills Impactjstratford@skillsimpact.com.au

 

Timeline

August 2021
Initial scoping

September 2021
Development of draft qualifications, skill sets and units

September/October 2021
Drafts available for broad consultation

November 2021
Validation of final drafts

January/February 2022
Finalisation of Training Package components

February/March 2022
Independent Quality Assurance, and Edit and Equity review of Training Package components

April 2022
IRC consideration for sign-off and submission for endorsement

Opportunities for stakeholder input

Those with experience and knowledge in pharmaceutical GMP, who are able to describe the skills needed for this industry are invited to engage with this project.

It is important that training provides a skilled and flexible workforce for the future. The units need to reflect real work experience. So, if you work in the sector, Skills Impact welcomes your input and assistance.

The skills standards will be drafted in consultation with Subject Matter Experts and their networks. Opportunities to provide targeted feedback will occur when the draft skills standards are made available in September/October, and again for validation of final drafts in November. However, your feedback is welcomed at any time, and will help us in drafting the qualifications, skill set and units.

Please register your interest in project updates and consultation opportunities by contacting the project manager, William Henderson william@skillsimpact.com.au. You are also welcome to subscribe to our newsletter for regular updates about the project.

N.B. webinars will be held to replace face-to-face consultation workshops where necessary due to COVID-19 related restrictions.

Stakeholder Consultation Process

A list of key stakeholder organisations has been identified for this project based on their industry role, size or specialty. Skills Impact will ensure contact is made with each of these organisations to seek their involvement and views on all draft skill sets and units. Consultation is not limited to the organisations on this list, they have simply been identified as the most, likely to have a key interest in the development and outcomes of this project

If you are aware of an organisation that you think should be involved, please contact the project team to ensure they are contacted by us.

Development

Skills in Good Manufacturing Practice (GMP) are critical to Australia’s pharmaceutical manufacturing industry, providing a framework through which to maintain the quality and consistency of pharmaceutical products. In order to hold a license to produce pharmaceuticals, businesses must maintain compliance with GMP codes. It is important that the skills standards that support pharmaceutical GMP are kept up to date, so that industry can access the skilled workforce it needs and new entrants can be equipped with the necessary expertise.

Work is being undertaken to update four national units of competency that support this sector. They are being revised in consultation with industry experts, workplaces and registered training organisations who use the current units in their workplace or deliver the training. Feedback has indicated that the four units require updating to reflect relevant Australian Qualifications Framework (AQF) skill levels and contexts for GMP. Proposed changes so far have included the removal of some GMP knowledge requirements specific to overseas governing bodies, as the training needs to be suitable for Australian workplaces.

With the COVID-19 pandemic highlighting the important role pharmaceutical manufacturing has in creating life-saving treatments, it is important the units are updated to reflect the current required skills to manufacture high-quality products. These updated units will also support future learners with the skills they need to take advantage of opportunities within the sector.

Development Outcomes and Next Steps

Broad stakeholder consultation is scheduled to commence later in September 2021, when draft units will be made available for comment on this webpage. Your input is welcome. Please register your interest in project updates and consultation opportunities by contacting the project manager, William Henderson william@skillsimpact.com.au. You are also welcome to subscribe to our newsletter for regular updates about the project.

Subscribe to updates about 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 and Pharmaceutical’ as your industry of interest.

 

Drafts Available

Australia’s pharmaceutical production workforce relies on Good Manufacturing Practice (GMP) to produce high quality and consistent vaccines and treatments. GMP provides a set of principles that underpins all work done in the sector, with licensing dependent on maintaining compliance with GMP codes. As such it is crucial that the units that support skills in pharmaceutical GMP are kept up to date, giving industry and individual learners may access training that reflects the necessary expertise.

Industry feedback has indicated the need to update four pharmaceutical units that describe skills for GMP, as they do not reflect the level and context of the work functions that they need to describe. Consultation has taken place with industry experts in pharmaceutical GMP to update the units so that they reflect the appropriate level of skill required in Australian pharmaceutical manufacturing workplaces.

Thank you to those who provided feedback on updated draft units that were made available on this webpage for feedback and comment from 23 September until 2 November 2021. Feedback was invited about whether the documents accurately reflect current job practices and functions. We especially sought feedback on the amount of evidence specified within the Performance Evidence sections of these drafts. Previously the language used for how a student would provide evidence of their performance was that they ‘Must demonstrate competency on at least one occasion’. Further suggestions were encouraged for replacement language that demonstrates how many times a task must be performed for a student to be considered competent. Feedback was also sought on the removal of references to the United States Food and Drug Administration (FDA) and European standards, which are proposed to be removed from the Knowledge Evidence of one unit based on industry feedback.

Your feedback will inform the work on the final drafts which will be available for industry validation in November 2021. You can still view the documents and any comments made below.

Units of Competency

Unit code and nameProposed changes or rationaleLink
FBPPHM3XXX Apply Good Manufacturing Practice requirementsRemoval of Knowledge Evidence not specific to work undertaken in Australia, changes to Performance Evidence volume of learning statement.View draft unit
FBPPHM3XXX Operate a pharmaceutical production processChanges to Performance Evidence volume of learning statement.View draft unit
FBPPHM2001 Follow work procedures to maintain Good Manufacturing Practice requirementsChanges to Performance Evidence volume of learning statement.View draft unit
FBPPHM4001 Monitor and maintain Good Manufacturing Practice requirementsChanges to Performance Evidence volume of learning statement.View draft unit

The draft documents can be downloaded in Microsoft Word format by clicking here.

Summary of Consultation to Date

The draft units have been drafted in consultation with Subject Matter Experts (SMEs). They have considered feedback that was received out of an SME meeting during September 2021. People working directly in the pharmaceutical sector participated and provided information on the skills and knowledge required for job roles and tasks. Thank you to those who provided feedback during these activities.

 

Subscribe to updates about 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 and Pharmaceutical’ as your industry of interest.

 

Validation

Skills in Good Manufacturing Practice (GMP) are essential for producing high quality and consistent vaccines and treatments. Licensing in the industry is dependent on maintaining compliance with GMP codes. Therefore, it is critical that the units of competency that support skills in pharmaceutical GMP are kept up to date, so that learners can be equipped with the expertise currently required by industry.

Consultation is taking place to update four pharmaceutical units that describe skills for GMP so that they reflect the level and context of the work functions they describe.

Thank you to everyone who provided feedback on the final draft units of competency that were made available for validation and comment from 12 November to 10 December 2021. You can still view the documents and any comments made below.

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 Industry Reference Committee for consideration and sign off, before being submitted to the Australian Industry and Skills Committee (AISC) and State and Territory Ministers to consider and approve for publication on training.gov.au.

Summary of feedback and key changes

The final drafts incorporated feedback that was received on the initial drafts that were made available between 28 September and 2 November 2021, under the ‘Drafts Available’ stage. During this time, feedback was collected via the online feedback hub, consultation webinars, phone and email. The units were drafted with guidance from subject matter experts, made up of workplace experts and industry. During the ‘Drafts Available’ phase, industry recommended the inclusion of the Therapeutic Goods Act and The GMP Code of Practice, and that industry Manufacturing Principles be retained in the knowledge evidence section of the units. Broader industry also responded positively to the initial changes recommended by the subject matter expert working group.

The draft units were revised to best reflect current industry practice, remove duplication of information within units and to align with current Australian GMP requirements. Adjustments were made to the language used for how a student would provide evidence of their performance in each unit. Previously it was stated that learners ‘Must demonstrate competency on at least one occasion’. This has been amended to read ‘on one or more occasions’. Based on industry feedback to date, references to the Therapeutic Goods Act and GMP Code of Practice have been included in the drafts where applicable and references to industry Manufacturing Principles have been retained in the knowledge evidence section of the units.

A description of how feedback from the ‘Drafts Available’ phase was considered and applied in these final drafts can be downloaded below. Please click the ‘Download Summary of Feedback, Responses and Actions’ button.

Units

Unit code and nameProposed changes or rationaleLink
FBPPHM2001 Follow work procedures to maintain Good Manufacturing Practice requirements
  • Performance Evidence volume of learning wording updated to read that each dot point must be demonstrated ‘on one or more occasions’.
  • Performance Criteria 1.2 deleted
View final draft unit
FBPPHM3XXX Apply Good Manufacturing Practice requirements
  • Performance Evidence volume of learning wording updated to read that each dot point must be demonstrated ‘on one or more occasions’.
  • TGA, Manufacturing Principles and GMP Code of practice re-introduced
  • Element 1 retitled
  • Element 3 deleted
View final draft unit
FBPPHM3XXX Operate a pharmaceutical production process
  • Performance Evidence volume of learning wording updated to read that each dot point must be demonstrated ‘on one or more occasions’.
View final draft unit
FBPPHM4001 Monitor and maintain Good Manufacturing Practice requirements
  • Performance Evidence volume of learning wording updated to read that each dot point must be demonstrated ‘on one or more occasions’.
View final draft unit

 

The draft documents can be downloaded in Microsoft Word format by clicking here.

 

Subscribe to updates about 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 and Pharmaceutical’ as your industry of interest.

 

Finalisation

A workforce with skills in pharmaceutical Good Manufacturing Practice (GMP) is essential as the Australian pharmaceutical industry builds towards greater sovereign capability in producing vaccines and life-saving treatments. The principles of GMP underpin all work done in the sector, with site or company licensing dependent on maintaining compliance with GMP codes. It is important that the skills standards that support GMP are kept up to date so that new entrants can be equipped with the necessary expertise.

Industry feedback indicated that the current pharmaceutical GMP units did not accurately reflect the necessary skills. Some were missing references and important validation processes required for GMP and there were references to standards not relevant to all contexts.

As part of consultation throughout this project, recommendations were made to streamline four units to better reflect industry needs, including the removal of knowledge evidence and performance criteria where required. Industry will now have access to units that better reflect the actual job tasks undertaken by graduates and that have fewer barriers in their deliverability. This will allow current and future learners to gain the skills they require to produce safe and effective pharmaceuticals for the Australian public.

Overall, this review focused on improving skills standards to better reflect compliance requirements, job function, skill transferability and industry needs for the pharmaceutical sector. The updated units were published on the national training register (training.gov.au) within the Food, Beverage and Pharmaceutical Training Package on 20 April 2022.

Thank you to everyone who was involved in this project to improve these critical units.

Summary of consultation

Industry consultation with subject matter experts, workplaces and registered training organisations has taken place as part of this project. As a result of this consultation, four GMP units for the pharmaceutical sector were updated so that they reflect the level and context of the work functions they describe.

There was engagement from all the states and territories where industry is particularly active, including Queensland, New South Wales, South Australia and Victoria. Four webinar workshops were held during the Drafts Available period with feedback supporting the changes suggested by subject matter experts.

Overall, 28 stakeholders offered their feedback on the project.

The final draft units of competency have been 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 of competency, including a rationale of why these changes are needed and evidence of industry support. A Companion Volume Implementation Guide has also been produced to assist industry and registered training providers (RTOs) deliver the units of competency. 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.

Please find below links to the final documents that are published on the national training register.

Click here to download the Case for Endorsement

Click here to download the Companion Volume Implementation guide Part 1

Click here to download the Companion Volume Implementation guide Part 2

Units of Competency

Unit code and name
FBPPHM3020 Apply Good Manufacturing Practice requirements
FBPPHM3021 Operate a pharmaceutical production process
FBPPHM2001 Follow work procedures to maintain Good Manufacturing Practice requirements
FBPPHM4001 Monitor and maintain Good Manufacturing Practice requirements

Subscribe to updates about the project

Subscribe to the Skills Impact newsletter to keep informed about project updates. Make sure to select ‘Food, Beverage and Pharmaceutical’ as your industry of interest on the subscription form.