Pharmaceutical GMP Project

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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 At the same time, business units within the Certificates III and IV in Pharmaceutical Manufacturing have been superseded and need to be replaced with the current versions so that training delivery reflects current practices.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.

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 and Pharmaceutical’ as your industry of interest.

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  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.

The updated draft units are now available for feedback and comment. Your feedback is invited about whether they accurately reflect current job practices and functions. We especially are seeking 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’. We are seeking further suggestions for replacement language that demonstrates how many times a task must be performed for a student to be considered competent. Feedback is 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.

Please find the draft units listed below. You are welcome to provide feedback on as many of the draft documents as you would like. Please share these with others who may be interested in providing feedback. 

The draft qualifications and units will be available on this webpage for feedback from 23 September until 31 October 2021. 

Feedback will inform the work on the final drafts which will be available for industry validation in November 2021. 

How to provide feedback

To view the documents, please click on the expandable menus below. You can submit your feedback online using our feedback hub, or by email, or by taking part in a webinar.

Feedback hub 

You can post comments directly on the draft units, as well as view any comments from others. Your comments will remain anonymous. Only Skills Impact internal staff and training package contractors working directly on the project can identify users. For more information, see our Privacy Policy. The feedback hub is also moderated to avoid misuse. For further details, see our Moderation Policy. 

Please follow these steps:

  1. Select the unit you would like to review. 
  2. You will be asked to register or login (this is a free account). Follow the prompts. 
  3. Once logged in, you will be able to post feedback directly on the document. 
  4.  Download user instructions 

Please contact us if you require assistance. 

 Feedback via email

Of course there is always the option to email us your feedback if you prefer. You can attach the qualification or unit with your track changes as feedback, or to provide general comments about the drafts. There is a link at the bottom of each document group where you can download the Microsoft Word versions of the qualification and units. Please email your feedback to Will Henderson william@skillsimpact.com.au.

Consultation Webinars

Four consultation webinars have been set up to discuss the draft units and potential changes to them with the project team. Please register for a webinar at a time that suits you using the links below. All times are AEDT.

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 and provide feedback
FBPPHM3XXX Operate a pharmaceutical production processChanges to Performance Evidence volume of learning statement.View draft unit and provide feedback
FBPPHM2001 Follow work procedures to maintain Good Manufacturing Practice requirementsChanges to Performance Evidence volume of learning statement.View draft unit and provide feedback
FBPPHM4001 Monitor and maintain Good Manufacturing Practice requirementsChanges to Performance Evidence volume of learning statement.View draft unit and provide feedback

Alternatively, you can provide validation by emailing your feedback to william@skillsimpact.com.au

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.

 

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 and Pharmaceutical’ as your industry of interest.

 

Validation

This stage has not yet commenced

Finalisation

This stage has not yet commenced