Download the IRC Skills Forecast (see page 53)

Project Scope

This project will review units of competency and qualifications in the pharmaceutical manufacturing industry to reflect current skills standards and practices, so that all job functions are accurately described. A focus of the project will be to align the units, skill sets and qualifications to the skills required to apply Good Manufacturing Practice (GMP) principles and procedures.

Scroll down to view the list of units and qualifications that will be reviewed in this project, and the various skilled activities they cover.

Pharmaceutical manufacturing is highly specialised, requiring differing degrees of training based on the complexity of processes. Although different roles and organisations differ in their complexity and therefore the skills required to perform tasks, GMP provides a common skills-base for entry-level pharmaceutical production workers. A Victorian GMP qualification and related units have been developed to fill skill gaps surrounding GMP requirements, but it has not yet been tested nationally. This project will review this qualification, to identify industry requirements and GMP elements, to develop a national GMP qualification. Skill gaps identified during the review process will identify any additional work for the development of units of competency and skill sets.

Relevant Occupations

Production staff, supervisors and managers.

Key Deliverables

The review will consider:

• 5 existing qualifications and associated packaging rules
• 22 units of competency
• Development of new Training Package components
• Rationalisation of qualifications
• Updating entry-level units of competency for production operators to address Good Manufacturing Practice requirements

The exact number of units, skill sets and qualifications that will be reviewed, drafted and developed in this project will be determined during the initial functional analysis and review.

Timeline

September 2017
Initial scoping, including workforce functional analysis

October 2017
Review process commencement

November 2017
Industry consultation of draft materials

January 2018
Industry validation of final drafts

February 2018
Finalisation of Training Package components

March – April 2018
Independent Quality Assurance, and Edit and Equity review of Training Package components

April 2018
IRC consideration for sign-off and submission for endorsement

Project Team

Subject Matter Experts

Subject Matter Experts will be drawn on throughout this project to help review and draft the revised units, skill sets and qualifications.

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:

Below is a list of the current and existing qualifications and units that will be reviewed as part of this project. Use the links below to view the components on training.gov.au.

We invite you to provide your input on the current qualifications and units. We would like to know what changes or updates should be made to the components so that they meet the skills needs of the industry. We are particularly interested in hearing about how the current qualifications and units reflect:

• the level and complexity of job roles within the industry
• current Good Manufacturing Practice (GMP)
• quality concerns regarding industry auditing and compliance and the GMP
• requirements for cleaning and sanitising facilities and equipment, working in controlled environments and participating in pharmaceutical production
• the low enrolments in some of these qualifications and units.

Your feedback will help us in drafting the revised qualifications and units.

To provide feedback, please use our feedback form. Alternatively, you can email Tom Vassallo [email protected]

Consultation workshops with Subject Matter Experts and site visits/meetings with representatives of the pharmaceutical manufacturing industry are underway to establish the main roles and work functions in the industry. This consultation will inform the development of revised draft qualification and units of competency for the  pharmaceutical manufacturing industry.

Development of the draft qualification and units will be completed by the end of October and will be available for download and comment from this webpage by early November.

Face-to-face consultation workshops will also take place in November in the capital cities listed below, with a webinar planned for those unable to attend in person. Please feel free to register for a workshop near you or a webinar by clicking the corresponding link.

Face-to-Face Consultation Workshops

8 Nov 17, 10:00 – 12:00 – Melbourne, VIC – register here

9 Nov 17, 13:00 – 15:00 – Adelaide, SA – register here

10 Nov 17, 11:00 – 13:00 – Sydney, NSW – register here

22 Nov 17, 14:30 – 16:30 – Brisbane, QLD – register here

Consultation Webinar

14 Nov 17, 14:00 – 15:00 AEST – Webinar – register here

1 Dec 17, 10:00 – 11:00 – Webinar – register here

Thank you to all those who provided feedback on the draft qualifications and units of competency. The drafts were made available on the Skills Impact website from 31 October – 7 December 2017. Several face-to-face consultation workshops and two webinars also took place throughout November.

The qualifications and units were re-written to incorporate the skills required to apply Good Manufacturing Practice (GMP) principles and procedures. Feedback was sought on whether the drafts reflect the current skills standards and practices of industry, and whether job functions are accurately described. The feedback will inform the work on the final drafts, which will be available for industry validation in January 2018.

The draft qualifications and units that were available for industry review and feedback are listed below.

Thank you to those who participated in the validation process for the final draft qualifications and units of competency. The final drafts were made available on the Skills Impact website from 11 January 2017 – 1 February 2018. 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, before the final drafts are forwarded to the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC) for consideration and sign off. They will then be submitted to the Australian Industry and Skills Committee (AISC) to consider and approve for publication on training.gov.au.

Validation means checking and confirming that the documents are logical and factually accurate. They have been re-written to incorporate the skills required to apply Good Manufacturing Practice (GMP) principles and procedures.

The final draft qualifications and units that were available for industry validation are listed below. A summary of the feedback that was received during the consultation period (between 31 October – 7 December 2017) and a description of its consideration and application in these final drafts can also be downloaded below.

Download Summary of Feedback, Responses and Actions