Pharmaceutical Manufacturing Standards Project

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Case for change


‘Capability to understand and apply Good Manufacturing Practice (GMP) within pharmaceutical manufacturing’ was identified as a key skill priority in the 2017 Food, Beverage and Pharmaceutical IRC Skills Forecast and Proposed Schedule of Work (see page 53). In addressing this skill need, a full review of existing pharmaceutical units of competency, skill sets and qualifications will be completed. Skills Impact and the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC) will take this project through a process that adheres to the 2012 Standards for Training Package Development.

Download the IRC Skills Forecast (see page 53)

Project Plan

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.

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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
  • 1 new entry-level qualification addressing Good Manufacturing Practice standards

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
Julie Stratford Industry Facilitation Manager, Skills Impact jstratford@skillsimpact.com.au
Tom Vassallo Industry Skills Standards Specialist, Skills Impact tvassallo@skillsimpact.com.au
Peter Miller Skills Development Specialist, PEM Consulting

 

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 jstratford@skillsimpact.com.au

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 tvassallo@skillsimpact.com.au

 

Development

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Consultation

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Validation

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Finalisation

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