Pharmaceutical Manufacturing Standards 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


‘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.

Register your interest in the project

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

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
Julie StratfordIndustry Facilitation Manager, Skills Impact jstratford@skillsimpact.com.au
Tom VassalloIndustry Skills Standards Specialist, Skills Impact tvassallo@skillsimpact.com.au
Peter MillerSkills 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

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

 

 

Register your interest in the project

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

Drafts Available

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.

Qualifications

FBP2XX18 Certificate II in Pharmaceutical ManufacturingDownload draft qualification

 FDF30218 Certificate III in Pharmaceutical ManufacturingDownload draft qualification
 FDF40218 Certificate IV in Pharmaceutical ManufacturingDownload draft qualification

Units of Competency

 FDFPHM1001 Follow work procedures to maintain good manufacturing practice requirementsDownload draft unit

Click here to download a zipped folder of all skill sets in this group

FDFPHM3XXX Operate a granulation processDownload draft unit
FDFPHM3XXX Operate a liquid manufacturing processDownload draft unit
FDFPHM3XXX Operate a separation process using chromatographyDownload draft unit
FDFPHM3XXX Operate a tablet coating processDownload draft unit
FDFPHM3XXX Operate a terminal sterilisation processDownload draft unit
FDFPHM3XXX Operate an aseptic fill and seal processDownload draft unit
FDFPHM3XXX Operate an aseptic form, fill and seal processDownload draft unit
FDFPHM3XXX Operate an encapsulation processDownload draft unit
FDFPHM3XXX Operate an extraction processDownload draft unit
FDFPHM3XXX Participate in a pharmaceutical production environmentDownload draft unit
FDFPHM3XXX Work in a controlled environmentDownload draft unit
FDFPHM3XXX Clean and sanitise facilities and equipmentDownload draft unit
FDFPHM3XXX Coordinate a label storeDownload draft unit
FDFPHM3XXX Dispense pharmaceutical raw materialsDownload draft unit
FDFPHM3XXX Implement good manufacturing practice requirementsDownload draft unit
FDFPHM3XXX Operate a compressing processDownload draft unit
 FDFPHM3XXX Operate a concentration processDownload draft unit

Click here to download a zipped folder of all skill sets in this group

FDFPHM4004 Participate in change control proceduresDownload draft unit
FDFPHM4005 Participate in validation processesDownload draft unit
FDFPHM4006 Respond to non-conformanceDownload draft unit
FDFPHM4XXX Monitor and maintain good manufacturing practice requirementsDownload draft unit
FDFPHM4001 Prepare and review workplace documentation to support good manufacturing practice requirementsDownload draft unit
FDFPHM4003 Facilitate contamination controlDownload draft unit

Proposed for Deletion

The two qualifications and the unit listed below are proposed for deletion from the FDF10 Food Processing Training Package. The proposal to delete these qualifications and unit will result in their removal from the training package altogether and they will not be transitioned in to the FBP Food Beverage and Pharmaceutical Training Package.

FDF10210 Certificate I in Pharmaceutical ManufacturingIndustry feedback suggests that this qualification does not meet industry needs. There were four enrolments in the qualification from 2014 to 2016.
FDF50210 Diploma of Pharmaceutical ManufacturingIndustry feedback suggests that this qualification does not meet industry needs. There were no enrolments in the qualification from 2014 to 2016.
FDFPH4002A Facilitate and monitor Good Manufacturing PracticeA redesigned unit of competency FDFPH4XXX Monitor and maintain good manufacturing practice requirements has been developed to fulfil industry needs at this level.

 

Register your interest in the project

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

Validation

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.

 

Qualifications

FBP2XX18 Certificate II in Pharmaceutical ManufacturingDownload final draft qualification
 FDF30218 Certificate III in Pharmaceutical ManufacturingDownload final draft qualification
 FDF40218 Certificate IV in Pharmaceutical ManufacturingDownload final draft qualification

 

Units of Competency

FBPPHM2001 Follow work procedures to maintain good manufacturing practice requirements (formally coded as level 1)Download final draft unit

 

Click here to download a zipped folder of all skill sets in this group

FBPPHM3013 Operate a granulation processDownload final draft unit
FBPPHM3014 Operate a liquid manufacturing processDownload final draft unit
FBPPHM3015 Operate a tablet coating processDownload final draft unit
FBPPHM3016 Operate a sterilisation process using an autoclaveDownload final draft unit
FBPPHM3017 Coordinate a label storeDownload final draft unit
FBPPHM3001 Apply good manufacturing practice requirementsDownload final draft unit
FBPPHM3002 Operate a pharmaceutical production processDownload final draft unit
FBPPHM3003 Work in a controlled environmentDownload final draft unit
FBPPHM3004 Clean and sanitise facilities and equipmentDownload final draft unit
FBPPHM3005 Operate a concentration processDownload final draft unit
FBPPHM3006 Operate an extraction processDownload final draft unit
FBPPHM3007 Operate a separation process using chromatographyDownload final draft unit
FBPPHM3008 Operate an aseptic fill and seal processDownload final draft unit
FBPPHM3009 Operate an aseptic form, fill and seal processDownload final draft unit
FBPPHM3010 Operate a compressing processDownload final draft unit
FBPPHM3011 Dispense pharmaceutical raw materialsDownload final draft unit
FBPPHM3012 Operate an encapsulation processDownload final draft unit

 

Click here to download a zipped folder of all skill sets in this group

FBPPHM4004 Participate in change control proceduresDownload final draft unit
FBPPHM4005 Participate in validation processesDownload final draft unit
FBPPHM4006 Respond to non-conformanceDownload final draft unit
FBPPHM4001 Monitor and maintain good manufacturing practice requirementsDownload final draft unit
FBPPHM4002 Prepare and review workplace documentation to support good manufacturing practice requirementsDownload final draft unit
FBPPHM4003 Facilitate contamination controlDownload final draft unit

 

Proposed for Deletion

The two qualifications and the unit listed below are proposed for deletion from the FDF10 Food Processing Training Package. The proposal to delete these qualifications and unit will result in their removal from the training package altogether and they will not be transitioned in to the FBP Food Beverage and Pharmaceutical Training Package.

FDF10210 Certificate I in Pharmaceutical ManufacturingIndustry feedback indicates that this qualification does not meet industry needs. There were four enrolments in the qualification from 2014 to 2016.
FDF50210 Diploma of Pharmaceutical ManufacturingIndustry feedback indicates that this qualification does not meet industry needs. There were no enrolments in the qualification from 2014 to 2016.
FDFPH4002A Facilitate and monitor Good Manufacturing PracticeA redesigned unit of competency FDFPH4XXX Monitor and maintain good manufacturing practice requirements has been developed to fulfil industry needs at this level.

 

 

Register your interest in the project

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

 

Next stage of the project

Once industry had validated all final drafts they are submitted to the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC) for consideration and sign off. After final quality assurance of the drafts, they will be submitted to the Australian Industry and Skills Committee (AISC) to consider and approve for publication on training.gov.au.

Finalisation

On the 12 September 2018, the Australian Industry and Skills Committee (AISC) approved the Case for Endorsement for the updated and revised qualifications, skill sets and units of competency, along with a Companion Volume Implementation Guide.

The final qualifications, skill sets and units of competency are now published on training.gov.au, which means they are available for use by registered training organisations (RTOs). They are published within the FBP Food, Beverage and Pharmaceutical Training Package Version 2 (published on 18/12/2018). Click here to view the training package.

Pharmaceutical manufacturing industry qualifications and units of competency were reviewed to reflect current skills standards and practices and to align them to the skills required to apply Good Manufacturing Practice (GMP) principles and procedures.

What does this mean for training providers?

Registered training organisations (RTOs) may now apply to have the updated qualifications, skill sets and units added to their scope of registration. RTOs who already have the qualifications, skill sets and units that have been updated as part of this endorsement have 12 months to transition to deliver the updated qualifications, skill sets and units, from the date of publication. For more information, visit the Australian Skills Quality Authority (ASQA) website. 

A Companion Volume Implementation Guide has also been produced to help training providers implement the new and revised qualifications, skill sets and units. It can be downloaded from VETNet.com. 

Summary of consultation

After initial desktop research and analysis of the existing pharmaceutical manufacturing qualifications, job roles and work job functions, consultation meetings/site visits were undertaken with three large Pharmaceutical Manufacturers in Melbourne to undertake Workforce Functional Analysis. Subject Matter Experts were also identified and assisted with the review of qualification and unit content. The draft Certificate III and IV in Pharmaceutical Manufacturing and 24 related units were available for broader stakeholder feedback from 31 October – 7 December 2017, via the Skills Impact website. Further research confirmed the need for a Certificate II qualification and a draft was available for stakeholder feedback from 14 November to 7 December 2017. Stakeholder consultation workshops and webinars were arranged and promoted during November to seek feedback on the draft components. Face-to-face workshops and a webinar were conducted. Concerns raised by the Victorian State Training Authority regarding the proposed deletion of the existing Diploma of Pharmaceutical Manufacturing were considered by the Subject Matter Experts who supported the deletion of the Diploma as the job roles covered by this qualification typically require higher education qualifications (such as a Bachelor Degree in Chemistry, Chemical Engineering or Pharmacy). The validation drafts of the three qualifications and 24 units were released for broader stakeholder feedback from 11 January – 1 February 2018.

Summary of project outcomes
  • 3 qualifications in pharmaceutical manufacturing.
  • 24 units of competency.
  • Proposed deletion of 2 qualifications and 1 unit of competency.
Case for Endorsement

Please see the Case for Endorsement for more information about the work that was undertaken and why:

  Download the FBP Version 2 Case for Endorsement

Note that qualifications, skill sets and units developed out of the following projects were also approved as part of this Case for Endorsement:

Components related to sugar processing were also included in the Case for Endorsement. Initial work on these sugar qualifications and units was undertaken as part of FBP Food, Beverage and Pharmaceutical Training Package Version 1. However, to ensure the sugar qualifications and units were compliant and met industry needs, they were not submitted at that time. Instead, additional targeted consultation was held with key stakeholders to further review the sugar qualifications and units to address changes to licensing and legislation requirements around boiler operations, and review and to update qualifications to support current practices for multi-skilled sugar processing workers.

Please find below links to the final qualifications, skill sets and units on training.gov.au

 

Qualifications

FBP20418 Certificate II in Pharmaceutical ManufacturingView qualification on training.gov.au
FBP30818 Certificate III in Pharmaceutical ManufacturingView qualification on training.gov.au
FBP40518 Certificate IV in Pharmaceutical ManufacturingView qualification on training.gov.au

Units of Competency

FBPPHM2001 Follow work procedures to maintain Good Manufacturing Practice requirementsView unit on training.gov.au
FBPPHM3001 Apply Good Manufacturing Practice requirementsView unit on training.gov.au
FBPPHM3002 Operate a pharmaceutical production processView unit on training.gov.au
FBPPHM3003 Work in a controlled environmentView unit on training.gov.au
FBPPHM3004 Clean and sanitise facilities and equipmentView unit on training.gov.au
FBPPHM3005 Operate a concentration processView unit on training.gov.au
FBPPHM3006 Operate an extraction processView unit on training.gov.au
FBPPHM3007 Operate a separation process using chromatographyView unit on training.gov.au
FBPPHM3008 Operate an aseptic fill and seal processView unit on training.gov.au
FBPPHM3009 Operate an aseptic form, fill and seal processView unit on training.gov.au
FBPPHM3010 Operate a compressing processView unit on training.gov.au
FBPPHM3011 Dispense pharmaceutical raw materialsView unit on training.gov.au
FBPPHM3012 Operate an encapsulation processView unit on training.gov.au
FBPPHM3013 Operate a granulation processView unit on training.gov.au
FBPPHM3014 Operate a liquid manufacturing processView unit on training.gov.au
FBPPHM3015 Operate a tablet coating processView unit on training.gov.au
FBPPHM3016 Operate a sterilisation process using an autoclaveView unit on training.gov.au
FBPPHM3017 Coordinate a label storeView unit on training.gov.au
FBPPHM4001 Monitor and maintain Good Manufacturing Practice requirementsView unit on training.gov.au
FBPPHM4002 Prepare and review workplace documentation to support Good Manufacturing Practice requirementsView unit on training.gov.au
FBPPHM4003 Facilitate contamination controlView unit on training.gov.au
FBPPHM4004 Participate in change control proceduresView unit on training.gov.au
FBPPHM4005 Participate in validation of pharmaceutical manufacturing processesView unit on training.gov.au
FBPPHM4006 Respond to non-conformanceView unit on training.gov.au