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 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

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 Manufacturing Download draft qualification

 FDF30218 Certificate III in Pharmaceutical Manufacturing Download draft qualification
 FDF40218 Certificate IV in Pharmaceutical Manufacturing Download draft qualification

Units of Competency

 FDFPHM1001 Follow work procedures to maintain good manufacturing practice requirements Download draft unit

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

FDFPHM3XXX Operate a granulation process Download draft unit
FDFPHM3XXX Operate a liquid manufacturing process Download draft unit
FDFPHM3XXX Operate a separation process using chromatography Download draft unit
FDFPHM3XXX Operate a tablet coating process Download draft unit
FDFPHM3XXX Operate a terminal sterilisation process Download draft unit
FDFPHM3XXX Operate an aseptic fill and seal process Download draft unit
FDFPHM3XXX Operate an aseptic form, fill and seal process Download draft unit
FDFPHM3XXX Operate an encapsulation process Download draft unit
FDFPHM3XXX Operate an extraction process Download draft unit
FDFPHM3XXX Participate in a pharmaceutical production environment Download draft unit
FDFPHM3XXX Work in a controlled environment Download draft unit
FDFPHM3XXX Clean and sanitise facilities and equipment Download draft unit
FDFPHM3XXX Coordinate a label store Download draft unit
FDFPHM3XXX Dispense pharmaceutical raw materials Download draft unit
FDFPHM3XXX Implement good manufacturing practice requirements Download draft unit
FDFPHM3XXX Operate a compressing process Download draft unit
 FDFPHM3XXX Operate a concentration process Download draft unit

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

FDFPHM4004 Participate in change control procedures Download draft unit
FDFPHM4005 Participate in validation processes Download draft unit
FDFPHM4006 Respond to non-conformance Download draft unit
FDFPHM4XXX Monitor and maintain good manufacturing practice requirements Download draft unit
FDFPHM4001 Prepare and review workplace documentation to support good manufacturing practice requirements Download draft unit
FDFPHM4003 Facilitate contamination control Download 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 Manufacturing Industry 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 Manufacturing Industry 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 Practice A 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 Manufacturing Download final draft qualification
 FDF30218 Certificate III in Pharmaceutical Manufacturing Download final draft qualification
 FDF40218 Certificate IV in Pharmaceutical Manufacturing Download 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 process Download final draft unit
FBPPHM3014 Operate a liquid manufacturing process Download final draft unit
FBPPHM3015 Operate a tablet coating process Download final draft unit
FBPPHM3016 Operate a sterilisation process using an autoclave Download final draft unit
FBPPHM3017 Coordinate a label store Download final draft unit
FBPPHM3001 Apply good manufacturing practice requirements Download final draft unit
FBPPHM3002 Operate a pharmaceutical production process Download final draft unit
FBPPHM3003 Work in a controlled environment Download final draft unit
FBPPHM3004 Clean and sanitise facilities and equipment Download final draft unit
FBPPHM3005 Operate a concentration process Download final draft unit
FBPPHM3006 Operate an extraction process Download final draft unit
FBPPHM3007 Operate a separation process using chromatography Download final draft unit
FBPPHM3008 Operate an aseptic fill and seal process Download final draft unit
FBPPHM3009 Operate an aseptic form, fill and seal process Download final draft unit
FBPPHM3010 Operate a compressing process Download final draft unit
FBPPHM3011 Dispense pharmaceutical raw materials Download final draft unit
FBPPHM3012 Operate an encapsulation process Download final draft unit

 

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

FBPPHM4004 Participate in change control procedures Download final draft unit
FBPPHM4005 Participate in validation processes Download final draft unit
FBPPHM4006 Respond to non-conformance Download final draft unit
FBPPHM4001 Monitor and maintain good manufacturing practice requirements Download final draft unit
FBPPHM4002 Prepare and review workplace documentation to support good manufacturing practice requirements Download final draft unit
FBPPHM4003 Facilitate contamination control Download 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 Manufacturing Industry 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 Manufacturing Industry 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 Practice A 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

The final draft units of competency, skill sets and qualifications, along with a Companion Volume Implementation Guide, have now been submitted to the Australian Industry and Skills Committee (AISC) as part of a Case for Endorsement for the FBP Food, Beverage and Pharmaceutical Training Package Version 2.0. It is anticipated the AISC will consider the Case for Endorsemenat their meeting on August 14.

The Case for Endorsement provides the AISC with a rationale for approving the final draft units, skill sets and qualifications. It provides information about what changes have been made to the training package including, where relevant, information on new or updated units, skill sets and qualifications. It will also outline who has been consulted and provided feedback throughout the project, why the changes were made, and what the implications of the changes are. Once endorsed, the AISC will issue a communique. The units, skill sets and qualifications will then be published on training.gov.au and available for use by registered training organisations (RTOs). Note that this Case for Endorsement also includes units, skill sets and qualifications that have been developed as part of the following projects:

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.

The AISC has endorsed these projects on the condition that Skills Impact works with IBSA Manufacturing and any other affected SSOs to prioritise the update of mapping information for any non-native units of competency identified as an appropriate and equivalent replacement. These updates will be made as an IRC Minor Update. The Food and Beverage IRC will then update any affected qualifications as part of their next Case for Endorsement.

Please find below copies of the documents that were endorsed by the AISC.

Case for Endorsement

  Download the FBP Version 2 Case for Endorsement

Companion Volume

  Download the FBP Version 2 Companion Volume Implementation Guide Part 1

  Download the FBP Version 2 Companion Volume Implementation Guide Part 2

 

Qualifications

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

FBP20418 Certificate II in Pharmaceutical Manufacturing Download final draft qualification
FBP30818 Certificate III in Pharmaceutical Manufacturing Download final draft qualification
FBP40518 Certificate IV in Pharmaceutical Manufacturing Download final draft qualification

Units of Competency

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

FBPPHM2001 Follow work procedures to maintain Good Manufacturing Practice requirements Download final draft unit
FBPPHM3001 Apply Good Manufacturing Practice requirements Download final draft unit
FBPPHM3002 Operate a pharmaceutical production process Download final draft unit
FBPPHM3003 Work in a controlled environment Download final draft unit
FBPPHM3004 Clean and sanitise facilities and equipment Download final draft unit
FBPPHM3005 Operate a concentration process Download final draft unit
FBPPHM3006 Operate an extraction process Download final draft unit
FBPPHM3007 Operate a separation process using chromatography Download final draft unit
FBPPHM3008 Operate an aseptic fill and seal process Download final draft unit
FBPPHM3009 Operate an aseptic form, fill and seal process Download final draft unit
FBPPHM3010 Operate a compressing process Download final draft unit
FBPPHM3011 Dispense pharmaceutical raw materials Download final draft unit
FBPPHM3012 Operate an encapsulation process Download final draft unit
FBPPHM3013 Operate a granulation process Download final draft unit
FBPPHM3014 Operate a liquid manufacturing process Download final draft unit
FBPPHM3015 Operate a tablet coating process Download final draft unit
FBPPHM3016 Operate a sterilisation process using an autoclave Download final draft unit
FBPPHM3017 Coordinate a label store Download final draft unit
FBPPHM4001 Monitor and maintain Good Manufacturing Practice requirements Download final draft unit
FBPPHM4002 Prepare and review workplace documentation to support Good Manufacturing Practice requirements Download final draft unit
FBPPHM4003 Facilitate contamination control Download final draft unit
FBPPHM4004 Participate in change control procedures Download final draft unit
FBPPHM4005 Participate in validation of pharmaceutical manufacturing processes Download final draft unit
FBPPHM4006 Respond to non-conformance Download final draft unit

 

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.