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Qualification details

FBP40518 - Certificate IV in Pharmaceutical Manufacturing (Release 1)

Summary

Usage recommendation:
Current
Mapping:
MappingNotesDate
Supersedes FDF40210 - Certificate IV in Pharmaceutical ManufacturingUpdated to meet Standards for Training Packages The number of units to achieve the qualification reduced from 21 to 16 Changes to packaging rules, core and elective units 17/Dec/2018

Release Status:
Current
Releases:
ReleaseRelease date
1 1 (this release) 18/Dec/2018


Units of competency

CodeSort Table listing Units of Competency by the Code columnTitleSort Table listing Units of Competency by the Title columnUsage RecommendationSort Table listing Units of Competency by the Usage Recommendation columnEssentialSort Table listing Units of Competency by the Essential column
MSS402083 - Use planning software systems in operationsUse planning software systems in operationsCurrentElective
MSMSUP390 - Use structured problem-solving toolsUse structured problem-solving toolsCurrentElective
BSBINN301 - Promote innovation in a team environmentPromote innovation in a team environmentSupersededElective
MSL922001 - Record and present dataRecord and present dataCurrentElective
BSBLDR403 - Lead team effectivenessLead team effectivenessSupersededElective
MSMWHS201 - Conduct hazard analysisConduct hazard analysisCurrentElective
BSBSMB407 - Manage a small teamManage a small teamSupersededCore
MSS403021 - Facilitate a Just in Time systemFacilitate a Just in Time systemCurrentElective
MSS403023 - Monitor a levelled pull system of operationsMonitor a levelled pull system of operationsCurrentElective
FBPPHM4001 - Monitor and maintain Good Manufacturing Practice requirementsMonitor and maintain Good Manufacturing Practice requirementsCurrentCore
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Classifications

SchemeCodeClassification value
ANZSCO Identifier 399211 Chemical Plant Operator 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 
Qualification/Course Level of Education Identifier 511 Certificate IV 
Taxonomy - Industry Sector N/A Pharmaceutical Production 
Taxonomy - Occupation N/A Pharmaceutical Production Supervisor 

Classification history

SchemeCodeClassification valueStart dateEnd date
ANZSCO Identifier 399211 Chemical Plant Operator 01/Feb/2019 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 01/Feb/2019 
Qualification/Course Level of Education Identifier 511 Certificate IV 18/Dec/2018 
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Modification History

Release 

Comments 

Release 1

This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.

Qualification Description

This qualification reflects the skills and knowledge for team leaders, supervisors and specialist technical roles within pharmaceutical manufacturing environments. The qualification includes technical skills, problem solving and supervisory skills to operate, monitor and improve the performance of pharmaceutical manufacturing systems, processes and team members.

Work must comply with good manufacturing practice, health and safety and environmental regulations and legislation that apply to the workplace.

No occupational licensing, legislative or certification requirements apply to this qualification at the time of publication.

Entry Requirements

There are no entry requirements for this qualification.

Packaging Rules

To achieve this qualification, competency must be demonstrated in:

  • 16 units of competency:
  • 8 core units, plus
  • 8 elective units.

Elective units must ensure the integrity of the qualifications’ Australian Qualification Framework (AQF) alignment and contribute to a valid, industry-supported vocational outcome. The electives are to be chosen as follows:

  • 4 must be from group A
  • 4 from the remaining units listed in groups A or B, or any currently endorsed Training Package or accredited course packaged at Certificate III, Certificate IV or Diploma, with no more than 2 units packaged at Certificate III or Diploma.

Core Units 

BSBSMB407

Manage a small team

BSBWHS401

Implement and monitor WHS policies, procedures and programs to meet legislative requirements

FBPPHM4001

Monitor and maintain good manufacturing practice requirements

FBPPHM4002

Prepare and review workplace documentation to support good manufacturing practice requirements

FBPPHM4003

Facilitate contamination control

FBPPHM4005

Participate in validation of pharmaceutical manufacturing processes

FBPPHM4006

Respond to non-conformance

FBPPPL3006

Report on workplace performance

Elective Units 

Group A 

FBPOPR3005

Operate interrelated processes in a production system

FBPOPR3006

Operate interrelated processes in a packaging system

FBPPHM3002

Operate a pharmaceutical production process

FBPPHM3003

Work in a controlled environment

FBPPHM3004

Clean and sanitise facilities and equipment

FBPPHM4004

Participate in change control procedures

FBPPPL4002

Plan and coordinate production equipment maintenance

FBPTEC4007

Describe and analyse data using mathematical principles

FBPTEC4011*

Establish process capability

MSMOPS400

Optimise process/plant area

MSMSUP406

Identify faults in electronic control

MSMWHS401

Assess risk

MSS403011

Facilitate implementation of competitive systems and practices

MSS403032

Analyse manual handling processes

MSS403085

Ensure process improvements are sustained

MSS403087

Mistake proof an operational process

MSS404052

Apply statistics to operational processes

MSS404061

Facilitate the use of SCADA systems in a team or work area

MSS404082

Assist in implementing a proactive maintenance strategy

MSS404084

Undertake process capability improvements

PMBTECH406

Diagnose production equipment problems

Group B 

BSBHRM405

Support the recruitment, selection and induction of staff

BSBINN301

Promote innovation in a team environment

BSBLDR402

Lead effective workplace relationships

BSBLDR403

Lead team effectiveness

BSBLED401

Develop teams and individuals

BSBMGT401

Show leadership in the workplace

BSBMGT402

Implement operational plan

BSBMGT403

Implement continuous improvement

BSBRES411

Analyse and present research information

BSBWOR403

Manage stress in the workplace

BSBWOR404

Develop work priorities

FBPOPR2069

Use numerical applications in the workplace

FBPOPR4001

Apply principles of statistical process control

FBPPPL3005

Participate in an audit process

MSL922001

Record and present data

MSMPER300*

Issue work permits

MSMSUP390

Use structured problem-solving tools

MSMWHS201

Conduct hazard analysis

MSS402080

Undertake root cause analysis

MSS402083

Use planning software systems in operations

MSS403010

Facilitate change in an organisation implementing competitive systems and practices

MSS403021

Facilitate a Just in Time system

MSS403023

Monitor a levelled pull system of operations

MSS403040

Facilitate and improve implementation in 5S

MSS403041

Facilitate breakthrough improvements

MSS404053

Use DMAIC techniques

MSS404060

Facilitate the use of planning software systems in a work area or team

TAEASS402

Assess competence

TAEASS403

Participate in assessment validation

TAEDEL301

Provide work skill instruction

Prerequisite requirements 

Unit of competency 

Prerequisite requirement 

FBPTEC4011 Establish process capability

FBPTEC4007 Describe and analyse data using mathematical principles

MSMPER300 Issue work permits

MSMWHS201 Conduct hazard analysis

Qualification Mapping Information

Code and title current version 

Code and title previous version 

Comments 

Equivalence status 

FBP40518 Certificate IV in Pharmaceutical Manufacturing

FDF40210 Certificate IV in Pharmaceutical Manufacturing

Updated to meet Standards for Training Packages

The number of units to achieve the qualification reduced from 21 to 16

Changes to packaging rules, core and elective units

No equivalent qualification

Links

Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4