Unit of competency details
FBPPHM3011 - Dispense pharmaceutical raw materials (Release 2)
Summary
Companion volumes:
Unit of competency
Assessment requirements
Training packages that include this unit
Qualifications that include this unit
Classifications
Classification history
| ASCED Module/Unit of Competency Field of Education Identifier | 089901 | Purchasing, Warehousing And Distribution | 18/Dec/2018 | |
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Unit of competency
Modification History
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Release
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Comments
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Release 2
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This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 5.0.
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Release 1
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This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.
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Application
This unit of competency describes the skills and knowledge required to weigh, measure and label non-bulk ingredients to meet batch requirements in a pharmaceutical manufacturing facility.
The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the dispensing of raw materials. Individuals work under broad direction and take responsibility for their own work.
No licensing, legislative or certification requirements apply to this unit at the time of publication.
Pre-requisite Unit
Nil
Unit Sector
Pharmaceutical (PHM)
Elements and Performance Criteria
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Elements
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Performance Criteria
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Elements describe the essential outcomes.
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Performance criteria describe the performance needed to demonstrate achievement of the element.
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1. Prepare to dispense raw materials
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1.1 Confirm material status, type, quality clearance and quantities
1.2 Identify, rectify and report contamination or non-compliance issues according to workplace procedures
1.3 Confirm availability of measuring and weighing equipment to meet dispensing requirements
1.4 Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
1.5 Supply containers, bags and labels according to batch and production requirements
1.6 Conduct pre-start checks according to workplace requirements
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2. Measure and weigh raw materials
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2.1 Weigh and measure non-bulk ingredients and additives according to batch and production requirements
2.2 Monitor accuracy of measuring and dispensing equipment
2.3 Identify and report out of limit equipment operation according to workplace procedures
2.4 Label dispensed ingredients according to batch and production requirements
2.5 Maintain work area according to workplace cleaning standards
2.6 Conduct process according to workplace safety and environmental requirements
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3. Shut down the dispensing process
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3.1 Confirm the workplace procedures for shutting down the process
3.2 Safely shut down the process
3.3 Clean dispensing equipment according to workplace procedures
3.4 Report unacceptable equipment and utensil condition
3.5 Reconcile dispensed materials
3.6 Complete records according to workplace procedures
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Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential for performance in this unit of competency but are not explicit in the performance criteria.
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Skill
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Description
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Reading
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- Interpret workplace procedures for dispensing pharmaceutical raw materials
- Check and interpret raw material labels, codes and quantity
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Writing
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- Complete workplace documentation using appropriate language and in required format
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Numeracy
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- Extract and interpret mathematical information embedded in job specifications and stock control data to meet production requirements
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Unit Mapping Information
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Code and title current version
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Code and title previous version
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Comments
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Equivalence status
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FBPPHM3011 Dispense pharmaceutical raw materials Release 2
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FBPPHM3011 Dispense pharmaceutical raw materials Release 1
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Foundation skills table updated
Range of conditions deleted to remove duplication
Minor changes to assessment conditions for clarity
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Equivalent
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Links
Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4
Assessment requirements
Modification History
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Release
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Comments
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Release 2
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This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 5.0.
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Release 1
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This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.
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Performance Evidence
An individual demonstrating competency in this unit must satisfy all the elements and performance criteria of this unit.
There must be evidence that the individual has safely dispensed pharmaceutical raw materials at least once, including:
- accessed workplace information to confirm dispensing requirements
- checked supply of necessary raw materials, including:
- raw material labels and codes for status and type
- quantities
- quality clearances
- selected, fitted and used personal protective equipment and contamination prevention clothing
- conducted pre-start checks on dispensing equipment, including:
- condition and cleanliness of equipment and shared or dedicated utensils
- confirmed equipment correctly configured for dispensing requirements
- measured materials and additives within a specified accuracy range to meet batch requirements
- calculated assay or potency adjustment
- verified accuracy of raw materials dispensed with raw materials records
- taken corrective action in response to a non-conformance
- applied segregation and cross contamination prevention procedures
- paced dispensing to meet production requirements
- packed and labelled dispensed materials, according to batch requirements and labelling procedures
- reconciled and recorded materials dispensed against materials released and returned unused materials to storage
- stacked dispensed materials for transfer to designated location, ensuring required material segregation
- handled containers and maintained integrity of materials according to workplace procedures
- safely cleared the process area according to workplace procedures
- cleaned and maintained dispensing equipment, utensils and work area to meet workplace cleaning standards and environmental requirements
- completed records according to workplace procedures.
Knowledge Evidence
An individual must be able to demonstrate the knowledge required to perform the tasks outlined in the elements and performance criteria of this unit. This includes knowledge of:
- stages of the dispensing process, including:
- purpose, methods and outcomes of each stage
- control points
- types of raw materials and related handling requirements including handling of hazardous goods
- basic operating principles, requirements and parameters of dispensing equipment, including:
- measuring, and accuracy capacity of instrumentation and related equipment
- typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems
- corrective actions required where operation is outside specified operating parameters
- functions and limitations of personal protective equipment and contamination prevention clothing
- pre-start checks requirements, including:
- condition and cleanliness of equipment and shared or dedicated utensils
- confirming that equipment is correctly configured for dispensing requirements
- operational considerations that impact on the quality of the dispensing process, including:
- product accuracy
- equipment tolerances
- consequences of errors and variations
- workplace procedures for:
- calculating assay and adjusting potency
- reconciliation of raw materials, including Schedule 8 materials
- requisitioning, receiving and returning ingredients from stores
- Good Manufacturing Practice (GMP) requirements associated with dispensing pharmaceutical raw materials
- environmental issues and controls relevant to the dispensing process, including waste and rework collection, and handling procedures
- workplace systems for recording information about dispensed pharmaceutical materials, including coding and labelling systems
- requirements for completion of workplace documentation.
Assessment Conditions
Assessment of the skills in this unit of competency must take place under the following conditions:
- a pharmaceutical manufacturing workplace or an environment that accurately represents workplace conditions
- resources, equipment and materials:
- personal protective equipment and contamination prevention clothing
- dispensing process equipment and utensils
- materials required for the dispensing process
- containers or bags, labelling and storage facilities
- test equipment
- cleaning materials and equipment associated with dispensing pharmaceutical raw materials
- record keeping system
- product and intermediate product specifications, control points and processing parameters
- specifications, control points and processing parameters
- recording requirements and procedures
- workplace documentation relating to the dispensing process and procedures that comply with GMP requirements
- sampling schedules and test procedures
- cleaning procedures associated with dispensing pharmaceutical raw materials.
Assessors of this unit must satisfy the requirements for assessors in applicable vocational education and training legislation, frameworks and/or standards.
Links
Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4
