Unit of competency Outline
Date retreived
22/07/2026 11:29 AM AWST
22/07/2026 11:29 AM AWST
Whilst all efforts are made to provide accurate and timely information from the relevant source/documentation, please be aware that the information supplied may not be the most current version. The accuracy of the detail has not been confirmed by the Department and therefore should not be relied upon without first confirming the contents.
Conduct small scale compounding and labelling of pharmaceutical products
Conduct small scale compounding and labelling of pharmaceutical products
Unit of competency
National Code
HLTPH408A
HLTPH408A
State Code
WD259
WD259
TGA Status
Replaced
Replaced
DTWD Status
Replaced
Replaced
State Implementation and Classification
Approved Date
24/08/2012
Field of Education
060501 - Pharmacy
Original Release Date
24/08/2012
Nominal Hours
50
Description
This unit of competency describes the skills and knowledge required to manufacture and small scale compounding of non-sterile pharmaceutical products from fixed formulas, including extemporaneous dispensing
Notes
Elements and Performance Criteria
Source information on formula
- 1.1 Select appropriate dosage form for product, based on client need and/or against order for medicine
- 1.2 Use validated resources to source available formulae for required product
- 1.3 Consolidate and make relevant information available
- 1.4 Confirm suitability of chosen formula and availability of resources
- 1.5 Obtain authority of pharmacist to proceed
- 1.6 Obtain and clarify the confirmed and formulated manufacturing order or master batch sheet from pharmacist, when required
Prepare for production process
- 2.1 Comply with dress code, safety and personal hygiene procedures prior to entering the work area
- 2.2 Clean work area and equipment correctly
- 2.3 Maintain inventory levels of raw materials and disposable equipment
- 2.4 Prepare a batch/work sheet referenced from a master sheet or formulae
- 2.5 Assign product batch number, if required
- 2.6 Verify that batch/work sheets are clearly written in logical order with clear directions and contain all the required information
- 2.7 Generate the product labels referenced from a master label
- 2.8 Check and note the number of labels generated
- 2.9 Submit batch/work sheet and labels to pharmacist for approval
- 2.10 Check and set up equipment
Obtain and process raw materials
- 3.1 Acquire all materials listed on the worksheet according to stock levels and stock requisitioning procedures
- 3.2 Check raw materials to ensure they have been released from quarantine for use by authorised persons
- 3.3 Verify raw materials against manufacturing work sheet and record raw material batch numbers and expiry dates
- 3.4 Weigh or measure raw materials in designated area
- 3.5 Obtain required authorisation or checks at designated points according to work sheet
Compound products
- 4.1 Allocate approved raw materials to equipment according to batch documentation
- 4.2 Compound product according to method on work sheet
- 4.3 Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications
- 4.4 Perform verification procedures, inspect finished product for deviations and report to authorised person
- 4.5 Pack compounded product into appropriate container as specified on the work sheet, and following approval from an authorised person
- 4.6 Label containers/units according to labelling specifications on the work sheet
- 4.7 Obtain required authorisation or checks at designated points
Complete production process
- 5.1 Reconcile the number of labels printed with number used and discard excess, noting and documenting discrepancies in labels
- 5.2 Place product in quarantinearea under appropriate storage conditions
- 5.3 Clean machinery and manufacturing area and dispose of disposable equipment safely
- 5.4 Complete all required documentation and forward to an authorised person
- 5.5 Report all discrepancies to an authorised person
- 5.6 Obtain final approval from the pharmacist before releasing packed medicines to storage areas
Participate in quality control
- 6.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet
- 6.2 Submit product sample and relevant documentation to quality control, where specified
- 6.3 Record and file product quality control assay results
Store and transport released product
- 7.1 Store products according to manufacturing documentation
- 7.2 Obtain released product(s) from quarantine store
- 7.3 Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product
- 7.4 Deliver product to destination
- 7.5 Advise receipting area personnel of specific storage requirements
- 7.6 Complete and file records and/or work sheets
The Range Statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Add any essential operating conditions that may be present with training and assessment depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts.
Information may include:
Equipment required
Packaging and label requirements
Preparation instructions
Raw drug materials list
Storage and stability data
Raw materials may include:
Agents considered inactive, that are required for bulking, stabilising, colouring and flavouring the final product
Therapeutic agents
Master sheet or formulae must:
Be clearly written
Be in logical order
Contain all required information
Contain no ambiguous directions
Equipment includes equipment and machinery required for manufacturing or compounding and may include:
Autoclaves
Balances
Beakers
Extractors
Filters
Gauges
Gloves
Goggles
Masks
Measures
Meters
Mixers
Needles
Ointment slabs
Pestle and mortar
Pumps
Spatulas
Stills
Syringes
Compound product may include:
Aggregation
Dissolution
Emulsification
Grinding
Mixing
Suspension
Trituration
Pack compounded product may include:
Client ready units
Bulk containers
Containers may include:
Bottles (medical and poison)
Glass jars
Miscellaneous individual client unit devices
Syringes
Tubes
Labels may be:
Electronically produced
Typed
Written
Storage conditions may include:
Ambient
Correct storage of hazardous substances
Correct temperature
Humidity
Isolated
Light
Secure and safe storage for controlled drugs
Secured
Ventilated
All required documentation may include:
Machinery and equipment records
Machinery and equipment logs
Destination may include:
Client care area
Dispensary
Store
Information may include:
Equipment required
Packaging and label requirements
Preparation instructions
Raw drug materials list
Storage and stability data
Raw materials may include:
Agents considered inactive, that are required for bulking, stabilising, colouring and flavouring the final product
Therapeutic agents
Master sheet or formulae must:
Be clearly written
Be in logical order
Contain all required information
Contain no ambiguous directions
Equipment includes equipment and machinery required for manufacturing or compounding and may include:
Autoclaves
Balances
Beakers
Extractors
Filters
Gauges
Gloves
Goggles
Masks
Measures
Meters
Mixers
Needles
Ointment slabs
Pestle and mortar
Pumps
Spatulas
Stills
Syringes
Compound product may include:
Aggregation
Dissolution
Emulsification
Grinding
Mixing
Suspension
Trituration
Pack compounded product may include:
Client ready units
Bulk containers
Containers may include:
Bottles (medical and poison)
Glass jars
Miscellaneous individual client unit devices
Syringes
Tubes
Labels may be:
Electronically produced
Typed
Written
Storage conditions may include:
Ambient
Correct storage of hazardous substances
Correct temperature
Humidity
Isolated
Light
Secure and safe storage for controlled drugs
Secured
Ventilated
All required documentation may include:
Machinery and equipment records
Machinery and equipment logs
Destination may include:
Client care area
Dispensary
Store
The evidence guide provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package.
Critical aspects for assessment and evidence required to demonstrate this competency unit:
The individual being assessed must provide evidence of specified essential knowledge as well as skills
Observation of workplace performance is desirable for assessment of this unit
Consistency of performance should be demonstrated over the required range of situations relevant to the workplace
Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible
Context of and specific resources for assessment:
Assessment should replicate workplace conditions as far as possible
Simulations may be used to represent workplace conditions as closely as possible Acceptable simulation requires:
scope to determine that work is conducted within legislative and regulatory requirements
scope to determine that work is conducted within WHS and infection control requirements
Resources essential for assessment include:
access to relevant workplace or a simulated environment where assessment can take place
instructions on the use of equipment
relevant legislation, regulations and guidelines
relevant manufacturing and packing machinery
weighing and measuring equipment
Method of assessment may include:
Formal appraisal systems
Interviewing and questioning
Observation in the work place
Supporting statement of supervisor(s)
Written assignments/projects
Access and equity considerations:
All workers in the health industry should be aware of access and equity issues in relation to their own area of work
All workers should develop their ability to work in a culturally diverse environment
In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people
Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities
Critical aspects for assessment and evidence required to demonstrate this competency unit:
The individual being assessed must provide evidence of specified essential knowledge as well as skills
Observation of workplace performance is desirable for assessment of this unit
Consistency of performance should be demonstrated over the required range of situations relevant to the workplace
Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible
Context of and specific resources for assessment:
Assessment should replicate workplace conditions as far as possible
Simulations may be used to represent workplace conditions as closely as possible Acceptable simulation requires:
scope to determine that work is conducted within legislative and regulatory requirements
scope to determine that work is conducted within WHS and infection control requirements
Resources essential for assessment include:
access to relevant workplace or a simulated environment where assessment can take place
instructions on the use of equipment
relevant legislation, regulations and guidelines
relevant manufacturing and packing machinery
weighing and measuring equipment
Method of assessment may include:
Formal appraisal systems
Interviewing and questioning
Observation in the work place
Supporting statement of supervisor(s)
Written assignments/projects
Access and equity considerations:
All workers in the health industry should be aware of access and equity issues in relation to their own area of work
All workers should develop their ability to work in a culturally diverse environment
In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people
Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities
Replaces
| State Code | National Code | Title | Type |
|---|---|---|---|
| D8422 | HLTPH407C | Conduct small-scale compounding of pharmaceutical products | Unit of competency |
Replaced By
| State Code | National Code | Title | Type |
|---|---|---|---|
| AUZ95 | HLTPHA005 | Conduct small scale compounding and labelling of pharmaceutical products | Unit of competency |
| State Code | National Code | Title | Type |
|---|---|---|---|
| J074 | HLT40512 | Certificate IV in Hospital-Health Services Pharmacy Support | Qualification |
| J056 | HLT31412 | Certificate III in Hospital-Health Services Pharmacy Support | Qualification |