Unit of competency Outline

Date retreived
23/07/2026 11:59 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 of pharmaceutical products

Conduct small-scale compounding of pharmaceutical products

Unit of competency
National Code
HLTPH407C
State Code
D8422
TGA Status
Replaced
DTWD Status
Replaced
Current Release Number
1.00
Current Release Date
25/03/2011
View on TGA
State Implementation and Classification
Approved Date
01/08/2011
Field of Education
060501 - Pharmacy
Original Release Date
01/08/2011
Nominal Hours
50
Description
DescriptorThis 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
1. Prepare for production process
  • 1.1 Follow correct dress code, safety and personal hygiene procedures
  • 1.2 Maintain preparation areas at NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals requirements
  • 1.3 Clean work area and equipment correctly
  • 1.4 Maintain inventory levels of raw materials and disposable equipment
  • 1.5 Obtain and clarify the confirmed and formulated manufacturing order/master batch sheet from pharmacist
  • 1.6 Prepare production work sheet from formulated manufacturing order/master batch sheet
  • 1.7 Interpret manufacture work sheet and assign appropriate product batch number
  • 1.8 Check and set up manufacturing/compounding machinery
  • 1.9 Prepare production work sheet from master batch sheet / formulated manufacturing order
2. Obtain and process raw materials
  • 2.1 Acquire all materials listed on the worksheet according to stock levels and stock requisitioning procedures
  • 2.2 Check raw materials to ensure they have been released from quarantine for use by authorised persons
  • 2.3 Verify raw materials against manufacturing work sheet and record raw material batch numbers
  • 2.4 Weigh and measure raw materials in designated weighing area
  • 2.5 Allocate raw materials to appropriate manufacturing machinery, where applicable
  • 2.6 Obtain appropriate authorisation/checks at designated points
3. Manufacture/compound products
  • 3.1 Comply with NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals and Australian Standards for operator safety when cleaning, setting up work station and transference of all materials
  • 3.2 Allocate approved raw materials to appropriate machinery, where required
  • 3.3 Incorporate raw materials according to batch documentation
  • 3.4 Compound product according to method on work sheet and in compliance with standard operating procedures for any machinery use
  • 3.5 Obtain required authorisation/checks at designated points
  • 3.6 Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications
  • 3.7 Perform checking procedures and inspect finished product for deviations
  • 3.8 Pack product using appropriate packaging devices/machinery as specified on the work sheet, and following approval from an authorised person
  • 3.9 Label containers/units according to labelling specifications on the work sheet
  • 3.10 Pack and label a retention sample and/or quality control sample if specified on the work sheet
4. Complete production process
  • 4.1 Place product in quarantine area under appropriate storage conditions, where specified
  • 4.2 Clean machinery and manufacturing area and dispose of disposable equipment safely
  • 4.3 Complete machinery and equipment records and/or logs
  • 4.4 Complete documentation and forward to appropriate person
  • 4.5 Complete machinery and equipment records and/or logs
  • 4.6 Reconcile the number of labels printed with number used and discard excess, noting and documenting discrepancies in labels
  • 4.7 Complete documentation and forward to an authorised person
  • 4.8 Report all discrepancies to an authorised person
  • 4.9 Obtain final clearance from an authorised person
5. Participate in quality control
  • 5.1 Submit product sample and relevant documentation to quality control, where specified
  • 5.2 Record and file product quality control assay results
6. Store and transport released product
  • 6.1 Store products according to manufacturing documentation
  • 6.2 Obtain released product(s) from quarantine store
  • 6.3 Pack released product(s) into appropriate delivery containers
  • 6.4 Deliver product to store/dispensary/client care area by appropriate means
  • 6.5 Advise receipting area personnel of any special storage requirements
  • 6.6 Complete and file records and/or work sheets
No information
No information
Replaces
State Code National Code Title Type
C9426 HLTPH407B Conduct small-scale compounding of pharmaceutical products Unit of competency
C5106 HLTPH7A Small scale compound/manufacture of pharmaceutical products Unit of competency
Replaced By
State Code National Code Title Type
WD259 HLTPH408A Conduct small scale compounding and labelling of pharmaceutical products Unit of competency
State Code National Code Title Type
D057 HLT40507 Certificate IV in Hospital/Health Services Pharmacy Support Qualification