HLTPHA014 — Conduct small-scale compounding and labelling of pharmaceutical products

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What an assessment for HLTPHA014 must cover

109 assessable components: 7 elements (40 performance criteria), 4 performance evidence and 65 knowledge evidence requirements. An audit-defensible tool maps every question and task back to these — that mapping is the coverage matrix Auditori generates alongside the assessment.

Elements & performance criteria

1 Source information on formula.

1.1Interpret medication orders and prescriptions to select formula and master batch sheet for product.
1.2Confirm suitability of chosen master work sheet and availability of resources.
1.3Obtain approval from an authorised person to proceed.

2 Prepare for production process.

2.1Comply with personal protection equipment (PPE), safety and personal hygiene procedures prior to entering the work area.
2.2Clean work area and equipment correctly.
2.3Confirm inventory levels of raw materials and disposable equipment.
2.4Prepare a work sheet referenced from a master work sheet.
2.5Verify that batch or work sheets are clearly written in logical order with clear directions and containing all the required information.
2.6Assign product batch number.
2.7Generate the product labels referenced from the master label detailed on the master work sheet.
2.8Check and note the number of labels generated.
2.9Submit work sheet and labels to an authorised person for approval.
2.10Check and set up compounding requirements and equipment.

3 Obtain equipment and supplies.

3.1Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures.
3.2Check raw materials to ensure they have been released from quarantine for use by authorised persons.
3.3Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates.
3.4Weigh or measure raw materials in designated area.
3.5Obtain required authorisation or checks at designated points according to work sheet.

4 Compound products.

4.1Allocate approved raw materials to equipment according to batch work sheet.
4.2Compound product according to method on work sheet.
4.3Monitor and adjust compounding to comply with work sheet specifications.
4.4Perform verification procedures, inspect finished product for deviations and report to an authorised person.
4.5Pack compounded product as specified on the work sheet and following approval from an authorised person.
4.6Label containers or units according to labelling specifications on the work sheet.
4.7Obtain required authorisation or checks at designated points.

5 Complete production process.

5.1Reconcile number of labels printed with number used and report discrepancies to an authorised person.
5.2Place product in quarantine area under appropriate storage conditions.
5.3Clean equipment and compounding area and dispose of disposable equipment safely.
5.4Complete all required documentation and forward to an authorised person.
5.5Report all discrepancies to an authorised person.
5.6Obtain final approval from an authorised person before releasing packed medication to storage areas.

6 Participate in quality control.

6.1Pack and label a retention sample or quality control sample if specified on the work sheet.
6.2Submit product sample and relevant documentation to quality control, where specified.
6.3Record and file product quality control assay results.

7 Store and transport released products.

7.1Store products according to work sheet documentation.
7.2Obtain released products from quarantine store.
7.3Pack released products into delivery containers which will maintain the required ambient conditions for the product.
7.4Deliver product to destination.
7.5Advise receipting area personnel of specific storage requirements.
7.6Complete and file records or work sheets.

Performance evidence

follow workplace procedures and industry codes to correctly and safely compound and label at least 5 different batches of pharmaceutical products listed in the Australian Pharmaceutical Formulary and Handbook (APF)
interpret standard pharmaceutical references
identify issues outside scope of own practice and refer to an authorised person
perform the activities outlined in the performance criteria of this unit during a period of at least 240 hours of work related to hospital or health services pharmacy support in a clinical workplace environment. These 240 hours may be applied collectively across all units of competency that include the requirement for workplace hours for the purposes of assessment.

Knowledge evidence

National, State or Territory legal and ethical requirements for pharmacy work, and how these are applied in organisations, including:
codes of conduct
personal protection equipment (PPE)
duty of care and implications of negligence
privacy, confidentiality and disclosure
records management
rights and responsibilities of workers, employers and patients
specific legislation:
medication and their use
the practice of pharmacy
different schedules of medication and pharmaceutical products
work role boundaries including responsibilities and limitations in compounding products
work health and safety
key information in standard pharmaceutical references and their use in compounding, including:
Australian Pharmaceutical Formulary Handbook (APF)
Monthly Index of Medical Specialities (MIMS) or AusDI Advanced
Australian Medicines Handbook (AMH)
Micromedex
rationale for, and key features of:
The Society of Hospital Pharmacists (SHPA) Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
product identification and handling, including those for:
formulary medication and non-formulary medication
products with the required integrity as well as those whose integrity has been compromised
routine of handling products and products requiring special handling
nature and use of different dosage forms including:
oral
parenteral products
topical
infection control requirements for small scale compounding of pharmaceutical products, including:
correct disposal of sharps and residues
cleaning and disinfection processes
personal hygiene
sources and types of contamination and required responses including microbial, cross-chemical, physical, environmental and corrective strategies
compounding processes relating to small scale compounding, including:
nature and use of oral and topical dosage forms
chemical and physical properties of raw materials in relation to formulation and compounding
types of equipment, their key features and use
compounding of a product according to a work sheet
principles and procedures of formulae calculations, weights and measures
processes for dilution, suspension, incorporation and reconstitution
risk considerations and procedures for pharmaceutical compounding:
product security
handling and storage of hazardous materials
quarantine periods
requirements for formulated compounding documentation
different documentation types, their scope and purpose
worksheet processes
information quality requirements including clarity, logic and completeness
labelling requirements for compounded products, including:
adherence to legislative requirements
name, form and strength of product
ancillary labels as part of label details
hazard warnings
spacing for entry of batch numbers and expiry dates
packaging methods, container materials and principles for selection
storage and transport requirements and rationale for different types of product including:
hazardous materials
special storage considerations:
humidity
isolation
light
temperature
ventilation
features and use of pharmacy systems used for small scale compounding.

Unit content sourced from training.gov.au — © Commonwealth of Australia, licensed under CC BY 4.0. Auditori is not affiliated with the Department of Employment and Workplace Relations.

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Questions about assessing HLTPHA014

What does an assessment tool for HLTPHA014 need to cover?

To satisfy the Principles of Assessment and Rules of Evidence, an assessment for HLTPHA014 needs to address all 109 unit components: 7 elements with 40 performance criteria, 4 performance evidence requirements, 65 knowledge evidence requirements, and the foundation skills. A coverage matrix mapping each question and task to these components is what an auditor looks for.

How does Auditori generate an assessment tool for HLTPHA014?

Auditori pulls the current release of HLTPHA014 from training.gov.au and generates a complete package: candidate assessment, assessor guide with model answers and observation criteria, and a coverage matrix mapping every component. A suitably qualified person then reviews and approves the draft in a built-in workflow — consistent with ASQA's guidance on AI use in VET — before export as branded PDF and editable Word.

Is the first assessment tool really free?

Yes. Every new account includes one free credit — enough to generate the complete assessment tool for HLTPHA014 — with no card and no subscription required. After that it's pay-as-you-go per unit.

Can I check my existing HLTPHA014 assessment instead of generating a new one?

Yes — upload your existing assessment or learner guide and Auditori maps it against every element, performance criterion, PE and KE of HLTPHA014, showing exactly what's covered and what's missing. Mapping costs a quarter of a credit.

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