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Follow the links below to find material targeted to the unit's elements, performance criteria, required skills and knowledge

Elements and Performance Criteria

1. Elements define the essential outcomes
2. Source informationon formula
   • Select appropriate formula and master batch sheet for product, based on correct interpretation of the medication order or prescription
   • Confirm suitability of chosen master work sheet and availability of resources
   • Obtain authority of pharmacist to proceed
3. Prepare for production process
   • Comply with dress code, safety and personal hygiene procedures prior to entering the work area
   • Clean work area and equipment correctly
   • Confirm inventory levels of raw materials and disposable equipment
   • Prepare a work sheet referenced from amaster work sheet
   • Verify that batch/work sheets are clearly written in logical order with clear directions and contains all the required information
   • Assign product batch number
   • Generate the product labels referenced from the master label detailed on the master work sheet
   • Check and note the number of labels generated
   • Submit work sheet and labels to pharmacist for approval
   • Check and set up compounding requirements and equipment
4. Obtain equipment and supplies
   • Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures
   • Check raw materials to ensure they have been released from quarantine for use by authorised persons
   • Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates
   • Weigh or measure raw materials in designated area
   • Obtain required authorisation or checks at designated points according to work sheet
5. Compound products
   • Allocate approved raw materials to equipment according to batch work sheet
   • Compound product according to method on work sheet
   • Monitor and adjust compounding to comply with work sheet specifications
   • Perform verification procedures, inspect finished product for deviations and report to authorised person
   • Pack compounded product as specified on the work sheet, and following approval from an authorised person
   • Label containers/units according to labelling specifications on the work sheet
   • Obtain required authorisation or checks at designated points
6. Complete production process
   • Reconcile number of labels printed with number used and report discrepancies to the pharmacist
   • Place product in quarantinearea under appropriate storage conditions
   • Clean machinery and manufacturing area and dispose of disposable equipment safely
   • Complete all required documentation and forward to an authorised person
   • Report all discrepancies to an authorised person
   • Obtain final approval from the pharmacist before releasing packed medicines to storage areas
7. Participate in quality control
   • Pack and label a retention sample and/or quality control sample if specified on the work sheet
   • Submit product sample and relevant documentation to quality control, where specified
   • Record and file product quality control assay results
8. Store and transport released product
   • Store products according to work sheet documentation
   • Obtain released product(s) from quarantine store
   • Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product
   • Deliver product to destination
   • Advise receipting area personnel of specific storage requirements
   • Complete and file records and/or work sheets

Performance Evidence

The candidate must show evidence of the ability to complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the job role. There must be evidence that the candidate has:

followed 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)

identified issues outside scope of own practice and referred to the authorised person

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Knowledge Evidence

The candidate must be able to demonstrate essential knowledge required to effectively complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the work role. This includes knowledge of:

legal and ethical requirements (national, state/territory) for pharmacy work, and how these are applied in organisations, including:

codes of conduct

duty of care (and implications of negligence)

privacy, confidentiality and disclosure

records management

rights and responsibilities of workers, employers and clients

specific legislation:

medicines and their use

the practice of pharmacy

different schedules of medicines and pharmaceutical products

work role boundaries – responsibilities and limitations in manufacturing products

work health and safety

key information in standard pharmaceutical references and their use in manufacturing, including:

APF

MIMs

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 medicines and non-formulary medicines

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 (microbial, cross-chemical, physical, environmental; and corrective strategies)

manufacturing 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 manufacturing:

product security

handling and storage of hazardous materials

quarantine periods

requirements for formulated manufacturing 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

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