Elements and Performance Criteria

This range of variables provides further advice to interpret the scope and context of this unit of competence. It assumes that work is carried out in accordance with relevant organisational policy, legislative requirements, industrial awards and agreements and in-house standard operating procedures (SOPs).

Products include the following:
Formulary drugs and non-formulary drugs, e.g. clinical trial drugs and special access scheme drugs
Products with the required integrity as well as those whose integrity have been compromised, e.g. damaged, contaminated or deteriorated stock
Routine handling products and products requiring special handling, e.g. cytotoxics and its spill management; refrigerated and frozen items, light sensitive materials and flammables

Calculations may be made:
Manually
Using a calculator

Records may be recorded:
Manually
Computer based systems

Records may be produced:
In print form
Electronically

Storage conditions include:
Correct temperature
Humidity
Light
Secured
Ventilated
Ambient
Isolated
Correct storage of hazardous substances
The range of raw materials, manufacturing equipment and packaging devices to be used is specified by the batch/work sheet

Skin cleaning preparations used are specified by hospital/health facility infection control policy and SOPs and may include:
Chlorhexidine gluconate
Povidone iodine preparations
Batch numbers can consist of any combination of numerals and digits as specified in SOP that can uniquely identify an individual product or batch for recording and identification purposes.

Raw materials may include:
Therapeutic agents
Agents considered inactive, that are required for bulking, stabilising, colouring and flavouring the final product

Quarantine period may be defined as time taken to obtain confirmation of suitability of product/batch for human use.

Equipment used in manufacturing process may be disposable or non-disposable and may include:
Balances
Meters
Gauges
Measures
Beakers
Mixers
Pumps
Spatulas
Ointment slabs
Filters
Extractors
Stills
Syringes
Needles
Pestle and mortars

Compounding includes:
Trituration
Aggregation
Grinding
Dissolution
Mixing
Emulsification
Suspension

Product packing may include:
Bulk containers
Patient ready units

Containers include:
Bottles (medicinal and poison)
Glass jars
Tubes
Vials
Syringes
Miscellaneous individual patient unit devices

Labels can be:
Typed
Written
Electronically produced

Cleaning methods include:
Swabbing washing
Sweeping
Wiping
Disinfecting
Soaking
De-scaling

Dosage forms include:
Oral
Parenteral
Topical

Special storage conditions may include:
Refrigeration
Inflammable store

Critical aspects of assessment required include:
Work is carried out in accordance with organisational policy, legislative requirements, industrial awards and agreements and in-house standard operating procedures (SOP's)
Work is performed in a safe manner
Prepare, process and manufacture quality non-sterile pharmaceutical products from fixed formulae
Transport and store product in accordance with GMP
Complete and file documentation correctly
Issues identified outside scope of practice are referred to authorised person

Relationship with other units:
This unit can be delivered and assessed independently, however holistic assessment practice with other pharmacy units of competency is encouraged.

Essential knowledge required includes:
Knowledge of and the rationale for applicable legislation, organisational policy and in-house standard operating procedures (SOPs)
Basic hygiene and the importance of maintaining a clean working environment and equipment
Principles and procedures of maintaining security of pharmaceutical products
Purpose of batch numbering and expiry date on medicines
Identification and handling of products which include:
Formulary drugs and non-formulary drugs, e.g. clinical trial drugs and special access scheme drugs
Products with the required integrity as well as those whose integrity have been compromised, e.g. damaged, contaminated or deteriorated stock
Routine handling products and products requiring special handling, e.g. cytotoxics and its spill management; refrigerated and frozen items, light sensitive materials and flammables
Maintenance principles and procedures of clean work environments
Personal hygiene and clothing standards for manufacturing
Chemical and physical properties of raw materials in relation to formulation and compounding
Principles and procedures of formulae calculations, weights and measures
Purpose of information to be shown on medicine packs, e.g. product name, batch numbering and expiry date
Storage requirements and the rationale for different types of product
Principles of handling and storage of hazardous materials
Sources and types of contamination - microbial, cross-chemical, physical, environmental and corrective strategies
Basic principles of manufacturing processes
Processes for dilution, suspension, incorporation and reconstitution
Nature and use of different dosage forms
Packaging methods, container materials and principles for selection
Principles of record keeping

Underpinning skills:
Produce a product free from microbial or cross-contamination
Assemble, maintain, clean and use all equipment used in manufacturing process in a correct and safe manner and ensure a clean work environment
Select and maintain appropriate equipment for manufacturing task
Calculate drug and non-drug stock requirements
Communicate and interact appropriately with colleagues, health care practitioners, other clients and patients
Use time management strategies to set priorities
Reading and writing skills - literacy competence required to fulfil job roles in a safe manner and as specified by the organisation. The level of skill may range from the ability to understand symbols used in OHS signs, to reading and understanding manufacturer specifications for equipment and good Manufacturing Practice procedures. Written documentation relating to the packing process has to be completed accurately. Literacy support available in the workplace may range from having access to support or assistance from expert/mentor/supervisor, to having no communication supports available. Literacy may be required in English or a community language.
Oral communication skills - language competence required to fulfil job roles in a safe manner and as specified by the organisation. Assessors should look for skills in asking questions, providing clear information, listening to and understanding workplace instructions, and clarifying workplace instructions when necessary. Organisations may require competence in English or a community language, depending on client group.
Numeracy skills may range from the ability to complete arithmetic calculations including percentages, weighing and measuring items to recording and collating data
Problem solving skills required include ability to use available resources

Resource implications
Resource requirements include all the relevant resources commonly provided in the health service setting. Specific tools may include:
Relevant policies (Good Manufacturing Practice Procedures) and procedures manuals, legislation and standards
Organisation's mission statement, strategic and business plan
Other documentation relevant to the work context such as:
Organisational charts
Weighing and measuring equipment
Relevant manufacturing and packaging machinery
Instructions for the use of equipment
Specific instructions for staff

Method of assessment
Assessment may include:
Observation of work performance
Written tasks
Interview and questioning
Authenticated portfolio/log book
Supporting statement of supervisor(s)
Authenticated evidence of relevant work experience and/or formal/informal learning.

Context of assessment:
This unit is most appropriately assessed in the workplace or a simulated workplace environment under the normal range of work conditions.

Assessment should be conducted on more than one occasion to cover a variety of circumstances and to establish consistency.

A diversity of assessment tasks is essential for holistic assessment.