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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. Source information on formula
  2. Design master batch/work sheet and labels
  3. Seek approval and release of batch/work sheets for use

Required Skills

This describes the essential skills and knowledge and their level required for this unit

Essential knowledge

The candidate must be able to demonstrate essential knowledge required to effectively do the task outlined in elements and performance criteria of this unit manage the task and manage contingencies in the context of the identified work role

This includes knowledge of

Basic hygiene and the importance of maintaining a clean working environment and equipment

Formulation resources

Hospital or health facility inhouse computer system

Infection control policies guidelines and symbols and their relevance to working in a hospital pharmacy

Identification and handling of products including

formulary drugs and nonformulary drugs eg clinical trial drugs and special access scheme drugs

products with the required integrity as well as those whose integrity has been compromised eg damaged contaminated or deteriorated stock

routine handling of products and products requiring special handling eg cytotoxics and its spill management refrigerated and frozen items light sensitive materials and flammables

Issues of pharmaceutical procedures relevant to formulation and calculation

Knowledge of and the rationale for applicable legislation organisation policy and inhouse standard operating procedures SOPs relating to preparing batch and extemporaneous master work sheets and labels

Knowledge of and the rationale for applicable legislation, organisation policy and
in-house standard operating procedures (SOPs), relating to preparing batch and extemporaneous master work sheets and labels

Nature and usage of different drug dosage forms

OHS policies guidelines and symbols and their relevance to working in a hospital pharmacy

Principles and procedures of maintaining security of pharmaceutical products

Principles and procedures of stock control and maintenance

Principles of good manufacturing practice as per NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals

Principles of mathematics in relation to formulation calculations

Purpose of batch numbering and expiry date on medicines

Storage requirements and rationale for different types of product

Essential skills

It is critical that the candidate demonstrate the ability to

Design master batchwork sheet and labels to meet organisation and legislative requirements

File master and copied documents according to organisation requirements

Refer issues identified outside scope of practice to an authorised person

Work in a safe manner

Work in accordance with relevant organisation policy legislative requirements industrial awards and agreements and inhouse operating procedures SOPs

In addition the candidate must be able to effectively do the task outlined in elements and performance criteria of this unit manage the task and manage contingencies in the context of the identified work role

This includes the ability to

Enter and access data on pharmacy computer system

Take into account opportunities to address waste minimisation environmental responsibility and sustainable practice issues

Use available resources and prioritise workload

Use formulation resources to prepare a master batch sheet

Use literacy numeracy and oral communication skills required to fulfil the position in a safe manner as specified by the health care facility

Use problem solving skills

Use validated formulation resources to formulate a stable pharmaceutically correct quality product

Evidence Required

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 essential 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

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 OHS and infection control requirements

Resources essential for assessment include

Access to relevant workplace or appropriately simulated environment where assessment can take place

Relevant legislation regulations and guidelines

Documentsreferences on pharmaceutical formulations

Instructions on the use of equipment

Method of assessment may include

Observation in the work place if possible

Written assignmentsprojects

Interviewing and questioning

Formal appraisal systems

Supporting statement of supervisors

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 andor Torres Strait Islander clients and communities


Range Statement

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:

Raw drug materials list

Equipment required

Preparation instructions

Storage and stability data

Packaging and label requirements

Master batch/work sheets must:

Be clearly written

Be in logical order

Contain all required information

Contain no ambiguous directions

Master label must:

Be within legislative requirements

Contain name, form and strength of product

Provide spacing for entry of batch numbers and expiry dates

Include hazard warnings

Include ancillary labels as part of label details