Google Links

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

Elements and Performance Criteria

  1. Scope the development project
  2. Set scope of project
  3. Develop new product formulation
  4. Assist with preparation of quality/regulatory compliance procedures/materials
  5. Document and report project outcomes

Range Statement

This field allows for different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Standards, codes, procedures and/or workplace requirements

Standards, codes, procedures and/or workplace requirements include the latest version of one or more of:

Australian and international standards covering the requirements for the competence of testing and calibration laboratories, laboratory design and construction, physical containment levels and facility types, laboratory safety, quality and environmental management systems, and measurement management systems

national WHS standards and codes of practice, national measurement regulations and guidelines, and intellectual property (IP) and copyright legislation

Australian and international standards and guidelines covering specialised analysis, accuracy of measurement methods and results, expression of uncertainty, quantifying uncertainty, Association of Analytical Communities International (AOAC International) Official Methods of Analysis, and Validation of Analytical Procedures

specific codes, guidelines, procedures and methods, such as National Association of Testing Authorities (NATA) accreditation programs requirements, Australian code of good manufacturing practice for medicinal products (GMP), principles of good laboratory practice (GLP), Food Standards Australia New Zealand (FSANZ) Code, Australian Dangerous Goods Code, gene technology regulations, National Health and Medical Research Council (NHMRC) Guidelines, and Therapeutic Goods Regulations

workplace documents, such as SOPs; quality and equipment manuals; calibration and maintenance schedules; material safety data sheets (MSDS) and safety procedures; material, production and product specifications; production and laboratory schedules; workplace recording and reporting procedures; waste minimisation and safe disposal procedures; cleaning, hygiene and personal hygiene requirements; stock records and inventory; and raw material catalogues

sampling procedures (labelling, preparation, storage, transport and disposal)

test procedures (validated and authorised)

Product/application briefs

Product/application briefs are provided by, but are not limited to, one or more of:

internal or external customers

marketing

production

Materials used to manufacture products/applications

Materials used to manufacture products/applications include, but are not limited to, one or more of:

solvents

emulsifiers

thickeners

surfactants

disintegrants

fillers

moisturising materials

colouring materials

flavours

perfumes

opacifiers

propellants

sunscreens

Calculations

Calculations are required to adjust properties, such as:

assay/potency

viscosity

application payload

hardness

moisture content

colour

WHS and environmental management requirements

WHS and environmental management requirements include:

· complying with WHS and environmental management requirements at all times, which may be imposed through state/territory or federal legislation. These requirements must not be compromised at any time

· applying standard precautions relating to the potentially hazardous nature of samples

accessing and applying current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health, where relevant

Performance Evidence

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

evaluating at least one (1) product/application brief, preparing the product development plan and contributing significantly to product/application development

interpreting a brief to determine product or application development requirements

interpreting and explaining sections of legislation, codes, regulations and Australian Standards that apply to the tasks undertaken in developing products and applications

applying theoretical knowledge of starting material and formulation principles to develop products or applications

researching alternative formulations and making formulation recommendations for pilot batch manufacture

using environment-friendly strategies for formulations

manufacturing pilot batches

evaluating pilot batches against the project brief

evaluating product or application stability

evaluating the work health and safety (WHS) requirements to be observed for each ingredient during manufacture of product or application

evaluating the WHS suitability of each ingredient for use in the formulation

ensuring that the product or application meets regulatory requirements

documenting the development process in accordance with workplace procedures.

Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

principles of product or application development

business goals and their relationship to specific product or application development

new product/application requirements, expected performance outcomes and key indicators

physical and chemical aspects of new product or application development

details of development plan, budget and timeline for new product/application

principles and practices of operation of pilot batch equipment

uses, characteristics and limitations of formulation starting materials

formulation development procedures

details of regulatory compliance, quality and stability testing protocols and procedures required for new product/application

relevant hazards, WHS and environment requirements.