Elements and Performance Criteria

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. Bold italicised wording, if used in the performance criteria, is detailed below. 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) may also be included.
Barriers and control systems
Barriers and control systems include but are not limited to:
ventilation systems
appropriate clothing
area access restrictions and procedures
cleaning and sanitation procedures
environmental monitoring
line clearance checklists
personal hygiene and conduct
pest prevention
Refer to the Australian Code of Good Manufacturing Practice for Medicinal Products
Codes, guidelines and technical standards
Codes, guidelines and technical standards includes:
the Australian Code of Good Manufacturing Practice for Medicinal Products, Chapter 3 which outlines minimum requirements for design of pharmaceutical production facilities and equipment
Basic microbiology
Basic microbiology covers the ability to source information on:
likely microbiological contaminants given product/packaging used
origins
growth rates
transmission routes
likely carriers
control limits
control methods
Sources of technical advice
Sources of technical advice include but are not limited to:
Therapeutic Goods Administration
British Pharmacopeia
European Pharmacopeia
US Pharmacopeia
Storage requirements
Storage requirements may include but are not limited to:
storage requirements of raw materials prior to use in manufacture
time limits and storage conditions for finished product prior to packaging
other requirements relevant to product range

EVIDENCE GUIDE
The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment
Assessment may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and document management systems related to controlling contamination that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial manufacturing packaging equipment and activities typically used in a commercial manufacturing environment.

Critical aspects for assessment and evidence required to demonstrate competency in this unit
Evidence of ability to:
identify legal, company and audit requirements of contamination control systems and conduct a system review to support audit readiness
demonstrate methods used to monitor consistent observance of contamination control.

Context of and specific resources for assessment
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.
Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects.
Resources for assessment:
copies of the relevant Act, regulations, codes and guides
workplace documentation relating to cleaning and sanitation
real or simulated workplace context.

Method of assessment
This unit could be assessed concurrently with other units of competency relating to problem solving and process improvement. Examples could be:
FDFOP2015A Apply principles of statistical process control
FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice
FDFPH4002A Facilitate and monitor Good Manufacturing Practice
FDFPH4004A Participate in change control procedures
FDFPH4005A Participate in validation processes
MSACMT450A Undertake process capability improvements

Guidance information for assessment
To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.