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.
Regulations, codes and guides
Relevant regulations, codes and guides include:
Therapeutic Goods Act
Therapeutic Goods Regulations
Australian Code of Good Manufacturing Practice for Medicinal Products
Therapeutic Goods Act guides to interpretation of legal requirements
regulations, codes and guides related to other relevant international legislation (appropriate to product and market)
company policies and guidelines
Change
Change that must be controlled refers to any change that may affect product quality or reproducibility of the process. This may include but is not limited to change in:
formulation
product component
method of production or testing
process environment (or site)
batch size
equipment
Change management
Change management procedures and data requirements must meet the requirements of Change Management as outlined in Annex 15 of the Australian Code of Good Manufacturing Practice for Medicinal Products
Workplace documentation
Workplace documentation relevant to work area activities includes:
company policies and procedures
specifications
manufacturing formulae
processing and packaging instructions
scaling batch size up or down
batch production and packaging records
standard operating procedures (SOPs)
operating manuals
OHS information, including material safety data sheets (MSDS)
Authorisation requirements
Authorisation requirements reflect regulatory requirements and internal authorisation processes
Change management plan
A change management plan includes steps or activities required to approve and implement the proposed change. Typically these steps will be described in a change control SOP. Depending on the significance/level of the change, this could include:
process capability assessment
test methods
validation
liaison with regulator
It also includes:
timelines
responsibilities, including sign-off/approval
verification of the effectiveness of change
OHS implications

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 change control 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 participation in a project team to control change in a work area. This includes providing evidence that the candidate:
identifies situations requiring change control for a given set of change scenarios
participates in developing a change management plan
develops a documented implementation plan to introduce change into a work area. This may be a sub-set of a larger change management plan
leads the implementation of change in a work area. This includes reviewing relevant workplace documentation, ensuring that required training occurs, consulting with parties affected by change and negotiating any issues raised, monitoring and reporting on change and liaising with relevant departments/ personnel to ensure that authorisation and validation processes occur as required.

Context of and specific resources for assessment
Resources for assessment
change request
workplace documentation including procedures relating to change control
real or simulated workplace context.

Method of assessment
This unit could be assessed concurrently with other units 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
FDFPH4003A Facilitate contamination control
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.