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.
Workplace documentation
Workplace documentation may include but is not limited to:
policies and master plans
quality manual
specifications
certificates
manufacturing formula
processing and packaging instructions
procedures
records
protocols (validation)
reports
Documentation typically includes:
written descriptions
graphic display of information, including diagrams and photos
flow charts
Information is typically stored and accessed electronically
Procedures and records
Information covered by procedures includes but is not limited to:
receipt of starting and packaging material
sampling
testing
release and rejection procedures
validation
equipment assembly and calibration
maintenance, cleaning and sanitation
personnel matters, including training and personal hygiene
environmental monitoring
pest control
complaints
recalls
returns
equipment operation
Records should include but are not limited to:
batch records
equipment recording (as appropriate)
validations
calibrations
maintenance
cleaning or repair work, including details of when/who
operating log sheets
complaints
Stakeholders
Stakeholders refer to process and technical experts and may include but are not limited to:
operators
engineering department
quality assurance
area managers
related functions/personnel
Version control
Version control includes:
the maintenance of workplace documents to meet company and regulatory requirements

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 related document control and management systems 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:
review workplace documentation to confirm that it meets GMP requirements. Documentation may relate to a specific work area (rather than the whole plant). The candidate is required to document their findings
develop, design or amend documentation to support GMP. For example, this could require the development of operating procedures. It may include reviewing and updating existing documentation or developing new documentation within required formats. The candidate must demonstrate application of document control procedures to submit or amend documents. They must also demonstrate that appropriate consultation was undertaken in the development process and the document changes are effectively communicated. This includes demonstrating an awareness of the link to related documents. Where training needs arise from the change, these must be identified together with recommendations for how they can be addressed
review completed GMP-related documents and records to ensure that GMP requirements are met.

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 include:
Australian Code of Good Manufacturing Practice for Medicinal Products
workplace documentation and related document control and management system
workplace personnel
real or simulated workplace context.

Method of assessment
This unit is a core requirement for all pharmaceutical operators at AQF 4 and 5. This unit could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:
FDFPH4002A Facilitate and monitor Good Manufacturing Practice
FDFPH4004A Participate in change control procedures
FDFPH4005A Participate in validation processes.

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.