Elements and Performance Criteria

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
TGA 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


Workplace documentation
Workplace documentation relevant to work area activities includes
company policies and guidelines
specifications
manufacturing formulae
processing and packaging instructions
batch production and packaging records
Standard Operating Procedures (SOPs)
OHS information including Material Safety Data Sheets (MSDS)


Work practices
Work is carried out according to:
company policies and procedures
legislative and licensing requirements. This includes therapeutic good legislation, weights and measures and legislation relating to OHS, environmental management, equal opportunity and affirmative action, industrial awards and agreements


Sources of technical advice
Sources of technical advice include but are not limited to:
Therapeutic Goods Administration
British Pharmacopeia
European Pharmacopeia
US Pharmacopeia


Systems, programs and procedures to support GMP
This includes but is not limited to:
line clearance
cleaning and sanitation
process control
control of cross-contamination
failure investigation
change control
validation
record keeping and documentation management
release for sale
internal audits

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 GMP that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial production/packaging equipment and activities typically used in a commercial manufacturing environment.

Resources for assessment
Copies of the relevant Act, regulations, codes and guides.
Workplace documentation relating to GMP.
Real or simulated workplace context.

Overlap with related units

This unit is a core requirement for all pharmaceutical operators at AQF 4 and 5. It could be assessed concurrently with other units relating to problem solving and process improvement. This may include:

FDFPHFCC4A Facilitate contamination control
FDFPHCCP4A Participate in change control procedures
FDFPHVP4A Participate in validation processes
FDFPHRWD4A Prepare and review workplace documentation to support GMP
MCMT450A Undertake process capability improvements
FDFOPTSPC2A Apply principles of statistical process control

Method of assessment
Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of participation in a project team to develop or review systems and procedures to support GMP in a work area. This includes providing evidence that the candidate:

Provides documented evidence through use of workplace documentation and records to show that the work preparation, processing and completion meet GMP requirements.
Leads response to a failure or non-conformance in the work area. This must include conducting risk assessment, analysing root cause analysis, identifying corrective and preventive action and monitoring implementation. This aspect of assessment may be undertaken as part of a team.

Communicating ideas and information
(0)

Collecting analysing and organising information
(0)

Planning and organising activities
(0)

Working with others and in teams
(0)

Using mathematical ideas and techniques
(0)

Solving problems
(0)

Using technology
(0)