Unit of competency Outline

Date retreived
22/07/2026 6:27 AM AWST

Whilst all efforts are made to provide accurate and timely information from the relevant source/documentation, please be aware that the information supplied may not be the most current version. The accuracy of the detail has not been confirmed by the Department and therefore should not be relied upon without first confirming the contents.

Operate a pharmaceutical production process

Operate a pharmaceutical production process

Unit of competency
National Code
FBPPHM3002
State Code
OAN86
TGA Status
Replaced
DTWD Status
Replaced
Current Release Number
2.00
Current Release Date
25/09/2020
View on TGA
State Implementation and Classification
Approved Date
18/04/2019
Field of Education
030399 - Process And Resources Engineering, N.e.c.
Original Release Date
18/04/2019
Nominal Hours
45
Description
This unit of competency describes the skills and knowledge required to setup, operate monitor, adjust and shut down a production process in a pharmaceutical manufacturing facility.The unit applies to individuals who apply operating principles to the production process. Individuals work under broad direction and take responsibility for their own work.No licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
1. Receipt materials and components
  • 1.1 Confirm incoming goods correspond to workplace documentation
  • 1.2 Clean and label containers with prescribed data, according to workplace procedures
  • 1.3 Quarantine incoming goods including release and reject status according to Good Manufacturing Practice (GMP) requirements and workplace procedures
  • 1.4 Identify and report deviations, unusual events and non-conformances according to GMP and workplace procedures
2. Set up the production process for operation
  • 2.1 Confirm equipment and materialsmeet production requirements
  • 2.2 Confirm cleaning requirements and equipment status
  • 2.3 Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
  • 2.4 Enter processing and operating parameters according to safety and production requirements
  • 2.5 Check and adjust equipment performance
  • 2.6 Conduct pre-start checks according to workplace procedures
3. Dispense materials
  • 3.1 Delivermaterials in required quantities and sequence according to batch and production requirements
  • 3.2 Record dispensed material, including weight or volume according to batch and production requirements
  • 3.3 Label dispensed materials for each batch and stage according to production requirements
4. Operate and monitor the production process
  • 4.1 Start up, monitor and control production process to maintain process within required limits
  • 4.2 Identify and report out of limit products or processes according to workplace procedures
  • 4.3 Maintain work area according to workplace cleaning standards
  • 4.4 Conduct production process according to safety and environmental requirements
  • 4.5 Complete documentation according to workplace procedures
5. Hand over the production process
  • 5.1 Perform handover according to workplace procedures
  • 5.2 Inform handover production team of process and related equipment status at completion of handover
6. Shut down the process
  • 6.1 Confirm the workplace procedures for shutting down the process
  • 6.2 Complete end-of-batch procedures according to batch instructions and workplace procedures
  • 6.3 Safely shut down the process
  • 6.4 Complete records according to workplace procedures
No information
No information
Replaced By
State Code National Code Title Type
ODX75 FBPPHM3021 Operate a pharmaceutical production process Unit of competency