Unit of competency Outline

Date retreived
22/07/2026 1:22 AM AWST

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Apply Good Manufacturing Practice requirements

Apply Good Manufacturing Practice requirements

Unit of competency
National Code
FBPPHM3020
State Code
ODX76
TGA Status
Current
DTWD Status
Approved
Current Release Number
1.00
Current Release Date
20/04/2022
View on TGA
State Implementation and Classification
Approved Date
08/07/2022
Field of Education
030101 - Manufacturing Engineering
Original Release Date
08/07/2022
Nominal Hours
45
Description
This unit of competency describes the skills and knowledge required to comply with relevant Good Manufacturing Practice (GMP) requirements and workplace quality standards in a pharmaceutical manufacturing facility.The unit applies to individuals who apply GMP requirements to undertake pharmaceutical manufacture work. 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. Identify requirements of GMP related to own work
  • 1.1 Locate sources of information on GMP requirements and regulatory obligations of employees relevant to work role from current Australian and other applicable regulatory frameworks for manufacturing pharmaceuticals
  • 1.2 Identify GMP requirements for pharmaceutical manufacture tasks
  • 1.3 Confirm specific GMP requirements for own work
  • 1.4 Identify GMP non-compliant situations and risks to product quality
  • 1.5 Alert relevant personnel and take appropriate action according to GMP requirements and workplace procedures
2. Complete workplace documentation to support GMP
  • 2.1 Use workplace procedures to identify GMP requirements for documentation
  • 2.2 Record required information, calculations and test results according to workplace reporting procedures and GMP requirements
  • 2.3 Certify records according to GMP requirements
3. Identify and follow biosecurity requirements
  • 3.1 Identify information appropriate to work role relating to biosecurity requirements
  • 3.2 Follow workplace biosecurity requirements and responsibilities related to work role
4. Apply GMP requirements when carrying out work activities
  • 4.1 Identify common forms of contamination relevant to own work activities
  • 4.2 Conduct work according to workplace environmental procedures
  • 4.3 Maintain workplace cleanliness and tidiness to meet GMP requirements
  • 4.4 Identify and report signs of unacceptable plant, equipment condition or calibration status
  • 4.5 Identify GMP requirements for routinely monitoring work area, materials, equipment and product
  • 4.6 Complete documentation according to workplace procedures
5. Apply hygiene and entry and exit procedures to meet GMP requirements
  • 5.1 Maintain personal hygiene to meet GMP requirements
  • 5.2 Carry out hand washing according to best practice hygiene standards
  • 5.3 Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
  • 5.4 Comply with area entry and exit procedures when moving around the workplace
6. Participate in improving GMP
  • 6.1 Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures
  • 6.2 Identify elements of GMP that help improve products and processes
  • 6.3 Implement corrective action within level of responsibility
No information
No information
Replaces
State Code National Code Title Type
OAL95 FBPPHM3001 Apply Good Manufacturing Practice requirements Unit of competency