Unit of competency Outline

Date retreived
22/07/2026 7:04 AM AWST

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Monitor and maintain Good Manufacturing Practice requirements

Monitor and maintain Good Manufacturing Practice requirements

Unit of competency
National Code
FBPPHM4001
State Code
OAM08
TGA Status
Current
DTWD Status
Approved
Current Release Number
2.00
Current Release Date
20/04/2022
View on TGA
State Implementation and Classification
Approved Date
18/04/2019
Field of Education
080317 - Quality Management
Original Release Date
18/04/2019
Nominal Hours
80
Description
This unit of competency describes the skills and knowledge required to provide a leadership role in the day-to-day monitoring and maintenance of Good Manufacturing Practice (GMP) in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of GMP requirements who communicate workplace policies and procedures relevant to pharmaceutical manufacturing operations and have responsibility for the output of others. This includes applying and communicating non-routine technical solutions to predictable and unpredictable problems.No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
1. Empower team members to identify GMP requirements
  • 1.1 Ensure personal protective equipment and contamination prevention clothing used by team members is serviceable and fitted correctly according to work health and safety requirements
  • 1.2 Ensure GMP requirements and workplace procedures are available
  • 1.3 Identify and address training needs according to team member's level of responsibility
  • 1.4 Provide training and coaching to support individuals and groups to implement GMP requirements and related workplace procedures
  • 1.5 Demonstrate personal hygiene to others to support implementation of GMP requirements and workplace procedures
  • 1.6 Monitor and control resource allocation according to workplace procedures and GMP requirements
  • 1.7 Ensure GMP control measures used in the work area are identifiable by workers
2. Monitor personal hygiene and conduct of team members
  • 2.1 Ensure personal hygiene of work team meets GMP requirements
  • 2.2 Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
  • 2.3 Ensure personal movements within workplace comply with area entry and exit procedures
3. Monitor implementation of GMP requirements
  • 3.1 Clearly define, document and follow GMP requirements in work area
  • 3.2 Participate in a root cause analysis (RCA) as part of a cross-functional team and report non-compliance(s) from workplace procedures
  • 3.3 Identify and report GMP non-conformance(s) and signs of unacceptable plant or equipment condition
  • 3.4 Put in place quality approved corrective action or preventative action (CAPA)
  • 3.5 Record information according to workplace reporting procedures and to meet GMP requirements
  • 3.6 Ensure team members maintain work area according to workplace cleaning standards
4. Maintain and facilitate continuous improvement of GMP
  • 4.1 Identify, report and correct processes or conditions which could result in GMP non-conformance according to individual level of responsibility
  • 4.2 Promptly resolve matters relating to GMP or refer them to appropriate personnel
  • 4.3 Monitor effectiveness of CAPA and control measures according to level of responsibility
  • 4.4 Advise others in the work area of GMP matters relevant to their work role
  • 4.5 Maintain workplace records and documents according to workplace procedures and GMP requirements
No information
No information
Replaces
State Code National Code Title Type
D4690 FDFPH3001A Monitor and maintain Good Manufacturing Practice procedures Unit of competency