Unit of competency Outline

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

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Prepare and review workplace documentation to support Good Manufacturing Practice requirements

Prepare and review workplace documentation to support Good Manufacturing Practice requirements

Unit of competency
National Code
FBPPHM4002
State Code
OAO17
TGA Status
Current
DTWD Status
Approved
Current Release Number
1.00
Current Release Date
18/12/2018
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
60
Description
This unit of competency describes the skills and knowledge required to develop, review and communicate workplace operations documentation to support Good Manufacturing Practice (GMP) in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of GMP requirements who manage and maintain documentation 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. Review and draft workplace documentation to meet GMP requirements
  • 1.1 Identify workplace documentation requiring development or review according to workplace documentation management process and GMP requirements
  • 1.2 Initiate documentation changes according to change control process
  • 1.3 Review workplace documentation in consultation with relevant stakeholders to support GMP
  • 1.4 Draft workplace documentation in consultation with relevant stakeholders to support GMP
  • 1.5 Ensure workplace documentation explains complex information in a simple and clear manner
2. Finalise workplace documentation to meet GMP requirements
  • 2.1 Complete final version of documentation according to documentation management process
  • 2.2 Submit final version of documentation for approval according to change control process
No information
No information
Replaces
State Code National Code Title Type
D4691 FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice Unit of competency