Unit of competency Outline

Date retreived
22/07/2026 6:38 AM AWST

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Participate in change control procedures

Participate in change control procedures

Unit of competency
National Code
FBPPHM4004
State Code
OAN71
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
080307 - Organisation Management
Original Release Date
18/04/2019
Nominal Hours
60
Description
This unit of competency describes the skills and knowledge required to participate in planning and implementing change control procedures to meet Good Manufacturing Practice (GMP) requirements in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of GMP requirements who contribute to the development of defined change management programs 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. Participate in planning change
  • 1.1 Interpret change proposal to identify impact of change on the workplace
  • 1.2 Interpret workplace procedures and GMP requirements for managing change
  • 1.3 Conduct risk assessment for change implementation in the workplace
  • 1.4 Undertake planning of change management
  • 1.5 Identify workplace procedures affected by change management plan and allocate responsibilities for review
  • 1.6 Identify training needs arising from change and determine delivery methods and responsibilities
  • 1.7 Apply authorisation requirements according to workplace change control procedures
  • 1.8 Finalise change management plan according to workplace procedures and GMP requirements
2. Participate in implementing change
  • 2.1 Communicate change to all affected personnel
  • 2.2 Implement training to support affected individuals and groups according to workplace procedures
  • 2.3 Revise workplace procedures to reflect change requirements
  • 2.4 Monitor and evaluate change according to workplace change control procedures
  • 2.5 Implement adjustments to change according to workplace change control procedures
  • 2.6 Maintain workplace records and documents according to workplace change control procedures and GMP requirements
No information
No information
Replaces
State Code National Code Title Type
D4694 FDFPH4004A Participate in change control procedures Unit of competency