Assessor Resource
FBPPHM4004
Participate in change control procedures
Assessment tool
Version 1.0
Issue Date: May 2024
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.
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