Assessor Resource
FDFPH4004A
Participate in change control procedures
Assessment tool
Version 1.0
Issue Date: May 2024
This unit provides an overview of the change management and validation procedures that form part of Good Manufacturing Practice (GMP).
This unit applies to people working in supervisory or line management production/packaging roles. This person would typically work within defined change management and validation programs and procedures. They contribute to the development of these procedures as a team member and are responsible to ensure procedures are supported in the work area.
This unit of competency targets content outlined in Chapter 4 of the Australian Code of Good Manufacturing Practice for Medicinal Products and should be read in conjunction with this document. It covers the skills and knowledge required to participate in change control procedures.
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