Assessor Resource
FDFPH4005A
Participate in validation processes
Assessment tool
Version 1.0
Issue Date: May 2024
This unit provides an overview of validation processes used to support Good Manufacturing Practice (GMP) in the pharmaceutical sector.
The unit covers the skills and knowledge required by production/packaging line managers or supervisors to participate in validation processes. This person would not typically have responsibility for validation but would require an understanding of the purpose, procedures and responsibilities for different types of validation.
This unit applies to people working in a supervisory or line management role. Their involvement in validation would typically be as part of a multi-disciplinary team.
The unit is targets content outlined in Annex 15 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 validation processes.
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