Unit of competency Outline

Date retreived
22/07/2026 6:48 AM AWST

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Participate in validation of pharmaceutical manufacturing processes

Participate in validation of pharmaceutical manufacturing processes

Unit of competency
National Code
FBPPHM4005
State Code
OAM58
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
40
Description
This unit of competency describes the skills and knowledge required to use qualification and validation processes 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 participate in validation process relevant to pharmaceutical manufacturing operations as part of a multi-disciplinary team 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 qualification processes for facilities, systems or equipment
  • 1.1 Identify procedures for developing and implementing qualification processes
  • 1.2 Develop and review qualification processes and documentation according to workplace procedures
  • 1.3 Implement qualification process training needs
2. Participate in validation processes for facilities, systems or equipment
  • 2.1 Identify validation requirements according to workplace procedures and GMP requirements
  • 2.2 Follow validation protocol to support validation activities in the work area
  • 2.3 Evaluate and document deviations and exceptions from protocol
  • 2.4 Maintain workplace records and documents according to workplace procedures and GMP requirements
No information
No information
Replaces
State Code National Code Title Type
D4695 FDFPH4005A Participate in validation processes Unit of competency