Application
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.
Elements and Performance Criteria
Elements | Performance Criteria |
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. |
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 |
Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential for performance in this unit of competency but are not explicit in the performance criteria.
Skill | Description |
Reading | Interpret key information in GMP requirements and workplace procedures relevant to qualification and validation processes |
Writing | Create qualification procedures and validation reports using relevant technical terminology and format to suit regulatory requirements |
Oral Communication | Demonstrate two-way communication, including active listening and confirming instructions, when explaining qualification processes to team members Use appropriate vocabulary, including technical language to explain processes |
Get the work done | Access and use electronic document management systems |
Sectors
Pharmaceutical (PHM)