Application
This unit of competency describes the skills and knowledge required to comply with relevant Good Manufacturing Practice (GMP) requirements and workplace quality standards in a pharmaceutical manufacturing facility.
The unit applies to individuals who follow GMP requirements to undertake routine pharmaceutical manufacture work, under supervision.
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. Identify requirements of GMP related to own work | 1.1 Locate sources of information on GMP requirements in the workplace 1.2 Identify GMP requirements for pharmaceutical manufacture tasks 1.3 Confirm specific GMP requirements for own work |
2. Prepare for work | 2.1 Ensure personal hygiene meets GMP requirements 2.2 Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures 2.3 Comply with area entry and exit procedures when moving around the workplace |
3. Follow GMP requirements when carrying out work activities | 3.1 Routinely monitor work area, materials and equipment to ensure compliance with GMP requirements 3.2 Handle raw materials, product and packaging components according to GMP requirements and workplace procedures 3.3 Identify contamination and follow appropriate control measures relating to work responsibilities and GMP requirements 3.4 Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures 3.5 Maintain workplace cleanliness and tidiness to meet GMP requirements 3.6 Conduct work according to workplace environmental procedures 3.7 Complete documentation according to workplace procedures |
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 | Identify and comprehend information about GMP requirements |
Writing | Record workplace information using appropriate language and in required format |
Navigate the world of work | Apply workplace procedures to own role and responsibilities Understand main tasks, responsibilities and boundaries of own role |
Interact with others | Report operational and safety information to relevant personnel using required communication method |
Sectors
Pharmaceutical (PHM)