Application
This unit of competency describes the skills and knowledge required to prepare to enter, work and exit a controlled environment in a pharmaceutical manufacturing facility.
The unit applies to individuals who apply Good Manufacturing Practice (GMP) requirements and operating principles to working in a controlled environment. Individuals work under broad direction and take responsibility for their own work.
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. Prepare to enter a controlled environment | 1.1 Obtain workplace information, including workplace procedures related to working in a controlled environment 1.2 Remove jewellery and makeup according to workplace procedures 1.3 Wash hands according to workplace procedures 1.4 Source and fit personal protective equipment (PPE) and contamination prevention clothing prior to entering controlled environment 1.5 Check controlled environment operating conditions prior to entry |
2. Work in a controlled environment | 2.1 Enter controlled environment according to workplace procedures 2.2 Take commodity items into the controlled environment according to workplace procedures 2.3 Conduct work activities to minimise risk of contamination |
3. Maintain a controlled environment | 3.1 Identify controlled environment contamination risks 3.2 Control environmental contamination according to GMP requirements and workplace procedures 3.3 Maintain controlled environment work area according to workplace cleaning standards and environmental requirements 3.4 Report practices inconsistent with GMP according to workplace procedures |
4. Exit a controlled environment | 4.1 Follow workplace procedures to exit a controlled environment 4.2 Remove PPE and contamination prevention clothing according to workplace procedures 4.3 De-gown according to workplace procedures 4.4 Check, store and dispose of PPE according to manufacturer specifications, environmental and work health and safety 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 signs, symbols, checklists, production schedules, cleaning schedules and other technical information relevant to working in controlled environments Access and interpret GMP information relevant to working in controlled environments |
Writing | Complete workplace documentation using appropriate language and in required format |
Interact with others | Report GMP concerns to relevant personnel using required communication method |
Navigate the world of work | Recognise and follow workplace requirements, including safety requirements and GMP, associated with own role and area of responsibility |
Range Statement
This section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.
Controlled environment must include at least one of the following: | controlled, non-classified environment cleanrooms that are controlled environments that have been certified as meeting an internationally recognised standard. |
Contamination prevention clothing must include at least one of the following: | facility suits for controlled, non-classified environment disposable and reusable garments for controlled, classified cleanroom environments. |
Sectors
Pharmaceutical (PHM)