Elements

Performance Criteria

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1. Receipt materials and components

1.1 Confirm incoming goods correspond to workplace documentation

1.2 Clean and label containers with prescribed data, according to workplace procedures

1.3 Quarantine incoming goods including release and reject status according to Good Manufacturing Practice (GMP) requirements and workplace procedures

1.4 Identify and report deviations, unusual events and non-conformances according to GMP and workplace procedures

2. Set up the production process for operation

2.1 Confirm equipment and materials meet production requirements

2.2 Confirm cleaning requirements and equipment status

2.3 Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures

2.4 Enter processing and operating parameters according to safety and production requirements

2.5 Check and adjust equipment performance

2.6 Conduct pre-start checks according to workplace procedures

3. Dispense materials

3.1 Deliver materials in required quantities and sequence according to batch and production requirements

3.2 Record dispensed material, including weight or volume according to batch and production requirements

3.3 Label dispensed materials for each batch and stage according to production requirements

4. Operate and monitor the production process

4.1 Start up, monitor and control production process to maintain process within required limits

4.2 Identify and report out of limit products or processes according to workplace procedures

4.3 Maintain work area according to workplace cleaning standards

4.4 Conduct production process according to safety and environmental requirements

4.5 Complete documentation according to workplace procedures

5. Hand over the production process

5.1 Perform handover according to workplace procedures

5.2 Inform handover production team of process and related equipment status at completion of handover

6. Shut down the process

6.1 Confirm the workplace procedures for shutting down the process

6.2 Complete end-of-batch procedures according to batch instructions and workplace procedures

6.3 Safely shut down the process

6.4 Complete records according to workplace procedures

Skill

Description

Reading

Identify relevant information from workplace documentation and interpret requirements for the pharmaceutical production process

Writing

Complete workplace documentation using appropriate language and in required format

Numeracy

Interpret material and product specifications

Navigate the world of work

Identify workplace procedures relevant to own role

Interact with others

Report operational and safety information to relevant personnel using required communication method

Get the work done

Plan, organise and implement tasks required to achieve production outcomes

Use problem-solving skills to analyse product and process faults and decide on appropriate action

Equipment must include:

at least one from the three items below:

bioreactor

tablet press

sterilising equipment

plus all of the following items:

filling machine

filtration equipment

mixing vessel

weighing instrument.

Cleaning requirements must include:

area or line clearance

full or partial clean

automated or semi-automated or manual cleaning of equipment

sanitation or sterilisation.

Equipment status must include:

calibrated

clean

clean/dirty hold time

in use

ready to use.

Pre-start checks must include:

carrying out required area or line clearances

inspecting equipment condition to identify signs of wear

confirming all safety equipment is in place and operational

confirming that equipment is clean or sanitised

confirming that equipment is correctly configured for processing requirements

Items to monitor must include:

environment

product appearance

pH

volume or weight

temperature.