FBPPHM3011
Dispense pharmaceutical raw materials


Application

This unit of competency describes the skills and knowledge required to weigh, measure and label non-bulk ingredients to meet batch requirements in a pharmaceutical manufacturing facility.

The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the dispensing of raw materials. 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 dispense raw materials

1.1 Confirm material status, type, quality clearance and quantities

1.2 Identify, rectify and report contamination or non-compliance issues according to workplace procedures

1.3 Confirm measuring and weighing equipment are available to meet dispensing requirements

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

1.5 Supply containers, bags and labels according to batch and production requirements

1.6 Conduct pre-start checks according to workplace requirements

2. Measure and weigh raw materials

2.1 Weigh and measure non-bulk ingredients and additives according to batch and production requirements

2.2 Monitor accuracy of measuring and dispensing equipment

2.3 Identify and report out of limit equipment operation according to workplace procedures

2.4 Label dispensed ingredients according to batch and production requirements

2.5 Maintain work area according to workplace cleaning standards

2.6 Conduct process according to workplace safety and environmental requirements

3. Shut down the dispensing process

3.1 Confirm the workplace procedures for shutting down the process

3.2 Safely shut down the process

3.3 Clean dispensing equipment according to workplace procedures

3.4 Report unacceptable equipment and utensil condition

3.5 Reconcile dispensed materials

3.6 Complete records 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

Interpret workplace procedures for dispensing pharmaceutical raw materials

Writing

Complete workplace documentation using appropriate language and in required format

Numeracy

Extract and interpret mathematical information embedded in job specifications and stock control data to meet production requirements

Use equipment to measure and weigh materials and additives to meet batch requirements

Check and interpret raw material labels, codes and quantity

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 dispensing outcomes

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


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.

Pre start checksmust include:

inspecting the condition and cleanliness of equipment and shared or dedicated utensils

confirming that equipment is correctly configured for dispensing requirements.


Sectors

Pharmaceutical (PHM)