This unit of competency describes the skills and knowledge required to setup, operate monitor, adjust and shut down a production process in a pharmaceutical manufacturing facility.

The unit applies to individuals who apply operating principles to the production process. 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.

You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)

List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

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.

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.

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice	Yes	No	Comments/feedback
Confirm incoming goods correspond to workplace documentation
Clean and label containers with prescribed data, according to workplace procedures
Quarantine incoming goods including release and reject status according to Good Manufacturing Practice (GMP) requirements and workplace procedures
Identify and report deviations, unusual events and non-conformances according to GMP and workplace procedures
Confirm equipment and materials meet production requirements
Confirm cleaning requirements and equipment status
Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
Enter processing and operating parameters according to safety and production requirements
Check and adjust equipment performance
Conduct pre-start checks according to workplace procedures
Deliver materials in required quantities and sequence according to batch and production requirements
Record dispensed material, including weight or volume according to batch and production requirements
Label dispensed materials for each batch and stage according to production requirements
Start up, monitor and control production process to maintain process within required limits
Identify and report out of limit products or processes according to workplace procedures
Maintain work area according to workplace cleaning standards
Conduct production process according to safety and environmental requirements
Complete documentation according to workplace procedures
Perform handover according to workplace procedures
Inform handover production team of process and related equipment status at completion of handover
Confirm the workplace procedures for shutting down the process
Complete end-of-batch procedures according to batch instructions and workplace procedures
Safely shut down the process
Complete records according to workplace procedures

Assessment Cover Sheet

FBPPHM3002 - Operate a pharmaceutical production process

Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:

Assessment Record Sheet

FBPPHM3002 - Operate a pharmaceutical production process

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: