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Evidence Guide: FBPPHM3002 - Operate a pharmaceutical production process

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

FBPPHM3002 - Operate a pharmaceutical production process

What evidence can you provide to prove your understanding of each of the following citeria?

Receipt materials and components

  1. Confirm incoming goods correspond to workplace documentation
  2. Clean and label containers with prescribed data, according to workplace procedures
  3. Quarantine incoming goods including release and reject status according to Good Manufacturing Practice (GMP) requirements and workplace procedures
  4. Identify and report deviations, unusual events and non-conformances according to GMP and workplace procedures
Confirm incoming goods correspond to workplace documentation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Set up the production process for operation

  1. Confirm equipment and materials meet production requirements
  2. Confirm cleaning requirements and equipment status
  3. Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
  4. Enter processing and operating parameters according to safety and production requirements
  5. Check and adjust equipment performance
  6. Conduct pre-start checks according to workplace procedures
Confirm equipment and materials meet production requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm cleaning requirements and equipment status

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Enter processing and operating parameters according to safety and production requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check and adjust equipment performance

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct pre-start checks according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Dispense materials

  1. Deliver materials in required quantities and sequence according to batch and production requirements
  2. Record dispensed material, including weight or volume according to batch and production requirements
  3. Label dispensed materials for each batch and stage according to production requirements
Deliver materials in required quantities and sequence according to batch and production requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Operate and monitor the production process

  1. Start up, monitor and control production process to maintain process within required limits
  2. Identify and report out of limit products or processes according to workplace procedures
  3. Maintain work area according to workplace cleaning standards
  4. Conduct production process according to safety and environmental requirements
  5. Complete documentation according to workplace procedures
Start up, monitor and control production process to maintain process within required limits

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain work area according to workplace cleaning standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct production process according to safety and environmental requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete documentation according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Hand over the production process

  1. Perform handover according to workplace procedures
  2. Inform handover production team of process and related equipment status at completion of handover
Perform handover according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down the process

  1. Confirm the workplace procedures for shutting down the process
  2. Complete end-of-batch procedures according to batch instructions and workplace procedures
  3. Safely shut down the process
  4. Complete records according to workplace procedures
Confirm the workplace procedures for shutting down the process

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Safely shut down the process

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete records according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge
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.

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.