Operate a pharmaceutical production process

Formats and tools

Unit Description
Reconstruct the unit from the xml and display it as an HTML page.
Assessment Tool
an assessor resource that builds a framework for writing an assessment tool
Assessment Template
generate a spreadsheet for marking this unit in a classroom environment. Put student names in the top row and check them off as they demonstrate competenece for each of the unit's elements and performance criteria.
Assessment Matrix
a slightly different format than the assessment template. A spreadsheet with unit names, elements and performance criteria in separate columns. Put assessment names in column headings to track which performance criteria each one covers. Good for ensuring that you've covered every one of the performance criteria with your assessment instrument (all assessement tools together).
Wiki Markup
mark up the unit in a wiki markup codes, ready to copy and paste into a wiki page. The output will work in most wikis but is designed to work particularly well as a Wikiversity learning project.
Evidence Guide
create an evidence guide for workplace assessment and RPL applicants
Competency Mapping Template
Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners. A template for developing assessments for a unit, which will help you to create valid, fair and reliable assessments for the unit, ready to give to trainers and students
Observation Checklist
create an observation checklist for workplace assessment and RPL applicants. This is similar to the evidence guide above, but a little shorter and friendlier on your printer. You will also need to create a seperate Assessor Marking Guide for guidelines on gathering evidence and a list of key points for each activity observed using the unit's range statement, required skills and evidence required (see the unit's html page for details)

Self Assessment Survey
A form for students to assess thier current skill levels against each of the unit's performance criteria. Cut and paste into a web document or print and distribute in hard copy.
Moodle Outcomes
Create a csv file of the unit's performance criteria to import into a moodle course as outcomes, ready to associate with each of your assignments. Here's a quick 'how to' for importing these into moodle 2.x
Registered Training Organisations
Trying to find someone to train or assess you? This link lists all the RTOs that are currently registered to deliver FBPPHM3002, 'Operate a pharmaceutical production process'.
Google Links
links to google searches, with filtering in place to maximise the usefulness of the returned results
Books
Reference books for 'Operate a pharmaceutical production process' on fishpond.com.au. This online store has a huge range of books, pretty reasonable prices, free delivery in Australia *and* they give a small commission to ntisthis.com for every purchase, so go nuts :)


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. 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