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 FBPPHM3001, 'Apply Good Manufacturing Practice requirements'.
- Google Links
- links to google searches, with filtering in place to maximise the usefulness of the returned results
- Books
- Reference books for 'Apply Good Manufacturing Practice requirements' 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. Identify GMP as a regulatory concept | 1.1 Locate sources of information relevant to work role from current Australian and other applicable regulatory frameworks for manufacturing pharmaceuticals 1.2 Locate sources of information relevant to work role relating to current global harmonisation of GMP compliance and product registrations |
2. Identify requirements of GMP related to own work | 2.1 Locate sources of information on GMP requirements in the workplace 2.2 Identify GMP requirements for pharmaceutical manufacture tasks 2.3 Confirm specific GMP requirements for own work 2.4 Identify GMP non-compliant situations and risks to product quality 2.5 Alert relevant personnel and take appropriate action according to GMP requirements and workplace procedures |
3. Complete workplace documentation to support GMP | 3.1 Use workplace procedures to identify GMP requirements for documentation 3.2 Record information, including calculations and test results according to workplace reporting procedures and GMP requirements 3.3 Certify records, including electronic records, according to GMP requirements |
4. Identify and follow biosecurity requirements | 4.1 Identify information appropriate to work role relating to biosecurity requirements 4.2 Follow workplace biosecurity requirements and responsibilities related to work role |
5. Apply GMP requirements when carrying out work activities | 5.1 Identify common forms of contamination 5.2 Conduct work according to workplace environmental procedures 5.3 Maintain workplace cleanliness and tidiness to meet GMP requirements 5.4 Identify and report signs of unacceptable plant or equipment condition, including calibration status 5.5 Identify GMP requirements for routinely monitoring work area, materials, equipment and product 5.6 Complete documentation according to workplace procedures |
6. Ensure personal hygiene and conduct meet GMP requirements | 6.1 Maintain personal hygiene to meet GMP requirements 6.2 Carry out hand washing according to best practice hygiene standards 6.3 Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures 6.4 Comply with area entry and exit procedures when moving around the workplace |
7. Participate in improving GMP | 7.1 Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures 7.2 Identify elements of GMP that help improve products and processes 7.3 Implement corrective action within level of responsibility |