Facilitate and monitor Good Manufacturing Practice

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 FDFPH4002A, 'Facilitate and monitor Good Manufacturing Practice'.
Google Links
links to google searches, with filtering in place to maximise the usefulness of the returned results
Books
Reference books for 'Facilitate and monitor Good Manufacturing Practice' 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

ELEMENT

PERFORMANCE CRITERIA

1. Prepare to meet GMP requirements in the work area

1.1. Regulations, codes and guides relevant to the work area are identified

1.2. Workplace documentation relevant to work area activities is identified and reviewed to confirm that GMP requirements are met

1.3. The required facilities, materials, storage, equipment and personnel are confirmed and available

1.4. Operators who have the required competence to perform production/packaging activities to company and GMP standards are identified

1.5. Line clearance procedures are carried out

1.6. Critical processes are validated according to validation requirements

1.7. Procedures to eliminate or control the risk of cross-contamination are followed

2. Monitor the observance of GMP in the work area

2.1. Work practices conform to GMP requirements

2.2. In-process and environmental monitoring is carried out and recorded as required by GMP

2.3. Personal hygiene and conduct of personnel in the work area meets GMP requirements

2.4. Personnel movement between work areas complies with entry and exit procedures

2.5. GMP-related data is recorded to meet workplace reporting requirements

3. Respond to failures or non-conformances

3.1. The scope of failures or non-conformances are defined

3.2. Procedures to follow in the event of a failure are documented

3.3. Failures are investigated to determine root causes

3.4. Risk assessment is conducted

3.5. Findings are reported to meet GMP requirements

3.6. Procedures are followed to implement and monitor corrective and preventative action

4. Complete work to meet GMP requirements

4.1. Processes are reviewed to ensure all procedures are complete

4.2. Line logs are reviewed to ensure documentation is complete

4.3. End-of-batch procedures are followed


Qualifications and Skillsets

FDFPH4002A appears in the following qualifications:

  • FDF50210 - Diploma of Pharmaceutical Manufacturing
  • FDF40210 - Certificate IV in Pharmaceutical Manufacturing