List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, 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.

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
Locate sources of information relevant to work role from current Australian and other applicable regulatory frameworks for manufacturing pharmaceuticals
Locate sources of information relevant to work role relating to current global harmonisation of GMP compliance and product registrations
Locate sources of information on GMP requirements in the workplace
Identify GMP requirements for pharmaceutical manufacture tasks
Confirm specific GMP requirements for own work
Identify GMP non-compliant situations and risks to product quality
Alert relevant personnel and take appropriate action according to GMP requirements and workplace procedures
Use workplace procedures to identify GMP requirements for documentation
Record information, including calculations and test results according to workplace reporting procedures and GMP requirements
Certify records, including electronic records, according to GMP requirements
Identify information appropriate to work role relating to biosecurity requirements
Follow workplace biosecurity requirements and responsibilities related to work role
Identify common forms of contamination
Conduct work according to workplace environmental procedures
Maintain workplace cleanliness and tidiness to meet GMP requirements
Identify and report signs of unacceptable plant or equipment condition, including calibration status
Identify GMP requirements for routinely monitoring work area, materials, equipment and product
Complete documentation according to workplace procedures
Maintain personal hygiene to meet GMP requirements
Carry out hand washing according to best practice hygiene standards
Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
Comply with area entry and exit procedures when moving around the workplace
Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures
Identify elements of GMP that help improve products and processes
Implement corrective action within level of responsibility

Assessment Cover Sheet

FBPPHM3001 - Apply Good Manufacturing Practice requirements

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

FBPPHM3001 - Apply Good Manufacturing Practice requirements

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: