This unit of competency describes the skills and knowledge required to comply with relevant Good Manufacturing Practice (GMP) requirements and workplace quality standards in a pharmaceutical manufacturing facility.

The unit applies to individuals who follow GMP requirements to undertake routine pharmaceutical manufacture work, under supervision.

No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.

You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)

List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, 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 on GMP requirements in the workplace
Identify GMP requirements for pharmaceutical manufacture tasks
Confirm specific GMP requirements for own work
Ensure personal hygiene meets GMP requirements
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
Routinely monitor work area, materials and equipment to ensure compliance with GMP requirements
Handle raw materials, product and packaging components according to GMP requirements and workplace procedures
Identify contamination and follow appropriate control measures relating to work responsibilities and GMP requirements
Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures
Maintain workplace cleanliness and tidiness to meet GMP requirements
Conduct work according to workplace environmental procedures
Complete documentation according to workplace procedures

Assessment Cover Sheet

FBPPHM2001 - Follow work procedures to maintain 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

FBPPHM2001 - Follow work procedures to maintain 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: