This unit of competency describes the skills and knowledge required to prepare to enter, work and exit a controlled environment in a pharmaceutical manufacturing facility.

The unit applies to individuals who apply Good Manufacturing Practice (GMP) requirements and operating principles to working in a controlled environment. Individuals work under broad direction and take responsibility for their own work.

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.

This section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Controlled environment must include at least one of the following:	controlled, non-classified environment cleanrooms that are controlled environments that have been certified as meeting an internationally recognised standard.
Contamination prevention clothing must include at least one of the following:	facility suits for controlled, non-classified environment disposable and reusable garments for controlled, classified cleanroom environments.

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
Obtain workplace information, including workplace procedures related to working in a controlled environment
Remove jewellery and makeup according to workplace procedures
Wash hands according to workplace procedures
Source and fit personal protective equipment (PPE) and contamination prevention clothing prior to entering controlled environment
Check controlled environment operating conditions prior to entry
Enter controlled environment according to workplace procedures
Take commodity items into the controlled environment according to workplace procedures
Conduct work activities to minimise risk of contamination
Identify controlled environment contamination risks
Control environmental contamination according to GMP requirements and workplace procedures
Maintain controlled environment work area according to workplace cleaning standards and environmental requirements
Report practices inconsistent with GMP according to workplace procedures
Follow workplace procedures to exit a controlled environment
Remove PPE and contamination prevention clothing according to workplace procedures
De-gown according to workplace procedures
Check, store and dispose of PPE according to manufacturer specifications, environmental and work health and safety requirements

Assessment Cover Sheet

FBPPHM3003 - Work in a controlled environment

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

FBPPHM3003 - Work in a controlled environment

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: