This unit of competency describes the skills and knowledge required to identify and implement contamination control measures in a pharmaceutical manufacturing facility.

The unit applies to individuals with specialised skills and knowledge of Good Manufacturing Practice (GMP) requirements who are responsible for overseeing the implementation of cleaning, sanitation, change control and validation programs within pharmaceutical manufacturing operations and have responsibility for the output of others. This includes applying and communicating non-routine technical solutions to predictable and unpredictable problems.

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
Identify hazards that could present contamination risks by type, origin and product association
Review hazards and risk control measures to confirm they meet GMP requirements
Conduct risk assessment according to GMP requirements and workplace procedures
Confirm control measures
Identify effective barriers and control systems to minimise risk of cross-contamination according to GMP requirements and workplace procedures
Conduct in-process and environmental monitoring according to GMP requirements and workplace procedures
Validate cleaning processes according to workplace procedures
Confirm line clearance procedures
Ensure personal hygiene and conduct of personnel in work area meets GMP requirements
Ensure operators have the skills and knowledge required to apply contamination control measures

Assessment Cover Sheet

FBPPHM4003 - Facilitate contamination control

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

FBPPHM4003 - Facilitate contamination control

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: