Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

FDFPH4003A Mapping and Delivery Guide
Facilitate contamination control

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FDFPH4003A - Facilitate contamination control
Description This unit of competency targets content outlined in Chapter 4 of the Australian Code of Good Manufacturing Practice for Medicinal Products and should be read in conjunction with this document. It covers the skills and knowledge required to facilitate contamination control in a work area.
Employability Skills This unit contains employability skills.
Learning Outcomes and Application This unit provides an overview of the cleaning and sanitation systems, equipment and procedures used in a pharmaceutical workplace.This unit applies to people working in supervisory or line management production/packaging roles. This person would typically work within defined cleaning, sanitation, change control and validation programs and procedures. They need to be aware of the systems, equipment and procedures used and are responsible to oversee implementation in their work area.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities 		Slides
PPT 		Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Contamination risks and related control measures are identified and implemented to meet GMP requirements
  • Hazards that could present a contamination risk are identified by type, origin and product association
  • Hazards and related control measures, critical limits, monitoring and recording requirements are reviewed and meet GMP requirements
  • Control measures are verified or validated
       
Element: Review systems and procedures used to control risk of cross contamination
  • Effective barriers and control systems to minimise risk of cross contamination are identified and meet GMP requirements
  • In-process and environmental monitoring occurs and is recorded as required by GMP
  • Cleaning procedures are validated according to validation procedures, roles and responsibilities
  • Line clearance checklists and procedures are followed in the work area
  • Personal hygiene and conduct of personnel in the work area meets GMP requirements
  • Operators have the required skills and knowledge required to support cleaning and sanitation and personal hygiene policies and procedures
       


Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Assessment may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and document management systems related to controlling contamination that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial manufacturing packaging equipment and activities typically used in a commercial manufacturing environment.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of ability to:

identify legal, company and audit requirements of contamination control systems and conduct a system review to support audit readiness

demonstrate methods used to monitor consistent observance of contamination control.

Context of and specific resources for assessment

Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.

Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects.

Resources for assessment:

copies of the relevant Act, regulations, codes and guides

workplace documentation relating to cleaning and sanitation

real or simulated workplace context.

Method of assessment

This unit could be assessed concurrently with other units of competency relating to problem solving and process improvement. Examples could be:

FDFOP2015A Apply principles of statistical process control

FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPH4002A Facilitate and monitor Good Manufacturing Practice

FDFPH4004A Participate in change control procedures

FDFPH4005A Participate in validation processes

MSACMT450A Undertake process capability improvements

Guidance information for assessment

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

Submission Requirements

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)

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.

Required skills

Ability to:

interpret and apply relevant legislation, codes, guidelines and technical standards

use management systems to ensure that procedures are understood and implemented

monitor that data is recorded to meet GMP recording requirements

read and interpret equipment drawings, piping and instrumentation diagrams (P&IDs) and process flow charting

read and interpret typical test results for in-process and environmental monitoring

use communication and document management systems to access and review relevant documents

use communication skills to interpret and complete work information to support operations of work team or area

demonstrate and support cooperative work practices within a culturally diverse workforce

Required knowledge

Knowledge of:

principles of workflow design to minimise risk of contamination

facility and segregation requirements relevant to products produced

Basic microbiology

microbiological limits, monitoring methods and reporting and recording formats and requirements

Sources of technical advice

ventilation system requirements

personal hygiene and clothing requirements including decontamination and laundering

cleaning records and logs

line clearance procedures, roles and responsibilities

equipment status labelling

cleaning requirements and levels related to dedicated production, campaign processing and multiple product processing

Storage requirements

storage requirements of raw materials prior to use in manufacture, time limits and conditions of storage of finished product prior to packaging, and other requirements relevant to product range

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Barriers and control systems

Barriers and control systems include but are not limited to:

ventilation systems

appropriate clothing

area access restrictions and procedures

cleaning and sanitation procedures

environmental monitoring

line clearance checklists

personal hygiene and conduct

pest prevention

Refer to the Australian Code of Good Manufacturing Practice for Medicinal Products

Codes, guidelines and technical standards

Codes, guidelines and technical standards includes:

the Australian Code of Good Manufacturing Practice for Medicinal Products, Chapter 3 which outlines minimum requirements for design of pharmaceutical production facilities and equipment

Basic microbiology

Basic microbiology covers the ability to source information on:

likely microbiological contaminants given product/packaging used

origins

growth rates

transmission routes

likely carriers

control limits

control methods

Sources of technical advice

Sources of technical advice include but are not limited to:

Therapeutic Goods Administration

British Pharmacopeia

European Pharmacopeia

US Pharmacopeia

Storage requirements

Storage requirements may include but are not limited to:

storage requirements of raw materials prior to use in manufacture

time limits and storage conditions for finished product prior to packaging

other requirements relevant to product range

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
Hazards that could present a contamination risk are identified by type, origin and product association 
Hazards and related control measures, critical limits, monitoring and recording requirements are reviewed and meet GMP requirements 
Control measures are verified or validated 
Effective barriers and control systems to minimise risk of cross contamination are identified and meet GMP requirements 
In-process and environmental monitoring occurs and is recorded as required by GMP 
Cleaning procedures are validated according to validation procedures, roles and responsibilities 
Line clearance checklists and procedures are followed in the work area 
Personal hygiene and conduct of personnel in the work area meets GMP requirements 
Operators have the required skills and knowledge required to support cleaning and sanitation and personal hygiene policies and procedures 

Forms

Assessment Cover Sheet

FDFPH4003A - 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

FDFPH4003A - 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: