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 PampIDs and process flow charting

read and interpret typical test results for inprocess 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 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

FDFOPA Apply principles of statistical process control

FDFOP2015A Apply principles of statistical process control

FDFPHA Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPHA Facilitate and monitor Good Manufacturing Practice

FDFPH4002A Facilitate and monitor Good Manufacturing Practice

FDFPHA Participate in change control procedures

FDFPH4004A Participate in change control procedures

FDFPHA Participate in validation processes

FDFPH4005A Participate in validation processes

MSACMTA Undertake process capability improvements

MSACMT450A Undertake process capability improvements

Guidance information for assessment

To ensure consistency in ones 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

Barriers and control systems

Codes, guidelines and technical standards

Basic microbiology

Sources of technical advice

Storage requirements