Required skills

Ability to

communicate information on GMP requirements to others in the work area including demonstration of twoway communication such as active listening and constructive response to feedback

access and use document management systems

model personal conduct and work activities to meet requirements of GMP

monitor that data is recorded to meet GMP recording requirements within level of responsibility

provide guidance and support to others to in the work area to implement GMP responsibilities within level of responsibility

determine action required to respond to GMP noncompliance within level of responsibility

participate in improvement processes such as investigating actual and potential GMP noncompliance

participate in andor review practices and procedures to prevent or minimise the likelihood of unacceptable performance

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of

the role of GMP in preventing contamination its relationship to legal requirements of pharmaceutical manufacturers and potential implications of noncompliance

GMP arrangements in the workplace including relevant GMP codes of practice and related workplace policies and procedures to implement these responsibilities

role of effective communication and consultation processes

workplace training and development system and responsibilities

role of quality assurance and related system components and activities in GMP

procedures followed to investigate contamination events and performance improvement processes

personal clothing and footwear requirements for working in andor moving between work areas

personal clothing use storage and disposal requirements

current technical and process knowledge required to monitor GMP and participate in investigating GMP noncompliance within level of responsibility including common microbiological physical and chemical contaminants conditions under which types of contamination eg crosscontamination are likely to occur related control methods and validation procedures and responsibilities

control methods and procedures used in the work area to maintain GMP including the purpose of control the consequences if not controlled and the method of control where relevant

methods used to monitor process control purpose and requirements of validation procedures and purpose of equipment calibration

recall and traceability procedures relevant to work area

line clearance procedures and responsibilities

properties handling and storage requirements of raw materials packaging components and final product handled and used in the work area

standards for materials equipment and utensils used in the work area

procedures for responding to outofspecification or unacceptable performanceoutcomes including procedures for identifying and isolating or quarantining materials or product of unacceptable quality within level of responsibility

documentation system and procedures including record keeping to meet both company and legal requirements procedures for developing andor reviewing workplace procedures and document control systems used in the workplace and responsibilities for reporting and recording information

housekeeping requirements and responsibilities relating to own work and where relevant use and storage of housekeepingcleaning equipment

waste collection recycling handling and disposal including handlingdisposal requirements for different types of waste such as hazardous waste where relevant

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 workplace context A simulated environment must provide access to a typical range of production equipment procedures and related documentation records and related resources to meet the requirements of the Therapeutic Goods Act

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

GMP is an ongoing and routine aspect of work responsibilities Assessors should collect sufficient evidence that the skills and knowledge of this unit are routinely applied to the work environment

Evidence of ability to

identify the components of GMP and related roles and responsibilities as they relate to work role

provide a role model to others in the workplace to support implementation of GMP

participate in GMP processes within level of responsibility Examples of these processes include validation line clearance equipment calibration change management maintenance of documentation This would typically be undertaken in a team context

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 questioning and workplace observation It may involve additional collection of evidence from a range of sources such as third party reports workplace documentation relating to GMP and real or simulated workplace contexts

Method of assessment

This unit is a core requirement for all pharmaceutical operators at AQF and could be assessed concurrently with other units relating to process improvement and supporting others such as

FDFPPLA Participate in improvement processes

FDFPPL3001A Participate in improvement processes

FDFPPLA Support and mentor individuals and groups

FDFPPL3003A Support and mentor individuals and groups

FDFPPLA Participate in an audit process

FDFPPL3005A Participate in an audit process

FDFTECA Participate in a HACCP team

FDFTEC3001A Participate in a HACCP team.

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

Work activities

Unacceptable plant or equipment condition

Validation

Legislative requirements

Quality assurance and related system components and activities