Required skills

Ability to

locate regulations codes guides and internal company documentation relevant to GMP and productsprocesses used in the work area

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

ensure that operators have the

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

legislative framework and structure including the role of regulations codes and guides

corporate and personal responsibility and liability for maintaining GMP in the workplace

the Pharmaceutical Inspection Cooperation Scheme PICS and related crossrecognition agreements

the content covered by the Therapeutic Goods Act relevant codes and guides

sources of technical advice on test methods and critical limits

regulatory mechanisms including audit processes

the principles of quality management quality assurance and quality control and the role of these activities in supporting GMP

principles of risk management and related procedures

system for raising and managing corrective and preventative actions

specific requirements to be met by manufacturing andor packaging activities in the work area to meet GMP requirements

calibration programs and responsibilities

procedures for reconciling materials and consumables and investigating discrepancies

training system including assessment methods and documentation

purpose procedure and responsibility for specific systems programs and procedures to support GMP

root cause analysis techniques

workplace documentation and authorisation procedures

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 GMP that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act It will also provide a range of commercial productionpackaging 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 participation in a project team to develop or review systems and procedures to support GMP in a work area This includes providing evidence that the candidate

provides documented evidence through use of workplace documentation and records to show that the work preparation processing and completion meet GMP requirements

leads response to a failure or nonconformance in the work area This must include conducting risk assessment analysing root cause analysis identifying corrective and preventive action and monitoring implementation This aspect of assessment may be undertaken as part of a team

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

Method of assessment

This unit is a core requirement for all pharmaceutical operators at AQF and It could be assessed concurrently with other units 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 contamination control

FDFPH4003A Facilitate contamination control

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

Regulations, codes and guides

Workplace documentation

Work practices

Sources of technical advice

Systems, programs and procedures to support GMP