Required skills

Ability to

use workplace documentation recording and reporting formats and software

prepare workplace documentation inplain English and suited to purpose and audience

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

documentation requirements as outlined in Chapter of the Australian Code of Good Manufacturing Practice for Medicinal Products

document authorisation requirements and procedures and legal responsibilities of signatory

document types to support workplace systems and related development and control systems roles and responsibilities including an understanding of system security and access levels

procedures and responsibilities for altering documents and managing version control

systems methods and procedures for recording and storing data and authorised levels of access to electronic systems

use of documentation including an understanding of the documents that can be used as evidence in audit processes

recording and reporting requirements

training and assessment arrangements and responsibilities

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 related document control and management systems 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

review workplace documentation to confirm that it meets GMP requirements Documentation may relate to a specific work area rather than the whole plant The candidate is required to document their findings

develop design or amend documentation to support GMP For example this could require the development of operating procedures It may include reviewing and updating existing documentation or developing new documentation within required formats The candidate must demonstrate application of document control procedures to submit or amend documents They must also demonstrate that appropriate consultation was undertaken in the development process and the document changes are effectively communicated This includes demonstrating an awareness of the link to related documents Where training needs arise from the change these must be identified together with recommendations for how they can be addressed

review completed GMPrelated documents and records to ensure that GMP requirements are met

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 include

Australian Code of Good Manufacturing Practice for Medicinal Products

workplace documentation and related document control and management system

workplace personnel

real or simulated workplace context

Method of assessment

This unit is a core requirement for all pharmaceutical operators at AQF and This unit could be assessed concurrently with other units relating to problem solving and process improvement Examples could be

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.

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

Workplace documentation

Procedures and records

Stakeholders

Version control