Required skills

Ability to

apply principles of risk management to identify critical facilities systems and equipment

identify and interpret validation documentation relating to qualification and validation requirements for a work area

participate in qualification and validation procedures within level of responsibility

identify and manage the impact of qualification and validation procedures on related processes or work areaspersonnel within level of responsibility

liaise with other relevant departmentsfunctions to coordinate and schedule validation processes

develop documentation to support qualification and validation according to required formats and within level of responsibility

ensure that operators in the work area have the

prepare workplace documentation in plain 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

principles and purpose of qualification and related procedures and responsibilities

principles and purpose of validation and related procedures and responsibilities

purpose and application of prospective concurrent and retrospective validation

data collection analysis and reporting requirements

scope application and timing of validation including any relevant circumstances that could trigger the need to validate or revalidate or justify not carrying out a validation process prior to production starting

relationship between validation and change control

equipment design drawings and process flow charting

relevant investigation methods including process capability and root cause analysis

recording and reporting requirements

training and assessment arrangements and responsibilities

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 relating to qualification and validation processes 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 Qualification processes may be simulated to allow a walk through of the process

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

Evidence of participation in a team responsible for validation processes This includes providing evidence developed by the candidate to

review the qualification and validation protocols to assess implications for a work area and related departmentsfunctions

participate in qualification procedures design qualification installation qualification operational qualification andor performance qualification

For example this could include conducting trials in the work area as part of performance qualification in a work area The assessment activity requires use andor development of checklists and tools in required formats to carry out qualification as part of a project team It also includes monitoring and reporting on outcomes

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 including procedures relating to qualification and validation

real or simulated workplace context

Method of assessment

This unit 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 and monitor Good Manufacturing Practice

FDFPH4002A Facilitate and monitor Good Manufacturing Practice

FDFPHA Facilitate contamination control

FDFPH4003A Facilitate contamination control

FDFPHA Participate in change control procedures

FDFPH4004A Participate in change control procedures

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

Design qualification

Installation qualification

Operational qualification

Performance qualification

Validation requirements

Validation protocol

Validation documentation