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 related to GMP together with a range of commercial production/packaging equipment and activities typical of commercial manufacturing businesses and that 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 to ensure that the skills and knowledge of this unit are routinely applied to the work environment.

Assessment must require the candidate to identify and demonstrate responsibilities for implementation of GMP in the workplace.

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 2 and could be assessed concurrently with other operational units.

Guidance information for assessment

To ensure consistency in one's 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.

Required skills

Ability to:

locate and follow workplace information relating to GMP responsibilities

identify and report situations that do or could compromise GMP

participate in procedures to support GMP within level of responsibility

identify and respond to out-of-specification or unacceptable raw materials, packaging components, final or part processed product within level of responsibility

use oral communication skills/language competence to fulfil the job role as specified by the organisation, including questioning, active listening, asking for clarification and seeking advice from supervisor

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 non-compliance

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

the relationship between GMP and the quality system, personnel responsible for designing and managing GMP, personal role to maintain GMP, and the role of internal and external auditors as appropriate

procedures followed to investigate contamination events and performance improvement processes

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

personal clothing use, storage and disposal requirements

awareness of common micro-biological, physical and chemical contaminants relevant to the work process, including the types of contamination likely to occur, such as cross-contamination, the conditions under which they occur, possible consequences and control methods to prevent occurrence

basic concepts of quality assurance, including quality specifications, operating parameters, validation procedures and control methods, and related documentation, including standard operating procedures (SOPs) and/or batch instructions

control methods and procedures used in the work area to maintain GMP, including an understanding of the purpose of control, the consequence if not controlled and the method of control where relevant, as well as an understanding of the methods used to monitor process control

basic understanding of the properties, handling and storage requirements of raw materials, packaging components and final product handled and used

standards for materials, equipment and utensils used in the work area

procedures for responding to out-of-specification or unacceptable performance/outcomes

purpose of keeping records and the recording requirements of GMP, including product and materials traceability procedures

housekeeping requirements and responsibilities relating to own work, and use and storage of housekeeping/cleaning equipment where relevant

waste collection, recycling and handling procedures relevant to own work responsibilities

responsibilities for reporting and recording quality information

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Policies and procedures

Work activities are carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements

Unacceptable plant or equipment condition

Unacceptable plant or equipment condition can include:

damage to plant or equipment

failure of cleaning regime

signs of pest infestation

Legislative requirements

Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:

relevant GMP codes

the Therapeutic Goods Act

other legislation and codes relevant to product and market

legislation relating to environmental management, occupational health and safety (OHS), anti-discrimination and equal opportunity