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Elements and Performance Criteria

1. Identify requirements of GMP related to own work
   • Sources of information on GMP requirements arelocated
   • GMP requirements and responsibilities relatedto own work are identified
2. Observe personal hygiene and conduct to meet GMP requirements
   • Personal hygiene meets GMP requirements
   • Clothing is prepared, used, stored anddisposed of according to GMP and workplace procedures
   • Personal movement around the workplacecomplies with area entry and exit procedures
3. Follow GMP requirements when carrying out work activities
   • GMP requirements are identified
   • Work area, materials, equipment and productare routinely monitored to ensure compliance with GMPrequirements
   • Raw materials, product and packagingcomponents are handled according to GMP and workplaceprocedures
   • Contamination is identified and appropriatecontrol measures are followed relating to work responsibilities andaccording to GMP requirements
   • Processes, practices or conditions which arenot consistent with GMP are identified and reported according toworkplace reporting procedure
   • The workplace is maintained in a clean andtidy order to meet GMP housekeeping standards
4. Complete workplace documentation to support GMP
   • Documentation and recording requirements areidentified
   • Information is recorded according to workplacereporting procedures to meet GMP requirements

Required Skills

Not applicable

Evidence Required

The assessment process must address all of the following items of evidence

Ability to

Locate and follow workplace information relating to GMP responsibilities

Maintain personal hygiene consistent with GMP

Follow workplace procedures when moving around the workplace andor from one task to another to maintain GMP

Use store and dispose of appropriate clothing footwear as required by work tasks and consistent with GMP

Carry out relevant checks and inspections as required This may include visual checks and inspections on equipment andor raw materials product packaging components and processing conditions relevant to own work

Identify and respond to outofspecification or unacceptable conditions or performance This may include making adjustments within level of responsibility andor reporting

Follow GMP when carrying out work functions

Identify and report situations that do or could compromise GMP

Handle andor dispose of outofspecification or contaminated materials packaging componentsconsumables and product waste and recyclable material according to GMP as required by work responsibilities

Maintain the work area in a clean and tidy state

Identify and report signs of pest infestation

Knowledge of

The role of GMP in preventing contamination its relationship to legislative responsibilities and potential implications of noncompliance

The relationship between the Code of Good Manufacturing Practice and workplace procedures systems and processes

GMP personnel and their respective responsibilities

Personal role responsibility and accountability for implementing GMP

Sources of advice on GMP requirements for own work

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

Personal clothing use storage and disposal requirements

Common types and sources of contamination that occurs in the work area

Control methods and procedures used in the work area to maintain GMP This includes an understanding of the purpose of control the consequence if not controlled and the method of control where relevant

Monitoring inspection and checking procedures relating to process control requirements

Standards for materials equipment and utensils used in the work area

Evidence of outofstandard or unacceptable performance

Action required in the event of noncompliance

Storage and handling requirements for raw materials packaging components and product relevant to work role

Housekeeping requirements and responsibilities relating to own work Where relevant this includes use and storage of housekeepingcleaning equipment

Waste collection recycling and handling procedures relevant to own work responsibilities

Responsibilities for reporting and recording quality information

The assessment process must address all of the following items of evidence

Ability to

Locate and follow workplace information relating to GMP responsibilities

Maintain personal hygiene consistent with GMP

Follow workplace procedures when moving around the workplace andor from one task to another to maintain GMP

Use store and dispose of appropriate clothing footwear as required by work tasks and consistent with GMP

Carry out relevant checks and inspections as required This may include visual checks and inspections on equipment andor raw materials product packaging components and processing conditions relevant to own work

Identify and respond to outofspecification or unacceptable conditions or performance This may include making adjustments within level of responsibility andor reporting

Follow GMP when carrying out work functions

Identify and report situations that do or could compromise GMP

Handle andor dispose of outofspecification or contaminated materials packaging componentsconsumables and product waste and recyclable material according to GMP as required by work responsibilities

Maintain the work area in a clean and tidy state

Identify and report signs of pest infestation

Knowledge of

The role of GMP in preventing contamination its relationship to legislative responsibilities and potential implications of noncompliance

The relationship between the Code of Good Manufacturing Practice and workplace procedures systems and processes

GMP personnel and their respective responsibilities

Personal role responsibility and accountability for implementing GMP

Sources of advice on GMP requirements for own work

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

Personal clothing use storage and disposal requirements

Common types and sources of contamination that occurs in the work area

Control methods and procedures used in the work area to maintain GMP This includes an understanding of the purpose of control the consequence if not controlled and the method of control where relevant

Monitoring inspection and checking procedures relating to process control requirements

Standards for materials equipment and utensils used in the work area

Evidence of outofstandard or unacceptable performance

Action required in the event of noncompliance

Storage and handling requirements for raw materials packaging components and product relevant to work role

Housekeeping requirements and responsibilities relating to own work Where relevant this includes use and storage of housekeepingcleaning equipment

Waste collection recycling and handling procedures relevant to own work responsibilities

Responsibilities for reporting and recording quality information

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Range Statement

The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.

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

- Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes relevant Good Manufacturing Practice (GMP) codes, the Therapeutic Goods Act, labelling, weights and measures legislation and legislation covering environmental management, occupational health and safety, anti-discrimination and equal opportunity

- Responsibility for applying good manufacturing practice relates to the person's work area

- Reporting systems may include electronic and manual data recording and storage systems

The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.

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

- Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes relevant Good Manufacturing Practice (GMP) codes, the Therapeutic Goods Act, labelling, weights and measures legislation and legislation covering environmental management, occupational health and safety, anti-discrimination and equal opportunity

- Responsibility for applying good manufacturing practice relates to the person's work area

- Reporting systems may include electronic and manual data recording and storage systems

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