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Elements and Performance Criteria

  1. Ensure others in the work area are able to meet GMP requirements
  2. Monitor personal hygiene and conduct of team members in the work area
  3. Monitor implementation of GMP requirements in the work area
  4. Contribute to validation processes
  5. Take corrective action in response to GMP non-compliance
  6. Maintain and improve GMP in the work area

Evidence Required

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

Ability to

Communicate information about GMP requirements and related procedures to others in the work area This requires demonstration of twoway communication including active listening and constructive response to feedback

Provide access to GMP documentation

Model personal conduct and work activities to meet requirements of GMP

Identify control points in work area and demonstrate monitoring techniques used

Support others to identify control points and demonstrate monitoring and control methods

Support others to follow GMP procedures This includes validation procedures within level of responsibility

Ensure that appropriate and timely action is taken in response to noncompliance

Determine action required to respond to GMP noncompliance within level of responsibility

Participate in consultation processes to improve GMP This may include investigating actual and potential GMP noncompliance

Participate in andor review practices and procedures to prevent or minimise the likelihood of unacceptable performance

Ensure that housekeeping standards are maintained and that equipment is in operational order This may include participating in the management of equipment calibration

Monitor the recording of GMP information to confirm that records accurately reflect performance and meet the requirements of the workplace and legislation

Knowledge of

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

GMP arrangements in the workplace This includes awareness of 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 the role of internal and external auditors as appropriate

Procedures followed to investigate contamination events and performance improvement processes

Clothing and footwear requirements for working in andor moving between work areas

Current technical and process knowledge required to monitor GMP and participate in investigating GMP noncompliance within level of responsibility This includes an understanding of common microbiological physical and chemical contaminants conditions under which types of contamination are likely to occur related control methods and validation procedures and responsibilities

Basic concepts of quality assurance including quality specifications operating parameters validation procedures and control methods This includes an understanding of related documentation including Standard Operating Procedures andor batch instructions

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 It also includes an understanding of the methods used to monitor process control

Purpose and requirements of validation procedures and purpose of equipment calibration

Recall and traceability procedures relevant to work area

GMP responsibilities and requirements relating to the work area

Properties handling and storage requirements of raw materials packaging components and final product handled and used in the work area

Standards for materials equipment and utensils used in the work area

Procedures for responding to outofspecification or unacceptable performanceoutcomes This includes procedures for identifying and isolating or quarantining materials or product of unacceptable quality

Documentation system and procedures This includes record keeping to meet both company and legal requirements procedures for developing andor reviewing workplace procedures and document control systems used in the workplace

Auditing arrangements roles and responsibilities as they relate to own work responsibilities This may include an understanding of the purpose and process for internal and external audit processes

Appropriate communication skills and techniques to convey information appropriate to audience

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

Waste collection recycling handling and disposal This may include handlingdisposal requirements for different types of waste such as hazardous waste where relevant

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

Ability to

Communicate information about GMP requirements and related procedures to others in the work area This requires demonstration of twoway communication including active listening and constructive response to feedback

Provide access to GMP documentation

Model personal conduct and work activities to meet requirements of GMP

Identify control points in work area and demonstrate monitoring techniques used

Support others to identify control points and demonstrate monitoring and control methods

Support others to follow GMP procedures This includes validation procedures within level of responsibility

Ensure that appropriate and timely action is taken in response to noncompliance

Determine action required to respond to GMP noncompliance within level of responsibility

Participate in consultation processes to improve GMP This may include investigating actual and potential GMP noncompliance

Participate in andor review practices and procedures to prevent or minimise the likelihood of unacceptable performance

Ensure that housekeeping standards are maintained and that equipment is in operational order This may include participating in the management of equipment calibration

Monitor the recording of GMP information to confirm that records accurately reflect performance and meet the requirements of the workplace and legislation

Knowledge of

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

GMP arrangements in the workplace This includes awareness of 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 the role of internal and external auditors as appropriate

Procedures followed to investigate contamination events and performance improvement processes

Clothing and footwear requirements for working in andor moving between work areas

Current technical and process knowledge required to monitor GMP and participate in investigating GMP noncompliance within level of responsibility This includes an understanding of common microbiological physical and chemical contaminants conditions under which types of contamination are likely to occur related control methods and validation procedures and responsibilities

Basic concepts of quality assurance including quality specifications operating parameters validation procedures and control methods This includes an understanding of related documentation including Standard Operating Procedures andor batch instructions

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 It also includes an understanding of the methods used to monitor process control

Purpose and requirements of validation procedures and purpose of equipment calibration

Recall and traceability procedures relevant to work area

GMP responsibilities and requirements relating to the work area

Properties handling and storage requirements of raw materials packaging components and final product handled and used in the work area

Standards for materials equipment and utensils used in the work area

Procedures for responding to outofspecification or unacceptable performanceoutcomes This includes procedures for identifying and isolating or quarantining materials or product of unacceptable quality

Documentation system and procedures This includes record keeping to meet both company and legal requirements procedures for developing andor reviewing workplace procedures and document control systems used in the workplace

Auditing arrangements roles and responsibilities as they relate to own work responsibilities This may include an understanding of the purpose and process for internal and external audit processes

Appropriate communication skills and techniques to convey information appropriate to audience

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

Waste collection recycling handling and disposal This may include handlingdisposal requirements for different types of waste such as hazardous waste where relevant


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

- Products/materials handled and stored can include raw materials, packaging components and consumables, part-processed product, finished product and cleaning materials

- 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

- Products/materials handled and stored can include raw materials, packaging components and consumables, part-processed product, finished product and cleaning materials

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