EVIDENCE GUIDE The evidence provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package. Overview of Assessment The assessment environment provides access to documentation related to controlled environments together with a range of activities typical of commercial manufacturing operations, and that meet the requirements of the Australian Code of current GMP. Critical aspects for assessment To demonstrate competence in this unit, a candidate must provide and evidence required to evidence of the application of their knowledge to: demonstrate competency in this describe the characteristics of controlled environments, unit describe the operating parameters of controlled environments, follow pre-entry requirements, follow required work practices appropriate to controlled environments, follow exit procedures Context of and specific Assessors must be satisfied that the person can consistently resources for assessment perform the unit including all elements and performance criteria, and can demonstrate the required skills and knowledge. Resources for assessment include: a range of relevant exercises, case studies and/or other practical and knowledge assessment, and/or access to an appropriate range of relevant operational situations gowning/degowning procedures and related advice on equipment operation, including advice on safe work practices and environmental requirements personal protective clothing and equipment information relating to the design, operation, testing and monitoring of Air Handling Units / Heating Ventilations and Air Conditioning (HVAC) information relating to the regulatory and management issues associated with controlled environments, relevant to work responsibilities examples of data collection forms and information recording systems, requirements, procedures and examples of data.
EVIDENCE GUIDE The evidence provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package. Overview of Assessment The assessment environment provides access to documentation related to controlled environments together with a range of activities typical of commercial manufacturing operations, and that meet the requirements of the Australian Code of current GMP. Critical aspects for assessment and evidence required to demonstrate competency in this unit To demonstrate competence in this unit, a candidate must provide evidence of the application of their knowledge to: describe the characteristics of controlled environments, describe the operating parameters of controlled environments, follow pre-entry requirements, follow required work practices appropriate to controlled environments, follow exit procedures Context of and specific resources for assessment Assessors must be satisfied that the person can consistently perform the unit including all elements and performance criteria, and can demonstrate the required skills and knowledge. Resources for assessment include: a range of relevant exercises, case studies and/or other practical and knowledge assessment, and/or access to an appropriate range of relevant operational situations gowning/degowning procedures and related advice on equipment operation, including advice on safe work practices and environmental requirements personal protective clothing and equipment information relating to the design, operation, testing and monitoring of Air Handling Units / Heating Ventilations and Air Conditioning (HVAC) information relating to the regulatory and management issues associated with controlled environments, relevant to work responsibilities examples of data collection forms and information recording systems, requirements, procedures and examples of data.
curr22450VIC%20PHARMANFPRINCIPLES.docx