Modification History
Not applicable.
Unit Descriptor
Unit descriptor |
This unit of competency covers the skills and knowledge required to comply with relevant Good Manufacturing Practice (GMP) codes and workplace quality standards. |
Application of the Unit
Application of the unit |
This unit has application in a pharmaceutical manufacturing environment. Responsibility for applying GMP relates to the person's work area. |
Licensing/Regulatory Information
Not applicable.
Pre-Requisites
Prerequisite units |
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Employability Skills Information
Employability skills |
This unit contains employability skills. |
Elements and Performance Criteria Pre-Content
Elements describe the essential outcomes of a unit of competency. |
Performance criteria describe the performance needed to demonstrate achievement of the element. Where bold italicised text is used, further information is detailed in the required skills and knowledge section and the range statement. Assessment of performance is to be consistent with the evidence guide. |
Elements and Performance Criteria
ELEMENT |
PERFORMANCE CRITERIA |
1. Identify requirements of GMP related to own work |
1.1. Sources of information on GMP requirements are located 1.2. GMP requirements and responsibilities related to own work are identified |
2. Observe personal hygiene and conduct to meet GMP requirements |
2.1. Personal hygiene meets GMP requirements 2.2. Clothing is prepared, used, stored and disposed of according to GMP and workplace procedures 2.3. Personal movement around the workplace complies with area entry and exit procedures |
3. Follow GMP requirements when carrying out work activities |
3.1. GMP requirements are identified 3.2. Work area, materials, equipment and product are routinely monitored to ensure compliance with GMP requirements 3.3. Raw materials, product and packaging components are handled according to GMP and workplace procedures 3.4. Contamination is identified and appropriate control measures are followed relating to work responsibilities and according to GMP requirements 3.5. Processes, practices or conditions which are not consistent with GMP are identified and reported according to workplace reporting procedure 3.6. The workplace is maintained in a clean and tidy order to meet GMP housekeeping standards 3.7. Work is conducted in accordance with workplace environmental guidelines |
4. Complete workplace documentation to support GMP |
4.1. Documentation and recording requirements are identified 4.2. Information is recorded according to workplace reporting procedures to meet GMP requirements |
Required Skills and Knowledge
REQUIRED SKILLS AND KNOWLEDGE |
This section describes the skills and knowledge required for this unit. |
Required skills |
Ability to :
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Required knowledge |
Knowledge of :
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Evidence Guide
EVIDENCE GUIDE |
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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. |
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Overview of assessment |
Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations. |
Critical aspects for assessment and evidence required to demonstrate competency in this unit |
Evidence of ability to:
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Context of and specific resources for assessment |
Assessment must occur in a real or simulated workplace where the assessee has access to:
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Method of assessment |
This unit should be assessed together with other units of competency relevant to the work role. An example could be:
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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. |
Range Statement
RANGE STATEMENT |
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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. |
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Policies and procedures |
Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements |
Legislative requirements |
Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:
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Reporting systems |
Reporting systems may include:
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Unit Sector(s)
Unit sector |
Pharmaceutical manufacturing |
Competency field
Competency field |
Co-requisite units
Co-requisite units |
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