Modification History
Not applicable.
Unit Descriptor
Unit descriptor |
This unit of competency covers the skills and knowledge required by production/packaging line managers or supervisors to develop, review and manage workplace documentation to support Good Manufacturing Practice (GMP). This units targets content outlined in Chapter 4 of the Australian Code of Good Manufacturing Practice for Medicinal Products and should be read in conjunction with this document. |
Application of the Unit
Application of the unit |
This unit applies to people working in a supervisory or line management production/packaging role. Their responsibilities for document design, review and maintenance would typically require them to work in close consultation with others and focus on documentation relevant to their 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. Develop and/or review workplace documentation to meet GMP requirements |
1.1. Policies and master plans are identified to determine work area requirements 1.2. Workplace documentation is identified and reviewed to confirm GMP requirements are met 1.3. Procedures and records are developed and/or reviewed to confirm GMP requirements are met 1.4. Improvements to workplace documentation are identified and reported 1.5. Procedures to alter workplace documents are followed |
2. Facilitate development and communication of workplace documentation |
2.1. Workplace documentation is developed in consultation with relevant stakeholders to support GMP 2.2. Documentation is made available and clearly explained to relevant stakeholders 2.3. Training requirements are identified and addressed within level of responsibility |
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 may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and related document control and management systems that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial manufacturing packaging equipment and activities typically used in a commercial manufacturing environment. |
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 |
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 responding to 'what if' scenarios, answering questions and conducting workplace projects. Resources for assessment include:
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Method of assessment |
This unit is a core requirement for all pharmaceutical operators at AQF 4 and 5. This unit could be assessed concurrently with other units relating to problem solving and process improvement. Examples 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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Workplace documentation |
Workplace documentation may include but is not limited to:
Documentation typically includes:
Information is typically stored and accessed electronically |
Procedures and records |
Information covered by procedures includes but is not limited to:
Records should include but are not limited to:
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Stakeholders |
Stakeholders refer to process and technical experts and may include but are not limited to:
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Version control |
Version control includes:
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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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