Modification History
Not applicable.
Unit Descriptor
Unit descriptor |
This unit of competency 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. It covers the skills and knowledge required to facilitate contamination control in a work area. |
Application of the Unit
Application of the unit |
This unit provides an overview of the cleaning and sanitation systems, equipment and procedures used in a pharmaceutical workplace. This unit applies to people working in supervisory or line management production/packaging roles. This person would typically work within defined cleaning, sanitation, change control and validation programs and procedures. They need to be aware of the systems, equipment and procedures used and are responsible to oversee implementation in 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. Contamination risks and related control measures are identified and implemented to meet GMP requirements |
1.1. Hazards that could present a contamination risk are identified by type, origin and product association 1.2. Hazards and related control measures, critical limits, monitoring and recording requirements are reviewed and meet GMP requirements 1.3. Control measures are verified or validated |
2. Review systems and procedures used to control risk of cross contamination |
2.1. Effective barriers and control systems to minimise risk of cross contamination are identified and meet GMP requirements 2.2. In-process and environmental monitoring occurs and is recorded as required by GMP 2.3. Cleaning procedures are validated according to validation procedures, roles and responsibilities 2.4. Line clearance checklists and procedures are followed in the work area 2.5. Personal hygiene and conduct of personnel in the work area meets GMP requirements 2.6. Operators have the required skills and knowledge required to support cleaning and sanitation and personal hygiene policies and procedures |
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 :
Basic microbiology
Sources of technical advice
Storage requirements
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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 document management systems related to controlling contamination 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:
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Method of assessment |
This unit could be assessed concurrently with other units of competency 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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Barriers and control systems |
Barriers and control systems include but are not limited to:
Refer to the Australian Code of Good Manufacturing Practice for Medicinal Products |
Codes , guidelines and technical standards |
Codes, guidelines and technical standards includes:
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Basic microbiology |
Basic microbiology covers the ability to source information on:
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Sources of technical advice |
Sources of technical advice include but are not limited to:
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Storage requirements |
Storage requirements may include but are not limited to:
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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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