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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD: 

Demonstrate knowledge of Good Manufacturing Practices in a Chemical Manufacturing enviroment 
SAQA US ID UNIT STANDARD TITLE
14804  Demonstrate knowledge of Good Manufacturing Practices in a Chemical Manufacturing enviroment 
ORIGINATOR
Chemical Industries SGB 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY
-  
FIELD SUBFIELD
Field 06 - Manufacturing, Engineering and Technology Engineering and Related Design 
ABET BAND UNIT STANDARD TYPE PRE-2009 NQF LEVEL NQF LEVEL CREDITS
Undefined  Regular  Level 2  NQF Level 02 
REGISTRATION STATUS REGISTRATION START DATE REGISTRATION END DATE SAQA DECISION NUMBER
Reregistered  2018-07-01  2023-06-30  SAQA 06120/18 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2024-06-30   2027-06-30  

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.  

This unit standard does not replace any other unit standard and is not replaced by any other unit standard. 

PURPOSE OF THE UNIT STANDARD 
A person credited with this standard is able to demonstrate knowledge of good manufacturing practices as it pertains to:
  • self and others
  • use of tools and equipment
  • material and product handling and storage
  • environment and facility documentation 

  • LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
    It is assumed that people learning towards this unit standard, have:
  • Literacy NQF level 1 (ABET 4 language and communication skills)
  • Numeracy NQF level 1 (ABET 4 Mathematics) or equivalent competencies 

  • UNIT STANDARD RANGE 
    Range statements applicable to the specific outcomes and assessment criteria are found beneath the applicable specific outcomes or assessment criteria. 

    Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Demonstrate knowledge of GMP as it relates to self and others. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    1. The importance of using correct dress code and personal protective equipment (PPE) is described in terms of their potential effect on self, others and product quality. 
    ASSESSMENT CRITERION RANGE 
    Effect on self and others includes health, safety and hygiene.
     

    ASSESSMENT CRITERION 2 
    2. The importance of following safety requirements, and the potential consequences of deviating from safety requirements, are described in terms of the effect on self, others, equipment, environment, product quality, productivity and legal consequences. 

    ASSESSMENT CRITERION 3 
    3. The importance of following personal health and hygiene practices, in accordance with company SOPs and policy, is described in terms of their potential effect on self, others and product quality. 

    SPECIFIC OUTCOME 2 
    Demonstrate knowledge of GMP as it pertains to the use of tools and equipment. 
    OUTCOME RANGE 
    Material is defined as raw material (ingredients and components
    Product is defined as intermediate or finished product. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    1. The correct and safe handling of equipment and tools is explained and/or demonstrated as per company SOPs. Explanations are provided of the importance of using the correct equipment and tools. 
    ASSESSMENT CRITERION RANGE 
    Correct refers to: status, condition and type for the job.
    Requirements could be stipulated through SOPs, signage, labeling and company documentation.
     

    ASSESSMENT CRITERION 2 
    2. Explanations are provided of the importance of correctly identifying and documenting equipment or tool status and condition. Descriptions of corrective actions in the case of deviations are consistent with company SOPs. 

    SPECIFIC OUTCOME 3 
    Demonstrate knowledge of GMP as it pertains to material and product handling and storage. 
    OUTCOME RANGE 
    Material is defined as raw material (ingredients and components
    Product is defined as intermediate or finished product. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    1. The importance of following correct handling and storing procedures, as per SOPs, signage, labels and documentation is described in terms of potential effect on people, product, quality and environment. 

    ASSESSMENT CRITERION 2 
    2. Descriptions are provided of possible causes of contamination. 

    ASSESSMENT CRITERION 3 
    3. Explanations are provided of the importance of maintaining material and product integrity. 
    ASSESSMENT CRITERION RANGE 
    Integrity encompasses batch separation, identification and security of materials or products, storage conditions and materials flow.
     

    ASSESSMENT CRITERION 4 
    4. Explanations of the importance of verifying material and product status at all stages are consistent with company SOPs. 

    ASSESSMENT CRITERION 5 
    5. Descriptions of the meaning of different status conditions are consistent with industry usage. 
    ASSESSMENT CRITERION RANGE 
    Status can imply any of the following:
  • Quarantined/on-hold/frozen
  • Released/approved/saleable
  • Rejected
     

  • SPECIFIC OUTCOME 4 
    Demonstrate knowledge of GMP as it pertains to the environment and facility. 
    OUTCOME RANGE 
    Immediate work area, common work area. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    1. Explanations are provided for possible ways in which environmental conditions can affect product quality. The explanations are consistent with relevant documentation. 
    ASSESSMENT CRITERION RANGE 
    The environmental conditions may include air-conditioning, air-flow, air pressures, temperature, humidity, lighting, housekeeping, security and safety.
     

    ASSESSMENT CRITERION 2 
    2. Good housekeeping and hygiene practices are described in accordance with legal and company-specific requirements. 
    ASSESSMENT CRITERION RANGE 
    Good housekeeping and hygiene practices include not eating, smoking or drinking, waste-disposal, pest-control, maintenance, safety, cleanliness and people movement.
     

    SPECIFIC OUTCOME 5 
    Demonstrate knowledge of GMP as it pertains to documentation. 
    OUTCOME RANGE 
    Any relevant company documentation and SOPs. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    1. The importance of completing and understanding documentation correctly is explained. 

    ASSESSMENT CRITERION 2 
    2. Documentation availability and retrieval is demonstrated. 

    SPECIFIC OUTCOME 6 
    Demonstrate an understanding of the application of GMP in industry. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    1. The principles of GMP are explained with reference to the structure on site that is used to apply GMP. 
    ASSESSMENT CRITERION RANGE 
    Structures include organisational structure, suitable facilities and equipment, SOPs, documentation, Analytical testing.
     

    ASSESSMENT CRITERION 2 
    2. The role GMP in quality assurance is explained with reference to audits. 


    UNIT STANDARD ACCREDITATION AND MODERATION OPTIONS 
    Assessment options:
    1. Oral or written questions.
    2. Direct observations in simulated or actual work conditions
    3. Examination of relevant documentation. 

    UNIT STANDARD ESSENTIAL EMBEDDED KNOWLEDGE 
  • Knowledge of the site specific technology
  • Safety, health, hygiene and environmental 


  • Critical Cross-field Outcomes (CCFO): 

    UNIT STANDARD CCFO IDENTIFYING 
    Identifying and solving problems in which responses display that responsible decisions using critical and creative thinking have been made. 

    UNIT STANDARD CCFO WORKING 
    Working effectively with others as a member of a team. 

    UNIT STANDARD CCFO ORGANISING 
    Organising and managing oneself and one`s activities responsibly and effectively. 

    UNIT STANDARD CCFO COMMUNICATING 
    Communicating effectively using visual, mathematical and/or language skills in the modes of oral and/or written persuasion. 

    UNIT STANDARD CCFO SCIENCE 
    Using science and technology effectively and critically, showing responsibility towards the environment and health of others. 

    UNIT STANDARD CCFO DEMONSTRATING 
    Show responsibility towards oneself and others in accordance with the Health and Safety legislation and regulations.
    Understand how the incorrect storage and handling of products will have a negative impact on products, clients, customers and business. 

    UNIT STANDARD CCFO CONTRIBUTING 
    Contributing to the full personal development of each learner and the social and economic development of the society at large, by making it the underlying intention of any programme of learning to make an individual aware of the importance of:
    (i) reflecting on and exploring a variety of strategies to learn more effectively;
    (ii) participating as responsible citizens in the life of local, national and global
    communities;
    (iii) being culturally and aesthetically sensitive across a range of social contexts. 

    REREGISTRATION HISTORY 
    As per the SAQA Board decision/s at that time, this unit standard was Reregistered in 2012; 2015. 

    QUALIFICATIONS UTILISING THIS UNIT STANDARD: 
      ID QUALIFICATION TITLE PRE-2009 NQF LEVEL NQF LEVEL STATUS END DATE PRIMARY OR DELEGATED QA FUNCTIONARY
    Elective  66029   General Education and Training Certificate: Chemical Operations  Level 1  NQF Level 01  Reregistered  2023-06-30  As per Learning Programmes recorded against this Qual 
    Elective  22865   National Certificate: Chemical Operations  Level 1  NQF Level 01  Passed the End Date -
    Status was "Registered" 
    2005-10-09  Was CHIETA until Last Date for Achievement 
    Elective  58955   National Certificate: Chemical Manufacturing  Level 2  NQF Level 02  Reregistered  2023-06-30  CHIETA 
    Elective  58975   National Certificate: Automated Packaging Operations  Level 3  NQF Level 03  Reregistered  2021-06-30  As per Learning Programmes recorded against this Qual 


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS UNIT STANDARD: 
    This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.
     
    NONE 



    All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.