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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD THAT HAS PASSED THE END DATE: 

Define concepts and terminology related to large-scale pharmaceutical manufacturing 
SAQA US ID UNIT STANDARD TITLE
256480  Define concepts and terminology related to large-scale pharmaceutical manufacturing 
ORIGINATOR
SGB Pharmacy 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY
-  
FIELD SUBFIELD
Field 09 - Health Sciences and Social Services Curative Health 
ABET BAND UNIT STANDARD TYPE PRE-2009 NQF LEVEL NQF LEVEL CREDITS
Undefined  Regular  Level 3  NQF Level 03  3 
REGISTRATION STATUS REGISTRATION START DATE REGISTRATION END DATE SAQA DECISION NUMBER
Passed the End Date -
Status was "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 
This unit standard is aimed at individuals who require a broad understanding of large-scale manufacturing. Individuals credited with this standard will be able to define the manufacturing environment and will have a clear understanding of the importance of documentation used during the manufacture of pharmaceutical products. They will also be able to describe the basic elements of quality management in pharmaceutical processes and procedures. 

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
It is assumed that the learner is competent in:
  • Communications at NQF Level 2.
  • The Unit Standards:
    > ID 256485: Apply ethical and legal behaviour in the pharmaceutical and health environment.
    > ID 256475: Explain pharmaceutical concepts and terms. 
    		•

    UNIT STANDARD RANGE 
    N/A 

    Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Describe the manufacturing environment. 

    ASSESSMENT CRITERIA     

    ASSESSMENT CRITERION 1 
    Regulations pertaining to a pharmaceutical manufacturing environment are identified with examples. 

    ASSESSMENT CRITERION 2 
    The impact of the physical environment on the manufacturing processes is explained with examples of both positive and negative effects. 
    ASSESSMENT CRITERION RANGE 
    Physical environment includes factory layout, health and safety, functionality, air control, regulatory requirements.
     

    ASSESSMENT CRITERION 3 
    The process flow in the manufacturing production environment is identified and described for at least three different pharmaceutical products. 

    ASSESSMENT CRITERION 4 
    The responsibility of the individual in maintaining regulatory and organisational policies is explained with examples. 

    ASSESSMENT CRITERION 5 
    Organisational reporting structures are explained in terms of regulatory requirements. 

    ASSESSMENT CRITERION 6 
    Terminology specific to the manufacturing environment is defined and used correctly in the workplace on a day-to day basis. 
    ASSESSMENT CRITERION RANGE 
    Terminology includes batch number, different dosage forms, shut down, calibration, validation, dossiers, critical process parameters, process instructions, scope of practice, work instructions, equipment logbooks.
     

    SPECIFIC OUTCOME 2 
    Explain the importance of documentation used during the manufacture of pharmaceutical products. 
    OUTCOME RANGE 
    Documentation includes process instructions, scope of practice, work instructions, equipment logbooks, organisational specific documentation. 

    ASSESSMENT CRITERIA     

    ASSESSMENT CRITERION 1 
    The documentation relevant to the manufacturing environment is identified and an explanation given of its purpose. 

    ASSESSMENT CRITERION 2 
    The importance of the relevant documentation is explained in terms of legislative and organisational requirements. 

    SPECIFIC OUTCOME 3 
    Describe the basic elements of quality management in the pharmaceutical manufacturing environment. 

    ASSESSMENT CRITERIA     

    ASSESSMENT CRITERION 1 
    The importance of dossiers in manufacturing pharmaceutical products is explained in terms of quality control which affects patient well-being and care. 

    ASSESSMENT CRITERION 2 
    Critical process parameters are identified and described in terms of the production of a high-quality product. 

    ASSESSMENT CRITERION 3 
    The role of the individual in terms of quality management is explained with examples of good and bad practices. 
    ASSESSMENT CRITERION RANGE 
    The role of the individual includes accuracy; cleanliness; compliance; ethics.
     


    UNIT STANDARD ACCREDITATION AND MODERATION OPTIONS 
  • Anyone assessing a learner against this unit standard must be registered as an assessor with the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA.
  • Moderators must be accredited and allocated by the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA. 
    		•

    UNIT STANDARD ESSENTIAL EMBEDDED KNOWLEDGE 
    The concepts:
  • Dossiers.
  • Product changes.
  • Process Instruction.
  • Scope of Practice.
  • Work Instruction.
  • Deviations.
  • Equipment Logbook. 
    		•

    UNIT STANDARD DEVELOPMENTAL OUTCOME 
    N/A 

    UNIT STANDARD LINKAGES 
    N/A 


    Critical Cross-field Outcomes (CCFO): 

    UNIT STANDARD CCFO WORKING 
    Work with others in a team.

    Refer to the following Specific Outcome:
  • Describe the manufacturing environment. 
    		•

    UNIT STANDARD CCFO ORGANISING 
    Organise oneself and ones activities.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO COLLECTING 
    Collect, analyse, organise, and critically evaluate information.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO COMMUNICATING 
    Communicate effectively.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO SCIENCE 
    Use science and technology.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO DEMONSTRATING 
    Understand the world as a set of related systems.

    Refer to all Specific Outcomes. 

    UNIT STANDARD ASSESSOR CRITERIA 
    N/A 

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

    UNIT STANDARD NOTES 
    N/A 

    QUALIFICATIONS UTILISING THIS UNIT STANDARD: 
      ID QUALIFICATION TITLE PRE-2009 NQF LEVEL NQF LEVEL STATUS END DATE PRIMARY OR DELEGATED QA FUNCTIONARY
    Elective  72049   National Certificate: Pharmacist Assistance  Level 3  NQF Level 03  Passed the End Date -
    Status was "Reregistered"     		 2023-06-30  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.