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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD: 

Implement quality assurance in a pharmaceutical manufacturing environment 
SAQA US ID UNIT STANDARD TITLE
256555  Implement quality assurance in a pharmaceutical manufacturing environment 
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 4  NQF Level 04  10 
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 
This unit standard enables individuals to implement quality assurance practices in the pharmaceutical manufacturing environment. Specifically individuals will develop an understanding of total quality management in manufacturing with specific emphasis on the importance of dossiers, deviations and critical process parameters. 

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
It is assumed that the learner is competent in:
  • Communication at NQF Level 3.
  • Mathematical Literacy at NQF Level 3.

    The unit Standard:
  • ID 14927: Apply problem solving strategies. 

  • UNIT STANDARD RANGE 
    N/A 

    Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Describe total quality management. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The need for consistent processes and standards to achieve quality is explained with examples of the consequences of non compliance. 

    ASSESSMENT CRITERION 2 
    Purpose of quality control during manufacturing is explained with examples. 

    ASSESSMENT CRITERION 3 
    Purpose of quality assurance during manufacturing is explained with examples. 

    ASSESSMENT CRITERION 4 
    The processes required to control quality during manufacturing are explained with examples in accordance with the regulatory framework. 
    ASSESSMENT CRITERION RANGE 
    Processes include corrective and preventive actions, approved vendor lists, standard operating procedures.
     

    ASSESSMENT CRITERION 5 
    Quality control and quality assurance are described in relation to total quality management. 

    SPECIFIC OUTCOME 2 
    Explain the use of dossiers in manufacturing pharmaceutical products. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Different sections of a dossier are identified and their contents are described. 

    ASSESSMENT CRITERION 2 
    Product changes which need not be reflected in the dossier are explained with examples. 

    ASSESSMENT CRITERION 3 
    Product changes which must be reflected in the dossier are explained. 

    ASSESSMENT CRITERION 4 
    The purpose of the dossier is explained in terms of quality management. 

    SPECIFIC OUTCOME 3 
    Identify critical process parameters. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Critical points and critical process parameters are defined in terms of quality assurance in the system. 

    ASSESSMENT CRITERION 2 
    The critical process parameters within a manufacturing process are identified and the importance explained in terms of quality assurance. 
    ASSESSMENT CRITERION RANGE 
    Critical process parameters include pH, volume, addition of actives, particle size.
     

    ASSESSMENT CRITERION 3 
    The critical process parameters within a packaging process are identified and the importance explained in terms of quality assurance. 

    ASSESSMENT CRITERION 4 
    The role of the critical points is explained in terms of quality management. 

    SPECIFIC OUTCOME 4 
    Discuss deviations in terms of total quality management. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Planned and unplanned deviations are explained with examples of their impact on the organisation and the product. 

    ASSESSMENT CRITERION 2 
    The potential outcomes of planned and unplanned deviations are explained with examples. 

    ASSESSMENT CRITERION 3 
    Processes to follow when deviations occur are followed in line with organisational SOP and legal requirements. 

    ASSESSMENT CRITERION 4 
    The role of compliance is explained in terms of quality management. 


    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:
  • Manufacturing process.
  • Packaging process.
  • Deviations.
  • Legal requirements. 

  • 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 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  72050   Further Education and Training Certificate: Pharmacist Assistance  Level 4  NQF Level 04  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.