SAQA 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.
SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD: 

Manufacture pharmaceutical products on a large scale 
SAQA US ID UNIT STANDARD TITLE
256481  Manufacture pharmaceutical products on a large scale 
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  12 
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 is aimed at individuals who require a broad understanding of the manufacturing of pharmaceutical products. Individuals credited with this standard will be able to prepare for a production process, including the verification of starting materials. In addition the individual will be able to participate in manufacturing of a product and quality control. They will also have the ability to participate in the storage of products and the shut down process. 

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
It is assumed that the learner is competent in:
  • Communication at NQF Level 2.
  • Mathematical Literacy 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.
  • ID 256480: Define concepts and terminology related to large-scale pharmaceutical manufacturing. 

  • UNIT STANDARD RANGE 
    N/A 

    Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Prepare for a production process. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The Process Instruction is obtained from the authorised person according to the planning schedule. 

    ASSESSMENT CRITERION 2 
    The necessary equipment required is identified according to the Process Instruction, confirmed as "fit for purpose" and moved to the manufacture area, if necessary. 
    ASSESSMENT CRITERION RANGE 
    Fit for purpose includes being clean, in accordance with the Standard Operating Procedure, labelled.
     

    ASSESSMENT CRITERION 3 
    The necessary raw materials are obtained, transferred to correct manufacturing areas and verified as being correct. 

    ASSESSMENT CRITERION 4 
    The necessary packaging containers are obtained (if required) and appropriately labelled. 
    ASSESSMENT CRITERION RANGE 
    The necessary packaging containers include those specific to rejects, bulk, container x of y.
     

    ASSESSMENT CRITERION 5 
    Relevant documents are completed according to organisational procedure. 
    ASSESSMENT CRITERION RANGE 
    Relevant documents include records, logs, area status.
     

    SPECIFIC OUTCOME 2 
    Manufacture a product according to the Process Instruction (PI). 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The necessary in-process checks are conducted and results are recorded. 

    ASSESSMENT CRITERION 2 
    Deviations are identified and reported to the appropriately authorised person. 

    ASSESSMENT CRITERION 3 
    Corrective action is taken according to instructions. 

    ASSESSMENT CRITERION 4 
    Necessary samples are taken and labelled as required. 

    ASSESSMENT CRITERION 5 
    The documentation is completed according to organisational procedure. 

    SPECIFIC OUTCOME 3 
    Shut-down the production process. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    All pharmaceutical products are removed from the manufacture area. 
    ASSESSMENT CRITERION RANGE 
    Pharmaceutical products include waste which needs to be disposed of correctly; labelled bulk containers retuned to the bulk store.
     

    ASSESSMENT CRITERION 2 
    The equipment and manufacture area are cleaned according to standard operating procedure. 

    ASSESSMENT CRITERION 3 
    Machinery and equipment records and/or logs are completed including status labelling of the area. 

    ASSESSMENT CRITERION 4 
    Completion of the Process Instruction according to the actual process conducted is verified. 

    ASSESSMENT CRITERION 5 
    The product is reconciled according to the SOP. 

    ASSESSMENT CRITERION 6 
    The completed Process Instruction is returned to the authorised personnel. 


    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:
  • Process Instruction.
  • Scope of Practice.
  • Starting materials.
  • Sampling procedures.
  • Appropriately authorised personnel.
  • Critical points in manufacturing processes.
  • Deviations.
  • Equipment Logbooks. 

  • 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 all Specific Outcomes. 

    UNIT STANDARD CCFO ORGANISING 
    Organise oneself and ones activities.

    Refer all Specific Outcomes. 

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

    Refer all Specific Outcomes. 

    UNIT STANDARD CCFO COMMUNICATING 
    Communicate effectively.

    Refer to the following Specific Outcomes:
  • Prepare for production process.
  • Manufacture a product according to the Process Instruction (PI). 

  • UNIT STANDARD CCFO SCIENCE 
    Use science and technology.

    Refer all Specific Outcomes. 

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

    Refer 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 
    Authorised Approval is obtained where required in accordance with regulatory requirements and company SOP's. 

    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  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.