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: 

Weigh raw materials in large scale pharmaceutical manufacturing 
SAQA US ID UNIT STANDARD TITLE
256483  Weigh raw materials in 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 
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 are required to deal with raw materials in large-scale manufacturing. Individuals credited with this standard will be able to complete all procedures pertinent to the weighing of raw materials. They will also be able to weigh and measure raw materials accurately. 

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 Standard:
    > 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 the weighing of raw materials. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Orders requesting the weighing of raw material are received, read and checked against a schedule. 

    ASSESSMENT CRITERION 2 
    Palletised raw materials and labels are obtained and verified to the batch documentation. 

    ASSESSMENT CRITERION 3 
    The equipment appropriate to the weighing of the raw material is identified and ensured to be available. 
    ASSESSMENT CRITERION RANGE 
    Equipment includes weighing tools, packaging material, and scale.
     

    ASSESSMENT CRITERION 4 
    Hygiene and safety requirements are identified and adhered to at all times. 

    ASSESSMENT CRITERION 5 
    The appropriate personal protective equipment is selected and used at all times. 

    ASSESSMENT CRITERION 6 
    Appropriate documents are completed and relevant authorisation to proceed is obtained according to organisational procedures and policy. 

    SPECIFIC OUTCOME 2 
    Weigh raw materials. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The order in which ingredients are safely weighed is explained, focussing on the problems associated with working out of sequence. 

    ASSESSMENT CRITERION 2 
    Materials are accurately weighed and measured according to the formula. 
    ASSESSMENT CRITERION RANGE 
    Weighing includes tare weight; gross weight; nett weight.
     

    ASSESSMENT CRITERION 3 
    The pallet label is completed in accordance with batch documentation and correctly attached to pallet. 

    ASSESSMENT CRITERION 4 
    Materials are labelled and palleted in accordance with the batch documentation. 

    ASSESSMENT CRITERION 5 
    Appropriate documents are completed and relevant authorisation to proceed is obtained. 

    SPECIFIC OUTCOME 3 
    Conclude the weighing process. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Weighed raw materials are transferred to appropriate transit areas in accordance with the standard operating procedures. 

    ASSESSMENT CRITERION 2 
    Unused raw materials are returned to the appropriate storage areas in accordance with the standard operating procedures. 

    ASSESSMENT CRITERION 3 
    The weighing area is cleaned in accordance with the standard operating procedures. 

    ASSESSMENT CRITERION 4 
    Equipment is cleaned and stored in accordance with the standard operating procedure. 

    ASSESSMENT CRITERION 5 
    Unused packaging and labels are destroyed according to instruction from the appropriately authorised persons. 

    ASSESSMENT CRITERION 6 
    Documents are completed according to standard operating procedure. 


    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:
  • Raw material.
  • Regulatory requirements.
  • Product traceability. 

  • 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 ORGANISING 
    Organise oneself and ones activities:

    Refer to all Specific Outcomes. 

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

    Refer to the following Specific Outcom(s):
  • Prepare for the weighing of raw materials.
  • Weigh raw materials. 

  • 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 the following Specific Outcome(s):
  • Prepare for the weighing of raw materials.
  • Weigh raw materials. 

  • 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  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.