The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!
From the Wiki University
What evidence can you provide to prove your understanding of each of the following citeria?
Prepare tor production process
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Identify the circumstances that require compounding of the product within a laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator Completed |
Evidence:
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Confirm relevant legal, quality and hospital policy factors in sterile production Completed |
Evidence:
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Follow correct dress code, safety and personal hygiene procedures and Personal Protective Equipment (PPE) Completed |
Evidence:
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Maintain preparation areas at NCCTG requirements and Australian Standards for area classification Completed |
Evidence:
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Clean work area and equipment correctly Completed |
Evidence:
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Maintain inventory levels of materials and disposable equipment Completed |
Evidence:
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Obtain and clarify the confirmed and formulated manufacturing order from pharmacist Completed |
Evidence:
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Prepare production work sheet from formulated manufacturing order/master batch sheet Completed |
Evidence:
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Interpret manufacture work sheet and assign appropriate product batch number Completed |
Evidence:
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Check and set up compounding machinery or disposable equipment and any specialist equipment and clothing required for the compounding of sterile pharmaceutical products (e.g. cytotoxic spill cleaning kits) Completed |
Evidence:
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Prepare labels and check number of labels generated Completed |
Evidence:
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Prepare for cytotoxic production
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Apply an understanding of cytotoxic drugs and their basic pharmacology to the preparation of products Completed |
Evidence:
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Apply an understanding of SHPA Standards for preparation of cytotoxic drugs and relevant State legislation Completed |
Evidence:
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Make cytotoxic spill cleaning kits available in all production areas Completed |
Evidence:
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Use specialist equipment and clothing for the safe handling and preparation of cytotoxic drugs Completed |
Evidence:
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Identify exposure hazards and mitigation requirements related to cytotoxic drugs Completed |
Evidence:
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Obtain equipment, consumables, containers required for manufacturing process
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Acquire all materials used in aseptic production according to stock levels and stock requisitioning procedures Completed |
Evidence:
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Check materials to ensure they have been released from quarantine for use by authorised persons Completed |
Evidence:
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Verify materials against manufacturing work sheet and record material batch numbers Completed |
Evidence:
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Weigh and measure materials in designated weighing area Completed |
Evidence:
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Allocate raw materials to appropriate manufacturing machinery, where applicable Completed |
Evidence:
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Select appropriate types, size and features of containers and packaging in sterile manufacturing Completed |
Evidence:
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Obtain appropriate authorisation/checks at designated points Completed |
Evidence:
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Prepare for sterile manufacturing
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Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area Completed |
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Follow hand washing, gowning and appropriate gloving procedures Completed |
Evidence:
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Disinfect and transfer materials, disposable equipment and work sheet to sterile production area Completed |
Evidence:
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Manufacture/compound products using aseptic techniques
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Comply with NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals and Australian Standards for operator safety when cleaning, setting up work station and transference of materials Completed |
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Allocate approved bulk materials, intermediary products and containers to appropriate machinery / equipment where required Completed |
Evidence:
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Incorporate materials according to batch documentation Completed |
Evidence:
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Compound product according to method on manufacturing work sheet (e.g. aseptically transfer materials from one vessel to another) and in compliance with standard operating procedures for any measuring device or machinery use Completed |
Evidence:
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Prepare cytotoxic products using procedures for handling cytotoxic drugs. Completed |
Evidence:
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Work within the requirements of sterile areas, air locks, laminar flow hoods and cytotoxic drug safety cabinet / isolator Completed |
Evidence:
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Operate specialist equipment and use specialist supplies in sterile production preparation Completed |
Evidence:
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Obtain required authorisation/checks at designated points Completed |
Evidence:
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Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications Completed |
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Perform checking procedure and inspect finished product for deviations Completed |
Evidence:
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Pack product using appropriate packaging devices/machinery as specified on the work sheet, and following approval from an authorised person Completed |
Evidence:
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Label containers/units according to labelling specifications on the work sheet Completed |
Evidence:
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Pack and label a retention sample and/or quality control sample if specified on the work sheet Completed |
Evidence:
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Complete production process
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Place product in quarantine area under appropriate storage conditions, where specified Completed |
Evidence:
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Clean machinery and manufacturing area Completed |
Evidence:
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Identify procedures for cleaning cytotoxic spills and the course of action taken after accidental contact with cytotoxic drugs and their safe disposal Completed |
Evidence:
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Complete machinery and equipment records and/or logs Completed |
Evidence:
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Reconcile the number of labels printed with the number used and discard excess. Note discrepancies in labels and documentation Completed |
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Complete documentation and forward to appropriate person Completed |
Evidence:
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Report discrepancies to an authorised person Completed |
Evidence:
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Obtain final clearance from an authorised person Completed |
Evidence:
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Participate in quality control
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Perform environmental monitoring according to organisation requirements and report abnormal readings to an authorised person Completed |
Evidence:
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Submit product sample and relevant documentation to quality control, where specified Completed |
Evidence:
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Record and file product quality control assay results and manufacturing area environmental monitoring results Completed |
Evidence:
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Transport and store release product
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Store products according to manufacturing documentation Completed |
Evidence:
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Obtain released product(s) from quarantine store Completed |
Evidence:
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Pack released product(s) into appropriate delivery containers Completed |
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Deliver product to store/dispensary by appropriate means, ensuring safe transport of cytotoxic products Completed |
Evidence:
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Advise receipting area personnel of any special storage requirements Completed |
Evidence:
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Complete and file records and/or work sheets Completed |
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