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?
Source information on formula
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Select appropriate dosage form for product, based on client need and/or against application of medicine Completed |
Evidence:
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Use validated resources to source available formulae for required product Completed |
Evidence:
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Consolidate and make relevant information available Completed |
Evidence:
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Confirm suitability of chosen formula and availability of resources Completed |
Evidence:
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Obtain authority of pharmacist to proceed Completed |
Evidence:
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Obtain and clarify the confirmed and formulated manufacturing order or master batch sheet from pharmacist, when required Completed |
Evidence:
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Prepare for production process
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Confirm the need to use the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator to compound the product 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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Prepare a batch/work sheet referenced from a master sheet or formulae Completed |
Evidence:
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Assign product batch number, if required Completed |
Evidence:
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Verify that batch/work sheets are clearly written in logical order with clear directions and contain all the required information Completed |
Evidence:
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Generate the product labels referenced from a master label Completed |
Evidence:
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Check and note the number of labels generated Completed |
Evidence:
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Submit batch/work sheet and labels to pharmacist for approval Completed |
Evidence:
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Check and set up compounding machinery or disposable equipment 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 and expiry dates Completed |
Evidence:
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Weigh or measure materials in designated area 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 required authorisation or 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 |
Evidence:
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Follow hand washing, gowning and 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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Prepare for cytotoxic production
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Check that cytotoxic spill cleaning kits are available in all production areas Completed |
Evidence:
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Select and use specialist equipment and clothing for the safe handling and preparation of cytotoxic drugs Completed |
Evidence:
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Follow specific procedures to minimise risk of exposure to cytotoxic drugs Completed |
Evidence:
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Compound products using correct aseptic techniques
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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 Completed |
Evidence:
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Prepare cytotoxic products using procedures for handling cytotoxic drugs Completed |
Evidence:
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Operate specialist equipment and use specialist supplies in sterile production preparation Completed |
Evidence:
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Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications Completed |
Evidence:
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Perform verification procedures and inspect finished product for deviations and report to authorised person Completed |
Evidence:
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Pack compounded product into appropriate container 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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Obtain required authorisation or checks at designated points Completed |
Evidence:
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Complete production process
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Reconcile the number of labels printed with number used and discard excess, noting and documenting discrepancies in labels Completed |
Evidence:
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Place product in quarantinearea under appropriate storage conditions, where specified Completed |
Evidence:
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Clean machinery and manufacturing area and dispose of disposable equipment safely Completed |
Evidence:
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Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs Completed |
Evidence:
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Complete all required documentation and forward to an authorised person Completed |
Evidence:
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Report discrepancies to an authorised person Completed |
Evidence:
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Obtain final approval from the pharmacist before releasing packed medicines to storage areas Completed |
Evidence:
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Participate in quality control
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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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Perform environmental monitoring 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 delivery containers which will maintain the required ambient conditions for the product Completed |
Evidence:
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Deliver product to destination ensuring safe transport of cytotoxic products Completed |
Evidence:
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Advise receipting area personnel of storage requirements Completed |
Evidence:
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Complete and file records and/or work sheets Completed |
Evidence:
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