Elements and Performance Criteria
- Source information on formula
- Select appropriate dosage form for product, based on client need and/or against application of medicine
- Use validated resources to source available formulae for required product
- Consolidate and make relevant information available
- Confirm suitability of chosen formula and availability of resources
- Obtain authority of pharmacist to proceed
- Obtain and clarify the confirmed and formulated manufacturing order or master batch sheet from pharmacist, when required
- Prepare for production process
- 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
- Clean work area and equipment correctly
- Maintain inventory levels of materials and disposable equipment
- Prepare a batch/work sheet referenced from a master sheet or formulae
- Assign product batch number, if required
- Verify that batch/work sheets are clearly written in logical order with clear directions and contain all the required information
- Generate the product labels referenced from a master label
- Check and note the number of labels generated
- Submit batch/work sheet and labels to pharmacist for approval
- Check and set up compounding machinery or disposable equipment
- Obtain equipment, consumables, containers required for manufacturing process
- Acquire all materials used in aseptic production according to stock levels and stock requisitioning procedures
- Check materials to ensure they have been released from quarantine for use by authorised persons
- Verify materials against manufacturing work sheet and record material batch numbers and expiry dates
- Weigh or measure materials in designated area
- Select appropriate types, size and features of containers and packaging in sterile manufacturing
- Obtain required authorisation or checks at designated points
- Prepare for sterile manufacturing
- Prepare for cytotoxic production
- Compound products using correct aseptic techniques
- Allocate approved bulk materials, intermediary products and containers to appropriate machinery / equipment where required
- Incorporate materials according to batch documentation
- Compound product according to method on manufacturing work sheet
- Prepare cytotoxic products using procedures for handling cytotoxic drugs
- Operate specialist equipment and use specialist supplies in sterile production preparation
- Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications
- Perform verification procedures and inspect finished product for deviations and report to authorised person
- Pack compounded product into appropriate container as specified on the work sheet, and following approval from an authorised person
- Label containers/units according to labelling specifications on the work sheet
- Obtain required authorisation or checks at designated points
- Complete production process
- Reconcile the number of labels printed with number used and discard excess, noting and documenting discrepancies in labels
- Place product in quarantinearea under appropriate storage conditions, where specified
- Clean machinery and manufacturing area and dispose of disposable equipment safely
- Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs
- Complete all required documentation and forward to an authorised person
- Report discrepancies to an authorised person
- Obtain final approval from the pharmacist before releasing packed medicines to storage areas
- Participate in quality control
- Pack and label a retention sample and/or quality control sample if specified on the work sheet
- Perform environmental monitoring and report abnormal readings to an authorised person
- Submit product sample and relevant documentation to quality control, where specified
- Record and file product quality control assay results and manufacturing area environmental monitoring results
- Transport and store release product
- Store products according to manufacturing documentation
- Obtain released product(s) from quarantine store
- Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product
- Deliver product to destination ensuring safe transport of cytotoxic products
- Advise receipting area personnel of storage requirements
- Complete and file records and/or work sheets