Elements and Performance Criteria
- Elements define the essential outcomes
- Source informationon formula
- Prepare for production process
- Confirm the availability of the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator required to compound the product according to the work sheet
- Comply with dress code, safety and personal hygiene procedures prior to entering the work area
- Clean work area and equipment correctly
- Maintain inventory levels of materials and disposable equipment
- Prepare a work sheet referenced from amaster work sheet
- Assign product batch number
- Verify that the work sheets are clearly written in logical order with clear directions and contain all the required information
- Generate the product labels referenced from the master label detailed on the master work sheet
- Check and note the number of labels generated
- Submit work sheet and labels to pharmacist for approval
- Check and set up compounding requirements and disposable equipment
- Obtain equipment and supplies
- Assemble materials used in aseptic compounding as listed in the work sheet, 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
- Select appropriate types, size and features of containers and packaging listed in the work sheet
- Weigh or measure materials in designated area
- Obtain required authorisation or checks at designated points according to the work sheet
- Prepare for sterile manufacturing
- Prepare for cytotoxic production
- Compound products using aseptic techniques
- Allocate approved bulk materials, intermediary products and containers to appropriate equipment
- Incorporate materials according to work sheet using appropriate manipulation technique
- Compound product according to method on manufacturing work sheet
- Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs
- Operate specialist equipment and use specialist supplies in sterile production preparation
- 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 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 report discrepancies to the pharmacist
- Place product in quarantinearea under appropriate storage conditions
- Clean machinery and manufacturing area and dispose of disposable equipment safely
- Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs
- Complete required documentation and forward to an authorised person
- Report discrepancies to an authorised person
- Obtain final approval from pharmacist before releasing compounded medicines to storage areas
- Discard waste materials appropriately
- 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
- Record and file product quality control assay results and manufacturing area environmental monitoring results
- Store and transport released product
- Store products according to the work sheet
- 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