Elements and Performance Criteria
- Source information on formula
- Select appropriate dosage form for product, based on client need and/or against order for 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
- 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 raw 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 equipment
- Obtain and process raw materials
- Acquire all materials listed on the worksheet according to stock levels and stock requisitioning procedures
- Check raw materials to ensure they have been released from quarantine for use by authorised persons
- Verify raw materials against manufacturing work sheet and record raw material batch numbers and expiry dates
- Weigh or measure raw materials in designated area
- Obtain required authorisation or checks at designated points according to work sheet
- Compound products
- Allocate approved raw materials to equipment according to batch documentation
- Compound product according to method on work sheet
- Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications
- Perform verification procedures, 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
- Clean machinery and manufacturing area and dispose of disposable equipment safely
- Complete all required documentation and forward to an authorised person
- Report all discrepancies to an authorised person
- Obtain final approval from the pharmacist before releasing packed medicines to storage areas
- Participate in quality control
- Store and transport released 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
- Advise receipting area personnel of specific storage requirements
- Complete and file records and/or work sheets