ELEMENT

PERFORMANCE CRITERIA

1. Prepare tor production process

1.1 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

1.2 Confirm relevant legal, quality and hospital policy factors in sterile production

1.3 Follow correct dress code, safety and personal hygiene procedures and Personal Protective Equipment (PPE)

1.4 Maintain preparation areas at NCCTG requirements and Australian Standards for area classification

1.5 Clean work area and equipment correctly

1.6 Maintain inventory levels of materials and disposable equipment

1.7 Obtain and clarify the confirmed and formulated manufacturing order from pharmacist

1.8 Prepare production work sheet from formulated manufacturing order/master batch sheet

1.9 Interpret manufacture work sheet and assign appropriate product batch number

1.10 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)

1.11 Prepare labels and check number of labels generated

2. Prepare for cytotoxic production

2.1 Apply an understanding of cytotoxic drugs and their basic pharmacology to the preparation of products

2.2 Apply an understanding of SHPA Standards for preparation of cytotoxic drugs and relevant State legislation

2.3 Make cytotoxic spill cleaning kits available in all production areas

2.4 Use specialist equipment and clothing for the safe handling and preparation of cytotoxic drugs

2.5 Identify exposure hazards and mitigation requirements related to cytotoxic drugs

3. Obtain equipment, consumables, containers required for manufacturing process

3.1 Acquire all materials used in aseptic production according to stock levels and stock requisitioning procedures

3.2 Check materials to ensure they have been released from quarantine for use by authorised persons

3.3 Verify materials against manufacturing work sheet and record material batch numbers

3.4 Weigh and measure materials in designated weighing area

3.5 Allocate raw materials to appropriate manufacturing machinery, where applicable

3.6 Select appropriate types, size and features of containers and packaging in sterile manufacturing

3.7 Obtain appropriate authorisation/checks at designated points

4. Prepare for sterile manufacturing

4.1 Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area

4.2 Follow hand washing, gowning and appropriate gloving procedures

4.3 Disinfect and transfer materials, disposable equipment and work sheet to sterile production area

5. Manufacture/compound products using aseptic techniques

5.1 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

5.2 Allocate approved bulk materials, intermediary products and containers to appropriate machinery / equipment where required

5.3 Incorporate materials according to batch documentation

5.4 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

5.5 Prepare cytotoxic products using procedures for handling cytotoxic drugs.

5.6 Work within the requirements of sterile areas, air locks, laminar flow hoods and cytotoxic drug safety cabinet / isolator

5.7 Operate specialist equipment and use specialist supplies in sterile production preparation

5.8 Obtain required authorisation/checks at designated points

5.9 Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications

5.10 Perform checking procedure and inspect finished product for deviations

5.11 Pack product using appropriate packaging devices/machinery as specified on the work sheet, and following approval from an authorised person

5.12 Label containers/units according to labelling specifications on the work sheet

5.13 Pack and label a retention sample and/or quality control sample if specified on the work sheet

6. Complete production process

6.1 Place product in quarantine area under appropriate storage conditions, where specified

6.2 Clean machinery and manufacturing area

6.3 Identify procedures for cleaning cytotoxic spills and the course of action taken after accidental contact with cytotoxic drugs and their safe disposal

6.4 Complete machinery and equipment records and/or logs

6.5 Reconcile the number of labels printed with the number used and discard excess. Note discrepancies in labels and documentation

6.6 Complete documentation and forward to appropriate person

6.7 Report discrepancies to an authorised person

6.8 Obtain final clearance from an authorised person

7. Participate in quality control

7.1 Perform environmental monitoring according to organisation requirements and report abnormal readings to an authorised person

7.2 Submit product sample and relevant documentation to quality control, where specified

7.3 Record and file product quality control assay results and manufacturing area environmental monitoring results

8. Transport and store release product

8.1 Store products according to manufacturing documentation

8.2 Obtain released product(s) from quarantine store

8.3 Pack released product(s) into appropriate delivery containers

8.4 Deliver product to store/dispensary by appropriate means, ensuring safe transport of cytotoxic products

8.5 Advise receipting area personnel of any special storage requirements

8.6 Complete and file records and/or work sheets