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GOSH Potential Mixup - Coggle Diagram
GOSH Potential Mixup
Product
Line clearance
- What was the preparation and dispensing sequence of the HIDA-198352 in Tc-Iso1.
- Was HIDA-198352 for GOSH, Wittington & TLC prepared immediately after a Mag-3 dose preparation?
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Diluent (Saline 0.9%)
Did the operator measure the diluent in the syringe prior to drawing up the dose?
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Operator
Product line clearance
Did the operators perform checks to ensure that the large blue work tray is cleared at the end of each line clearance?
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Contaminated material
Could a contaminated needle or syringe have been used by the operator in the product preparation?
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Process
MFR-SOP-002
Did the procedure highlight the following?
- Dispensers in isolators to ensure always that they have the visibility of all the edges of the work tray.
- Production supervisors to check that the work tray is cleared at all times at the end of each line clearances prior to starting the set of dispensing.
- Production supervisors and dispensers to check that a new single needle/syringe is used to perform each sub dispensed multidose vial or syringe dose.
- Production supervisors to ensure that diluent is measured for contamination prior to drawing up the dose from the product stock vial.
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