A recent event of “Watered Down Chemo Drugs given to 1,200 cancer patients” in Ontario and New Brunswick was the result of adding too much saline to a product thus diluting the active drug by up to 20%. The problem was detected visually by a pharmacy technician in one of the affected hospitals.
This issue could have easily been detected by the supplier by implementing adequate fill weight checks on the products concerned. A statement from the manufacturer stated “Our preliminary investigation of this issue leads us to be confident that we have met the quality specifications of the contract”.
It is important to have clear and concise specifications as well as proper testing at the manufacturing stage,as well as acceptance testing as products are received at the customer site.
Lack of proper monitoring of product fill weights can be a medical nightmare, as noted above, but can also be costly in terms of money and efficiencies. Overfilling to ensure meeting regulatory requirements can also be very costly in terms of product costs as well as added transportation related costs due to added weights.
Once of our sample applications that comes with the Quality Window 5 product is designed for monitoring Fill Weights. By setting proper specification and target limits as well as the setting of control rules along with the calculation of costs for under and over fill values ensures tight control on this very critical stage in the manufacturing process.