DEVIATION BACKGROUND:
On 07/28/2017, During the inspection of PRODUCT A on TP- 18, while the operator was transferring the coated tablets into a plastic scoop, which is used to load the coated tablets into the printer product hopper during the printing, what appeared to be a live and small gnat fly was observed inside the product bag. This was discovered after the operator pulled the product liner off the coated drum to pour the remaining tablets into the scoop.
Per routine procedure, during the printing process in TP18, the operator opens one of the coated tablets drum (no needs to be in sequential number), removes the twist tie from the outer and inner liners and bloused them over, using a plastic scoop transfers the tablets one scoop at the time into the printer hopper until it is full. The printed tablets are then transferred into a labeled and numbered double lined container until 11.5 kg of printed tablets are added or end of batch. The aforementioned process summary is repeated until all of the coated tablets are printed. Note, because the printer product hopper can only be filled scoops at a time due to its allowable quantity/capacity, only container that contained the coated tablets, the printed tablets receiver drum #5 were opened. However, the decision was made to discard all of the printed tablets from container #4 (last filled) and …show more content…
The pest program manages crawling / invading insects through the use of exterior pesticides application and insect monitors throughout the facility. Patheon CRO employs a pest control company (Terminix) that completes the exterior pesticides application for the months of May, July and September every year, while the insect monitoring stations are inspected monthly per SOP
On 07/28/2017, During the inspection of PRODUCT A on TP- 18, while the operator was transferring the coated tablets into a plastic scoop, which is used to load the coated tablets into the printer product hopper during the printing, what appeared to be a live and small gnat fly was observed inside the product bag. This was discovered after the operator pulled the product liner off the coated drum to pour the remaining tablets into the scoop.
Per routine procedure, during the printing process in TP18, the operator opens one of the coated tablets drum (no needs to be in sequential number), removes the twist tie from the outer and inner liners and bloused them over, using a plastic scoop transfers the tablets one scoop at the time into the printer hopper until it is full. The printed tablets are then transferred into a labeled and numbered double lined container until 11.5 kg of printed tablets are added or end of batch. The aforementioned process summary is repeated until all of the coated tablets are printed. Note, because the printer product hopper can only be filled scoops at a time due to its allowable quantity/capacity, only container that contained the coated tablets, the printed tablets receiver drum #5 were opened. However, the decision was made to discard all of the printed tablets from container #4 (last filled) and …show more content…
The pest program manages crawling / invading insects through the use of exterior pesticides application and insect monitors throughout the facility. Patheon CRO employs a pest control company (Terminix) that completes the exterior pesticides application for the months of May, July and September every year, while the insect monitoring stations are inspected monthly per SOP