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Re: Responses to the BBR Audit of Saskatoon Centre 07 - 11 May 2001


Re: Responses to the BBR Audit of Saskatoon Centre 07 - 11 May 2001

The following are the actions undertaken by the Saskatoon Centre and Head Office in response to the observations contained in the Bureau of Biologics and Radiopharmaceuticals Exit Notice.

Manufacturing control - C.02.011

Apheresis platelets that have a "measure platelet and WBC content of this product" COBE message are issued prior to having a WBC count performed. The product is labeled as leukoreduced and there is no label on the component to identify it as non-conforming although a letter is sent to the hospital blood bank with the unit.

A COP will be developed by 2001-07-31 to include instructions to place a tag identifying the plateletpheresis unit as non-conforming.

Manufacturing control/ - C.02.011

A component had an incorrect Rh label applied during sort and the error was caught by the sort verification process. There is no written procedure describing the re-labeling of units that have been mislabeled.

A Change request will be submitted to CCU by 2001-06-29 to provide instructions describing the re-labeling of units that have been mislabeled and the error is caught during the sort verification process.

Manufacturing control - C.02.011

There is no documentation of the parameters used for the sample preparation centrifuges.

A Change Request was discussed by CCU on 2001-03-06 to require the documentation of parameters used for the centrifugation of samples for laboratory testing. It was deferred until a study is completed regarding the impact of these changes to the current process. The study is ongoing and upon completion the working group's recommendations will be presented to CCU. An update will be forwarded when CCU has made a decision.

Manufacturing control - C.02.011

There is no written procedure requiring NAT samples to be counted to ensure only 20-108 samples are packed per honeycomb tray for transport.

The written procedure requiring samples to be counted to ensure only 20 - 108 samples are packed is not required since the packing configuration and the number of samples to be packed is already outlined in SOP 01 151 work instruction 2.3 and Figure 1.

Manufacturing control - C.02.011

The practice of counting the number of labels required for each batch prior to production is not written operating procedure.

COP CP:200 will be revised by 2001-08-31 to include instruction indicating that during the batching process the correct number of labels required for each batch should be counted out and attached to the appropriate batch sheet.

Manufacturing control - C.02.011

Sterile glove lot numbers and expiry dates were not documented and linked to collections.

A change request will be submitted to the Change Control Unit by 2001-06-15 to address the observation of documenting lot numbers and expiry dates of sterile gloves.

Manufacturing control - C.02.011

The process of using an internet site to determine the temperature at the shipping site, in order to pack in the appropriate configuration as per D96 083, is not in a written operating procedure.

TC:110 "Packing Whole Blood and Red Cells" will be revised by 2001-07-31 to include instructions of how to determine the temperature at the shipping site in order to pack in the appropriate configuration as per D96-083.

Manufacturing control - C.02.011

Some BLIS request forms were not completed as per CS 07821, in that the modules not required were not checked in the "N" column.

Those staff requiring training to the completion of the BLIS Request Form will be identified and training will be provided by 2001-06-15.

Manufacturing control - C.02.011

There is not written procedure to ensure that BLIS modules are removed from users that have had a deactivation request submitted to Head Office.

A COP will be developed and implemented by 2001-07-16 to provide instructions on the removal of BLIS modules at the Centre when the users have had a deactivation request submitted to Head Office.

Manufacturing control - C.02.011

A shipment of components packed in 2 separate boxes were not marked "1 of 2", "2 of 2" as per COP TC: 110, section 4.6.2.

TC:110,"Packing Whole Blood and Red Cells", will be revised by 2001-07-31 to clarify that the documentation must happen for in-town and out of town shipments.

Manufacturing control - C.02.0115

The limits range for the Cell and Cup A on F040671 do not match those identified in Figure 1 of SOP 27 069.

A meeting was held to discuss post implementation issues for the Olylmpus PK instruments. The issue identified in the observation was also identified during the meeting. Form F040671 will be updated with the Olympus PK instrument post implementation revisions and will be submitted to the Bureau by 2001-09-01.