Guide for the Assessment of Clotting Factor Concentrates

(E) BLOOD/PLASMA SCREENINGScreening test Name of kit – manufacturer Regulatory status (USA/Europe)HbsAgHCV antibodyHIV antibodyHCV NAT (if any)HIV NAT (if any)(F) QUALITY ASSURANCE OF TEST KITSDescribe any internal and external QA used by the collection agencies for their screening tests(G) PLASMA MEASURES BY MANUFACTURERAny inventory hold measures, etc. Maximum number of Testing of the Estimate of viral load in plasma pooldonations in plasma pool plasma pool – from viral incidence dataserology, NAT,etc.HIV HCV HBV2) MANUFACTURING PROCESSThe manufacturer is to include a copy of the licence to manufacture issued by the country where the facility is located andany other authority(A) CRITICAL STEPSHere insert a flow chart of the manufacturing process, identify the crucial manufacturing steps and list their relatedin-process controls (IPCs)(B) VIRAL REDUCTIONList dedicated viral reduction stepsValidated log 10 elimination for1. HIV (actual virus)2. HCV (specify model, e.g., BVDV, etc.)3. HBV (specify model)4. HAV (actual virus or specify model)5. Parvovirus B19 (specify model)Estimated residual risk per vial of product from plasma poolviral load and validated viral elimination data, for1. HIV2. HCV3. HBV(C) PROCESS CONSISTENCYList in-process controls (IPCs) identified in 2(a) for three chronologically sequential batches of the product manufacturedat the scale used for the marketed form manufactured within the last 18 months.In-process controls Batch – 01 Batch – 02 Batch – 03IPC-1IPC-2IPC-3IPC-4IPC-544 Guide for the Assessment of Clotting Factor Concentrates