UK strategy for process qualification/validation: from concept to practical implementation.
In this communication, after a brief review of current requirements of various stages of leucodepletion qualification/validation processes, we provide some practical examples for the usefulness of long term validation programme for process improvement. It is hoped that the experience gained from this process qualification/validation enhances the awareness to key variables that can influence the overall outcome of filtration programme.
Beckman
N
N
UK National Blood Service London & South East, Diagnostic, Development and Research Directorate, UK.
Seghatchian
J
J
D020811:Biomedical Technology; D001781:Blood Component Removal / Q000592:standards*; D003257:Consumer Product Safety; D005069:Evaluation Studies as Topic; D006801:Humans; D007962:Leukocytes; D011786:Quality Control; D006113:United Kingdom