Data management in the cell therapy production facility: the batch process record (BPR).

Abstract

The activities of cell therapy establishments are associated with substantial amounts of information. For reasons of best practice, regulation and adherence to prevailing standards, the data generated in the course of cell therapy product processing must be recorded and retained in an organized manner. Because cell therapy products are functionally pharmaceuticals, the paradigm of the pharmaceutical manufacturing batch process record (BPR) is proposed as a unit for collecting the data resulting from processing. Considerations for cell-processing facilities for the design of BPR and possible selection of electronic data-recording tools are reviewed, including data to collect in response to regulatory or accreditation mandates and different types of electronic data management tools that may be employed. Additionally, considerations for selection, qualification and validation of computer software for maintenance of the BPR are addressed.