The bioprocessing industry is governed by cGxP Whether performed internally by the component manufacturer or through an external contract research organization (CRO), any data that are used to make quality decisions must meet minimum data integrity and traceability standards and are expected to be under oversight of a quality management system. It is the expectation of BioPhorum member companies that data provided by suppliers is generated in such a way as to be compliant with these standards. While it is not necessary for data to be generated to cGxP, it is expected that the component manufacturer (i.e. study sponsor) takes ownership of the study design and review of the data. Typically, this will require technical functional area input and oversight from the supplier’s Quality Unit.
For clarity, where a third party (such as a CRO) has performed extractables testing, it is not sufficient for its report to simply be passed along to the end-user. Information related to the specific component tested and study design should be reported in the standard BioPhorum Extractables Data Summary (BEDS) format and be under control of the component manufacturer’s quality management system.