Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes:Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)

摘要

Three major concerns predominate biotechnology executive management in organizations of all sizes and above all other risks: finance (or its absence at critical moments), technological performance, and failures in coordination. Some business functions, such as human resources (HR), are effectively siloed horizontally and therein are more likely to be susceptible to only one of those risks (l). Few functions are subject to this trinity of risks simultaneously; all functions may be exposed to failuresin internal coordination, and a smaller subset can be prey to challenges of both internal and external coordination. But manufacturing can be exposed to all three concerns (2).