Tag: <span>risk management</span>

Virtual Biopharmaceutical Sourcing: Six Methods for Six Sigma Outsourcing

Despite trepidations, bioprocess oursourcing has come a long way from its inception, which was born in necessity and regulatory fear. Based on primary research that Seraphim and Pharmsource conducted in 2002, the current market for biopharmaceutical manufacturing outsourcing (upstream and downstream production of bulk APIs, but excluding separately outsourced analytics, development, and other services) was $500 to $700 million with a projection to grow to $1.5 to $2.5 billion over the next five years…

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Biologics Production

bioprocess outsourcing bioprocessing bulk api downstream production intellisourcing risk management six sigma six sigma outsourcing virtual biopharmaceutical sourcing

Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries

An interesting situation occurred ten years ago in an industry where quality had been the critical factor in management decision-making. Quality was abruptly bumped to second place behind pricing, which started a global rush to find lower-cost suppliers and eventually resulted in massive outsourcing. During this evolution, the importance of quality systems for the pharmaceutical and biopharmaceutical community was recognized by regulatory agencies that began establishing risk management standards.

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Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

biologics biopharmaceuticals cgmp fmea GMP iso pharmaceuticals QRM quality risk management risk analysis risk evaluation risk management