Biopharmaceutical manufacturing process risks can be described as a network of processes that may include some combination of unit operations, equipment, instruments, control systems, procedures, and personnel practices. The system’s risks can be modelled by a system risk structure (SRS) that describes how threats originate and flow through the network to result in negative consequences (risks). The SRS is a quality risk management (QRM) tool a team of subject matter experts can use to prospectively identify and evaluate a wide variety of risks over the product’s entire development and manufacturing lifecycle. Based on the understanding developed from an SRS analysis, control strategies can be developed by modifying or adding new processes to mitigate the threats, thus reducing the likelihood of the risk consequence being realized. The SRS tool extends the ICH Q9 QRM approach described in a series of articles. Two examples are used to demonstrate how an SRS can be assembled and then used to prospectively identify, understand, and reduce significant risks by controlling the source and flow of threats within the systems described…
Tag: <span>risk</span>
The United States Pharmacopeia (USP) is a 184-year-old organization that has been in the forefront of technology since its inception. From publishing a manual about how to prepare therapeutic potions, USP has evolved into a compendium of standards and information on manufactured pharmaceutical products, with more than 4,000 monographs covering drug substances and biologics, and their dosage forms, excipients, and nutritional supplements. It is not surprising that the USP initiative in cell and gene therapy and tissue engineering has closely followed the emergence of these technologies…