Approaches to visible particulate control strategy

Visual inspection is integral to the particle control strategy with 100% visual inspection of the drug product formulation utilizing trained personnel, qualified equipment and a robust inspection procedure. Current regulatory and industry guidance is focused on visible particles in sterile parenteral dosage forms and not directly applicable to cell and gene therapies (CGT), which are uniquely characterized by their cellular content, low batch volumes and inability to sterile filter prior to drug product fill. This BioPhorum member survey aimed to gather initial industry benchmarking data and interest in defining an industry position.

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