Microbiology FDA 483 (Samsung Biologics): Controls over manufacturing operations and process have not been adequately established
Observation
Facility Type
Firm / Company
Samsung Biologics Co. Ltd.
System
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Specifically,
(A) Airflow visualization studies have not been performed for all interventions as required by procedure: SOP-MFP-00206, “Airflow Visualization Evaluation”, Version; 8,0, Effective Date; 26-Juoe-2023. The removal of the jammed vials at the *** and the removal, adjustment/maintenance, and re-installation of the ***, have not been evaluated as part of smoke studies.
(B) Fill line *** for *** drug product manufacture includes a *** conveying system, where *** vials filled with drug product can be filled and pending stoppering during a line stoppage. There is no procedure or HMI limitation for how long product filled vials can be exposed to the filling environment pending stoppering nor is there a requirement for a time-period to be assessed by media fill. Your Quality Risk Assessment fails to assess the said condition and impact on product quality.
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FDA 483 relevant to Microbiology
Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.