NorthWest Biotherapeutics Inc (NWBO)

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During the approval process for new marketing applications, the FDA conducts inspections and assessments of all facilities (worldwide) wherever a drug is manufactured, processed, and packaged to determine a drug manufacturers’ compliance with CGMPs, applicable laws and regulations, and to determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market. There are Mutual Recognition Agreements (MRAs) between the FDA and foreign regulatory authorities which allow drug inspectors to rely upon information from drug inspections conducted within each other’s borders, however, Advanced Therapy Medicinal Products (ATMPs) are excluded from the scope.

Facts About the Current Good Manufacturing Practices (CGMPs)

https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps