Designing a Facility with Both Good Manufacturing Practice (GMP) and Biosafety in Mind: Synergies and Conflicts

Abstract

Designing a large-scale GMP production facility for biological production requires various types of risk assessments to be carried out. This is the main tool in obtaining a balance between the aspects where GMP and biosafety guidelines contradict each other. Only by evaluating the various risks involved in the project, can rational and optimal choices be made regarding facility design and construction.

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