Assessing Potent Compound Safety Capabilities at CMOs

The safe manufacture of potent active pharmaceutical ingredients (APIs) and products containing these APIs requires both "hardware" -- facility features, modern equipment and engineering controls -- and "software" -- programs, practices and procedures -- to adequately protect personnel and the environment. When outsourcing pharmaceutical production to third party contract manufacturing organizations (CMOs), their technical capability to meet clinical or commercial requirements is only one aspect that needs to be evaluated. There is also a need to ensure, with the same rigor, that these CMOs are capable of safely handling potent APIs and products.

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