Environmental monitoring in drug product (EMinDP)

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Why applying environmental monitoring best practices will reap benefits for all

Why applying environmental monitoring best practices will reap benefits for all

Environmental monitoring (EM) programs are an effective tool in assessing the state of control in classified manufacturing areas. They are a vital part of the quality system in all modern drug production facilities and are scrutinized by regulatory agencies. However, designing an EM program is a relatively complex task; facilities vary considerably, there is inadequate specific guidance on how to design one and no single standard risk...

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