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    Non-sterile manufacturing

    Non-sterile manufacturing refers to drug production methods which do not completely eliminate potential contaminants. Depending on the item being manufactured, procedures are designed to control the burden of contamination to a safe level, without enduring the added time and expense to eliminate the burden of contamination. Factors specific to the drug's activity, target patient population, and route of administration are considered when determining standards for non-sterile manufacturing procedures.

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