Introduction to Regulatory Resources

Global government agencies oversee select industries to confirm manufacturers follow regulations designed for consumer safety. Food processing facilities, dairy farms, vaccine and drug manufacturers, and blood banks are among those industries inspected to protect consumers from unsafe products (FDA, 2021). The pharmaceutical and biotechnology industries produce life-saving drug products for “use in the diagnosis, cure, mitigation, treatment, or prevention of disease” (FDA, 2021). These industries control manufacturing and cleaning processes to the highest level to ensure the health and safety of consumers.

Government regulatory agencies and industry organizations develop guidelines to ensure pharmaceutical and biotechnology manufacturers have robust cleaning processes. This article will provide an overview of resources related to cleaning validation in the pharmaceutical and biotechnology industries.

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