What are the regulations pertaining to the production of pharmaceuticals?

In North Carolina, there are several regulations that must be followed for the production of pharmaceuticals. The first regulation is that any person or company that produces pharmaceuticals must be licensed by the North Carolina Board of Pharmacy. This board can issue a privilege to the applicant that allows them to compound, dispense, and sell drugs as well as other services related to drug production. The license is required to be renewed every two years. The second regulation is that all pharmaceuticals must be manufactured under the direction of a licensed pharmacist. This ensures the safety and quality of the products are maintained. The third regulation is that the manufacture of pharmaceuticals must be done in a clean and safe environment. The manufacturing area must have adequate ventilation, temperature control, and surface finishes. The fourth regulation is that all pharmaceuticals must be manufactured in accordance with Good Manufacturing Practice (GMP) standards. This is an international standard set by the World Health Organization and regulated by the U.S. Food and Drug Administration (FDA). GMP requires that pharmaceuticals must meet the highest standards for purity, potency, and safety. The fifth regulation is that all pharmaceutical production must be done under the direction and supervision of a qualified pharmacist. This pharmacist is responsible for all aspects of the production of the drug, including quality control and documentation. In summary, the regulations pertaining to the production of pharmaceuticals in North Carolina are licensing by the North Carolina Board of Pharmacy, production must be supervised by a licensed pharmacist, the manufacturing area must meet certain standards, and the production must be done according to Good Manufacturing Practices standards.

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What are the regulations pertaining to the production of pharmaceuticals?

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