What are the legal requirements for the manufacture of pharmaceuticals?

In Washington, any company that manufactures pharmaceuticals must follow specific legal requirements set forth by the state. The Washington pharmaceutical laws are closely monitored by the Board of Pharmacy, which requires that all manufacturers of drugs must be licensed. Any company wanting to manufacture pharmaceuticals must submit an application to the Board of Pharmacy in order to receive a license. The application must include information about the production site, personnel qualifications and the drugs to be manufactured. Once approved, the manufacturer must adhere to good manufacturing practices. These include requirements for production surfaces and equipment, as well as proper storage of raw materials and finished products. In addition, all personnel involved in the production must have proper safety training, and each drug must be labeled and tested for purity before it can be sold. Finally, all manufacturers must keep up-to-date records of production, testing and distribution activities. This includes detailed records of all drugs manufactured, the lot number, expiration date and tests performed on each drug. These records must be kept for at least two years, and must be made available to the Board of Pharmacy upon request. By following these legal requirements, manufacturers can ensure that all pharmaceuticals they produce are safe and effective.

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