Small pharmaceutical manufacturing company

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Reference no: EM133825664

Question

You work as a legal assistant to the attorney who serves as in-house counsel for a small pharmaceutical manufacturing company. Your company currently contracts with a corporation in Taiwan to manufacture its sole product-an injectable (aka finished pharmaceutical). Your company, however, has two additional drugs in the late stages of clinical trials and is planning on manufacturing those drugs in a plant it is constructing in Oro Valley. The company's executives, including the manufacturing director, have asked your boss to research the FDA regulations governing the good manufacturing processes for finished pharmaceutical manufacturing facilities. The executives would like to know the specific regulations that would apply to their proposed new facility, including what specific types of personnel they will need to hire, how such personnel should be organized, how the building and facilities should be operated and controlled, and to what degree should the manufacturing equipment be tested to ensure proper operation. Please provide any/all regulations you believe apply and summarize the key points you believe will apply to the new manufacturing facility.

Reference no: EM133825664

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