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All pharmaceutical manufacturing facilities need to adhere strictly to FDA-approved regulations. The importance on the compliance of facility design with cGMP regulations as well as the various procedures associated with pharmaceutical production, so drugs are manufactured under conditions that meet FDA approval.
Failure to meet FDA regulations can result in responsive action by the authorities against the product or the responsible facility, depending upon the seriousness of non-compliance. The company may have to recall the product under orders of the FDA, to ensure it does not cause additional harm or risk to the public.
CGMP requirements can be useful in ensuring the efficacy, quality and safety of pharmaceutical products by making sure facilities are in good operating condition, with sufficiently calibrated and well-maintained equipment, trained and experienced staff and reliable and efficient processes.
While a utility system cannot affect product quality on its own, it forms an integral part of the manufacturing process using and meeting expectations of regulated manufacturers to satisfy requirements for design, installation, operation, and performance of controlled processes to assure that they can consistently produce product meeting defined quality requirements.