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Developments in Tissue Engineered and Regenerative Medicine Products by J Ludlow, J Basu

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8

Regulatory and quality control

Abstract

Medicinal product manufacturing requires regulatory agency oversight to ensure that the products are safe for patients. Regulations require that laboratories and production facilities be constructed and maintained according to strict requirements for continued cleanliness. Employees in these facilities must be specially trained and their work monitored during the manufacturing process. The documentation required to be compliant with these regulations helps to ensure that the product is made the same way every time. If there is a problem with the performance of the product, this same documentation can be used during an investigation to find the cause and take any necessary corrective actions. This chapter ...

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