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Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.
Medpace Holdings, Inc. is a global clinical research organization (CRO) based in Cincinnati, Ohio, [2] [1] [3] employing approximately 5,400 people. Medpace's mission statement is "to accelerate the global development of safe and effective medical therapeutics" through its high science and disciplined operating approach that leverages local, regulatory, and deep therapeutic expertise across ...
Cardinal Health, Inc. is an American multinational health care services company, and the 14th highest revenue generating company in the United States. Headquartered in Dublin, Ohio, the company specializes in the distribution of pharmaceuticals and medical products, serving more than 100,000 locations.
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