A Model for Pharmaceutical Supply Chain Quality Agreements
7 Mar 2014Regulatory agencies around the globe have defined A Quality Agreement (QA) as a written document outlining the roles and responsibilities for the owner of the drug and the Contract Manufacturing Organization (CMO) in terms of basic cGMP regulations. This white paper presents a model for pharmaceutical supply chain Quality Agreements and discusses their importance.
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RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices.

