Pharmaceutical Quality Assurance Consulting Key Terms
Learn the key terms related to pharmaceutical quality assurance consultingPharmaceutical quality assurance consulting is a vital part of the healthcare industry, ensuring that hospitals, pharmacies, and healthcare facilities like nursing homes and rehabilitation centers operate at the highest standard of quality and patient care.
Pharmaceutical consulting is accompanied by a lot of jargon that is specific to the healthcare industry. It's important to understand key terms related to pharmaceutical quality assurance consulting to guarantee that your healthcare business is operating according to safety, sanitation and quality standards.
Ordered recallAn ordered recall is an action taken by the Food and Drug Administration (FDA) when a prescription medication is found to be unsafe due to manufacturer defect or continuing research into possible side effects and interactions. The product is taken off the market and no longer prescribed.
Market withdrawalA market withdrawal occurs when the FDA notifies every manufacturer of a specific product that there are safety concerns with unknown origins, resulting in a market-wide withdrawal of the food or drug in question.
U.S Food and Drug Administration.
Good manufacturing practicesGood manufacturing practices, or GMP, are the federal healthcare standards set for quality control in storage, acquisition, dispensing and patient care related to medications, healthcare and medical devices.
Active pharmaceutical ingredientsActive pharmaceutical ingredients are the chemical components of a medication that have an affect on the body. Other chemical components, often referred to as binders, work to hold the active ingredients together cohesively but do not have an active impact on the body's systems.
Clinical trial monitoringClinical trial monitoring is a quality control system used to ensure quality and accuracy of the trials conducted to determine effectiveness of medications or medical devices. Clinical trial monitoring ensures that standards of quality are followed during testing and that results and data are reported accurately and indiscriminately.
National Institute of Allergy and Infectious Diseases explains the purpose of clinical trial monitoring and how monitoring is conducted. Read more about the standards for safety and monitoring and the different regulations for human test subjects.
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