Pharmaceutical Quality Assurance Consulting Key Terms

Learn the key terms related to pharmaceutical quality assurance consulting

Pharmaceutical 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.

 

Accreditation

Accreditation is an evaluation process conducted by a certified accreditor that inspects hospitals, pharmacies and other healthcare facilities. The accreditor gives approval once assured that the facility is complying with all state and federal regulations and delivering the highest quality of patient care and support.
Try: ISQua explains what health care accreditation entails and the process by which healthcare facilities are evaluated.

Ordered recall

An 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.
Try: Dialog explains the three classes of an ordered recall and the steps taken by the FDA to issue an ordered recall.

Market withdrawal

A 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.
Try: Read more about the market withdrawal policies set by the U.S Food and Drug Administration.

Good manufacturing practices

Good 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.
Try: The GMP Institute offers more information on GMP regulations.

Active pharmaceutical ingredients

Active 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.
Try: DrugDevelopment-Technology.com defines active pharmaceutical ingredients and provides resources to learn more about their applications.

Clinical trial monitoring

Clinical 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.
Try: The 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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