Healthcare Lexicon Terminology Quiz July 2020
Healthcare Lexicon Terminology Quiz
Test your knowledge of crucial terms in the healthcare industry with our comprehensive quiz! This quiz challenges your understanding of vital concepts ranging from biologics to quality audits.
Prepare to enhance your expertise with questions that cover:
- Biopharmaceuticals
- Quality Control Systems
- Genetic Studies
- Regulatory Compliance
What is a biologic?
A biopharmaceutical which is designed to copy an existing biologic drug like Humira, Embrel or Remicade. A generic form of the innovator.
The drug from which generics or biosimilars are made – the first product of its type.
Cells derived from a single origin. The class of ‘monoclonal antibodies’ is a major source of new drugs which are biologically derived, particularly for cancer.
Products, tissues or drugs made from either human, animal or microorganism (viral, bacterial, etc.) origins include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
What is a quality audit?
The process of detecting errors in any manufacturing or operational system. In the case of diagnostic testing it refers to the accuracy and reliability of the diagnostic result generated.
The term given to the systems established within a manufacturing process or operational system to ensure and maintain the quality and consistency of the final product.
A systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
A series of processes that are linked together and controlled centrally to increase assurance of product or manufacturing process quality.
What is validation?
Any requirement with which a product, process, service, or other activity must conform.
Documented evidence that shows that an assay or process, when operated within specified ranges of critical parameters, has a high probability of meeting specifications.
A component of a kit used to carry out a chemical reaction to determine levels of different analytes.
The period of time during which a drug can be stored without decreasing in quality, safety, or efficacy.
What is CAPA?
The manner in which biopharmaceuticals and other drugs and medical devices are produced.
A quality system requirement designed to prevent recurrence product and other quality problems.
A company contracted to manufacture drug products for pharmaceutical or medical device companies.
Any board, committee or other groups formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects.
Lypholized refers to a material that has been freeze-dried.
True
False
Genetics is the study of genes and their functions.
True
False
GDP is sponsored by the European Union to ensure protection of privacy and protection of personal data.
True
False
Consent decree is the ultimate legal action which may be taken by FDA on pharmaceutical and medical device companies who have not heeded warning letters.
True
False
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