CORRECT Answers
Quality Control - CORRECT ANSWER - Activities that evaluate, monitor, or regulate
services rendered to the consumer If nursing is to strive for excellence, criteria should be pushed
to optimal levels rather than minimally acceptable levels
What is the process of quality control? - CORRECT ANSWER - -Criterion or standard is
determined
-Information is collected to determine if the standard has been met
-Educational or corrective action is taken if the criterion has not been met
Standards Development - CORRECT ANSWER - Development of a predetermined level
of excellence that serves as a guide for practice. Established by an authority and Communicated
to and accepted by the people affected by them
CGMP - CORRECT ANSWER - current good manufacturing practice
Standards for CGMP - CORRECT ANSWER - -Established by the FDA
-Ensure that minimum standards are met for drug product quality- Promulgated in 1963 under
Kefauver-Harris Drug Amendments
-Code of Federal Regulations
Good Manufacturing Practice (GMP) is defined as - CORRECT ANSWER - "The part of
Quality Assurance which ensures that products are consistently produced and controlled in
accordance with the quality standards appropriate to their intended use"
"Food & Drug Administration's regulations that describe the methods, equipment and facilities
and controls required for producing human and veterinary products"