FDA Vocab
Batch Record
When it was made and what was done to follow the SOP's.
Standard Operating Procedure
step-by-step written instructions on how to do a certain task
Quality Control
A comprehensive set of activities designed to monitor and maintain systems or equipment that produce a product.
Food and Drug Administration
A federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products
Thalidomide
A mild tranquilizer that, taken early in pregnancy, can produce a variety of malformations of the limbs, eyes, ears, and heart.
Witness
A person competent to testify as to what he has seen. To attest as to observation or knowledge.
Identity
An equation that is true for every value.
Quality
Consistently producing what the customer wants while reducing errors before and after delivery.
Lot
Every vile that was made from the same batch. Notice on bottles of medicine they have batch or lot numbers.
Good Manufacturing Practices
Good manufacturing practices; mandated by the FDCA, with standards for manufacturers promulgated in regulations by the FDA
Good Laboratory Practices
Standards for the conduct and reporting of laboratory studies intended to assure the quality and integrity of safety data submitted to FDA.
Investigational New Drug Application
The United States Food and Drug Administration's Investigational New Drug program is when a pharmaceutical company obtains permission to ship an experimental drug across state lines.
Quality Assurance
The maintenance of a desired level of quality in a service or product
Strength
The potency or degree of concentration of a drug, chemical, or drink.
Verifier
a statement by an interviewer confirming the meaning of what has just been said by the person being interviewed
