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The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others ...
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
Laser-Assisted in Situ Keratomileusis (LASIK), commonly referred to as laser eye surgery or laser vision correction, is a type of refractive surgery for the correction of myopia, hyperopia, and an actual cure for astigmatism, since it is in the cornea.
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
Website. fda .gov. The United States Food and Drug Administration ( FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and ...
A correction fluid is an opaque, usually white fluid applied to paper to mask errors in text. Once dried, it can be handwritten or typed upon. It is typically packaged in small bottles, with lids attached to brushes (or triangular pieces of foam) that dip into the fluid. The brush applies the fluid to the paper.
Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs.
Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall.
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C ), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.