A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Facilities

Facilities are commonly defined in GMP environment as room, suite or plant used for the Manufacture of Products.

FDA Form 481

The FDA Form 481 is the official FDA Form which must filled out by an FDA Investigator to officially request the collecting of a sample at a site.

FDA Form 482

The FDA Form 482 is the official FDA notice of Inspection. This document gives the FDA the authority to enter and inspect per Section 704 of the FD&C Act. 

FDA Form 483

The FDA Form 483 is the official FDA inspectional observation sheet. This document is issued at the end of the inspection by the FDA and lists all significant objectionable findings noted during an inspection.

FDA Investigator

FDA Investigator is the Inspector / Auditor from the FDA conducting inspections to enforce the Food, Drug and Cosmetic Act.

Fiber

Any particulate contaminant with a length at least three times greater than its width. 

Field Alert

The Flied Alert is a notification to the US FDA of a potential or actual problem with a marketed drug product or device, e.g. OOS within the shelf life during ongoing stability studies a for marketed drug product.

Final Intermediate

The final Intermediate is defined as the final synthesis starting material for the process step, which produces the Drug Substance / Active Pharmaceutical Ingredient (API).

Finished Device

Device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Finished Product

Finished Product is defined as a final product that went trough all stages of manufacturing, including packaging, and is in its final, labelled primary and secondary packaging. These may be Drug Substances / Active Pharmaceutical Ingredients (API) APIs or Drug Products.

Food and Drug Administration-FDA

Food and Drug Administration. The FDA is the heath agency of the United States

Functional Specifications

Functional Specifications are commonly understood as the specifications that define functions, standards and permitted tolerances of systems or parts of systems e.g. components such as equipment. Functional Specifications will therefore define the operating capabilities of the equipment.