Glossary

Division of Nutrition Programs and Labeling (CFSAN)

Division of Nonprescription Regulation Development (CDER)

Division of Neurotoxicology (NCTR)

District Office (FDA)

Dead on Arrival

Drugs of Abuse

Department of Commerce (United States)

Controls records/forms that must be maintained with the production unit, including Work Instructions, recipes, drawings, standard operation procedures, part programs, production records, engineering changes notices, shift-to-shift communication, as well as the ability to edit “as planned” and “as built” information. It sends instructions down to the operations, including providing data to operators or recipes to device controls. It may also include the control and integrity of environmental, health, and safety regulations, and ISO information, such as Corrective Action procedures. Storage of historical data is provided.

(ICH Q4B) The working documents received from the PDG or one or more pharmacopeial sources (USP, Ph. Eur., or JP) that contain the proposed pharmacopeial text and any other support documents provided for Q4B evaluation.

Any written or pictorial information describing, defining, specifying, and/or reporting of certifying activities, requirements, procedures or results.

(ANSI) The aids provided for the understanding of the structure and intended uses of an information system or its components, such as flowcharts, textual material, and user manuals.

All records, in any form (including, but not limited to, written electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a trial, and the actions taken. Also referred to as “Source Documents".

System by which project documentation is issued, administered, distributed and stored.

(NIST) A management document describing the approach to a documentation effort. The plan typically describes what documentation types are to be prepared, what their contents are to be, when this is to be done and by whom, how it is to be done, and what are the available resources and external factors affecting the results.

(NIST) A description of required documentation indicating its scope, content, format, and quality. Selection of the level may be based on project cost, intended usage, extent of effort, or other factors; e.g., level of concern.

(NIST) Technical data or information, including computer listings and printouts, in human readable form, that describe or specify the design or details, explain the capabilities, or provide operating instructions for using the software to obtain desired results from a software system.

The parameter value (or evidence that the value is within control limits) is recorded at some predefined frequency for future reference.

Department of Defense (United States)

Division of Oncologic Drug Products (CDER)

Design of Experiment

Department of Energy (United States)

A methodology for designing experiments to test the effect of multiple process parameters on a given process’s outcome. The methodology allows multiple factors to be tested during an experimental run. There are several techniques, including Taguchi, fractional factorial, and Plackett-Burman.

Division of Enforcement A (CDRH)

Division of Enforcement B (CDRH)

Department of Education (United States)