D
Date of Manufacture

A date indicating the completion of the final manufacturing process (as defined by the supplier for the particular excipient and process).

Date Retested (retest date)

See retest date [1] [8] [13] [15] [16]

Decision Tree

A visual presentation of the sequence of events that can occur, including decision points.

Degradation product

A molecule resulting from a chemical change in the drug molecule brought about over time and/or by the action of e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Also called decomposition product. [7]

Design of Experiments (DoE)

A structured, organized method for determining the relationship between factors affecting a process and the output of that process. Also known as “formal experimental design” [9]

Design Space

The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. [9] [11]

Distribution

The division and movement of excipients from the premises of the manufacturer via distributor(s) to the excipient user. [1] [2]

Distributor

A company procuring, importing, holding, supplying or exporting excipients. A distributor takes possession and ownership of the excipient(s), including e.g. repackaging, warehousing and transportation, but does not alter the excipients’ physical and/or chemical characteristics e.g. processing / reprocessing. [1] [2]

DMF

Drug Master File

DMF Holder

The company or individual who has filed a Drug Master File with a Drug Regulatory Authority (e.g. US FDA, EU EMA, etc.). [29]

Document Management System

The system that controls the life cycle of documents; their creation, reviewed, publication, and use, as well as how they are disposed of or retained.

DoE

Design of Experiments

Dosage Form

A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients. [3] [20]

DQ

Design Qualification

Drug Product

A finished dosage form, for example, tablet, capsule, or solution, that contains an active ingredient, generally with excipients, that has been prepared for consumer use and that has undergone all stages of production including packaging and labeling. In Europe aka "medicinal product." [1] [2]