Date of Manufacture

A date indicating the completion of the final manufacturing process (as defined by the supplier for the particular excipient and process). [4, 8]

Date Retested

The date when retesting is performed by an excipient supplier to extend the length of time that the material may be used. [8]

Decision Maker(s)

Person(s) with the competence and authority to make appropriate and timely quality risk management decision. [10]

Decision Tree

A visual presentation of the sequence of events that can occur, including decision points. [5]


Materials resulting from the decomposition of the excipient. [7]

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. [12]

Delayed Release

Release of a drug (or drugs) at a time other than immediately following oral administration. [12]

Design of Experiments

A series of planned experiments that uses statistical principles to select variable parameters with the objective of optimizing process performance. [4]

Design Qualification (DQ)

Documented evidence that the facilities and supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of appropriate GMPs and indended use. [23]

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. [4, 11]


The ability to discover or determine the existence, presence, or fact of a hazard. [10]

Detection Limit

The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value. [14]

Developmental Toxicity

Any adverse effect induced prior to attainment of adult life. It includes effects induced or manifested in the embryonic or fetal period and those induced or manifested postnatally. [7]


Departure from an approved instruction or established standard. [1, 2, 3]


The division and movement of pharmaceutical products from the premises of the manufacturer of such products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments. [17]


All parties in the distribution/supply chain starting from the point at which an excipient is transferred outside the control of the original manufacturer’s material management system including parties involved in trade and distribution, (re)processors, (re)packagers, transport and warehousing companies, forwarding agents, brokers, traders, and suppliers other than the original manufacturer. (from Into/Scope of GDP)


Those parties involved in trade and distribution, (re)processors, (re) packagers, transport and warehousing companies, forwarding agents, brokers, traders, and suppliers other than the original manufacturer.

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.). NOTE: currently regulatory authorities throughout Europe do not have a system to accept EXCIPIENT master files.

Document Control

The set of procedures to ensure documents can be identified as to their status e.g. draft, revised, approved, obsolete, superseded, etc [4]

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.

Documented Procedure

A written procedure meeting the requirements of 4.2.3 (document control section of quality standard such as ISO 9001 - section defines requirements for document control to assue that quality related documents affecting work activities show evidence of reivew and approval by authorized personnel prior to issuing new or revised documentation).

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. [13]


Design Qualification


Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient. In this document, the terms drug, medicine and pharmaceutical product (see below) are used interchangeably. [25]

Drug Master File (DMF)

Detailed information concerning a specific facility, process, or product submitted to a Drug Regulatory Authority (such as the United States Food and Drug Administration, Health Canada, and the Japanese Pharmaceutical and Medical Devices Agency) intended for incorporation by reference into a new drug application, supplemental new drug application, abbreviated new drug application, investigational new drug application, or biological license application. [7]

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. [7]

Drug Regulatory Authority

A national body that administers the full spectrum of drug regulatory activities, including at least all of the following functions in conformity with national drug legislation:
* marketing authorization of new products and variations of existing products (including DMF);
* quality control laboratory testing;
* monitoring of adverse drug reactions;
* provision of drug information and promotion of rational drug use;
* good manufacturing practice (GMP) inspections and licensing of manufacturers, wholesalers and distribution channels;
* enforcement operations; monitoring of drug utilization. [25]

Drug Substance

see Active Pharmaceutical Ingredient.