E
Earliest Expiry/First Out Principle Concept (EEFO)

A distribution procedure to ensure that the stock with the earliest expiry date is distributed and/or utilized before an identical stock item with a later expiry date is distributed and/or utilized. [3, 18]

EDI

Estimated Daily Intake

EDQM

European Directorate for the Quality of Medicines. [6]

EEFO

Earliest Expiry/First Out Principle Concept

Effectiveness

An expression of the degree to which activities have produced the effects planned. [25]

Efficiency

The relationship between the results of activities and the corresponding effort expended in terms of money, resources and time. [25]

EIP

Excipient Information Package

Electronic Document

A document that is stored on a computer in an electronic file such as: Portable Document Format (PDF), scanned image (TIF, JPEG, etc.) or Microsoft application such as Word, Excel, or Access.

Enabler

A tool or process which provides the means to achieve an objective. (ICH Q10) [11]

Endotoxin

Lipopolysaccharides (LPS), also known as lipoglycans and endotoxin, are large molecules consisting of a lipid and a polysaccharide found in the outer membrane of Gram-negative bacteria, and elicit strong immune responses in animals. Lipopolysaccharides may be released on destruction of the bacteria, and that the immunogenic response leads to an increase in body temperature.

Equipment

The implements used in the manufacture of an excipient. [5]

Equivalence test

A test that determines the equivalence between the multisource product and the comparator product using in vivo and/or in vitro approaches. [24]

Estimated Daily Dose

see Estimated Daily Intake [7]

Estimated Daily Intake (EDI)

The estimated maximum daily intake (I) of the dosage form (tablets per day) and the concentration (C) of the excipient in each dosage form (mg/tablet) divided by the body weight (BW) in kilograms [7]

BW

EDI = I * C

Excipient

Substances other than the API which have been appropriately evaluated for safety and are intentionally included in a drug delivery system. [1, 3, 4, 6]

Excipient Information Package (EIP)

An IPEC initiative to provide standards for the exchange of data between excipient suppliers and excipient users. The EIP is comprised of the Site Quality Overview, Product Regulatory Datasheet, and Site and Supply Chain Security Overview. IPEC’s Standardized Excipient Information Protocol User Guide provides information on the preparation of the EIP documents. [4]

Excipient Realization

Development, manufacture, launch and sale of an excipient with the quality attributes appropriate to meet the needs of internal customers, pharmaceutical users, regulatory authorities, health care professionals, and patients.

Expected

Elements of the EIP documents that should be included and addressed in the EIP documents. [6]

Expiration Period

The duration, normally expressed in months or years from the date of manufacture, within which the excipient can continue to be used. [4]

Expiry (Expiration) Date

The date designating the time during which the excipient is expected to remain within specifications and after which it should not be used. [1, 3, 4, 6]

Extended Release

Products which are formulated to make the drug available over an extended period after administration. [12]

Extraneous Contaminant

An impurity arising from any source extraneous to the manufacturing process. [15]