Glossary

An equipment change part (e.g., sleeve, filter, etc.) that is dedicated to a specific product or product range, and is identified accordingly.

Equipment tht is dedicated to a specific product or product range, and is identified accordingly.

Facility that produces a single API and its intermediates.

One or more rooms within a multi-purpose facility or dedicated area that is dedicated to a specific product or product range, and is identified accordingly.

Dietary Exposure Evaluation Model

(ANSI) Pertaining to an attribute, value, or option that is assumed when none is explicitly specified.

A standard setting or state to be taken by the program if no alternate setting or state is initiated by the system or the user. A value assigned automatically if one is not given by the user.

Discontinuities that by nature or accumulated effect (for example, total crack length) render a part or product unable to meet minimum applicable acceptable standards or specifications. This term designates rejectability.

Insufficiency or absence of one or more usable forms of enzymatic, nutritional or environmental requirements, so that development, growth or physiological functions are affected.

An exothermic reaction, such as the extremely rapid oxidation of a combustible dust or flammable vapor in air, in which the reaction progresses through the unburned material at a rate less than the velocity of sound. A deflagration can have an explosive effect.

(USP) Products of the degradation of an active ingredient that cause a loss of potency over the life of a product.

(ICH Q6A) 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.

(ICH Q5C) A molecule resulting from a change in the drug substance (bulk material) brought about over time. For the purpose of stability testing of the products described in this guideline, such changes could occur as a result of processing or storage (e.g., by deamidation, oxidation, aggregation, proteolysis). For biotechnological/biological products some degradation products may be active.

(ICH Q3B (R2)) An impurity resulting from a chemical change in the drug substance brought about during manufacture and/or storage of the new drug product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system.

(ICH Q6B) Molecular variants resulting from changes in the desired product or product-related substances 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. Such changes may occur as a result of manufacture and/or storage (e.g., deamidation, oxidation, aggregation, proteolysis). Degradation products may be either product-related substances, or product-related impurities.

(ICH Q3B (R2)) A description of the degradation products observed in the drug substance or drug product.

Deterioration of a surface finish so that pieces of the finish (or substrate) material, large enough to be visible to the unaided eye, dislodge without any direct physical contact and fall from the surface of the material.

Deterioration of a surface finish so that pieces of the finish (or substrate) material large enough to be visible to the unaided eye dislodge and fall from the surface of the material without any direct physical contact.

The removal of halogen atoms (chlorine, iodine, bromine, fluorine) from molecules, usually during biodegradation.

Di(2-ethylhexyl)phthalate

Under the HIPAA Privacy Rule, data are deidentified if either (1) an experienced expert determines that the risk that certain information could be used to identify an individual is "very small" and documents and justifies the determination, or (2) the data do not include any of the following eighteen identifiers (of the individual or his/her relatives, household members, or employers) which could be used alone or in combination with other information to identify the subject: names, geographic subdivisions smaller than a state (including zip code), all elements of dates except year (unless the subject is greater than 89 years old), telephone numbers, FAX numbers, email address, Social Security numbers, medical record numbers, health plan beneficiary numbers, account numbers, certificate/license numbers, vehicle identifiers including license plates, device identifiers and serial numbers, URLs, internet protocol addresses, biometric identifiers, full face photos and comparable images, and any unique identifying number, characteristic or code; note that even if these identifiers are removed, the Privacy Rule states that information will be considered identifiable if the covered entity knows that the identity of the person may still be determined.

Division of Emergency and Investigational Operations (ORA)

Removing dissolved ions from solution by passing the solution through a bed of ion exchange resin, consisting of polymer beads that exchange hydrogen ions for cations and hydroxyl ions for anions in solution. The ionic impurities remain bound to the resins and the hydrogen and hydroxyl ions combine with each other to form water.