Hazard Analysis Critical Control Point [6]


The term indicates that an item is permitted and fit for consumption by Muslims. [6]


Damage to health, including the damage that can occur from loss of product quality or availability. [10]


The potential source of harm (ISO/IEC Guide 51). [10]

Health Establishment

A health establishment is the whole or part of a public or private facility, building or place, whether operated for profit or not, that is operated or de-signed to provide health care services including the supply of pharmaceutical products to the end user. [17]

Herbal Products

Medicinal products containing, exclusively, plant material and/or vegetable drug preparations as active ingredients. In some traditions, materials of inorganic or animal origin can also be present. [15]

Highly Water Soluble Drugs

Drugs with a dose/solubility volume of less than or equal to 250 mL over a pH range of 1.2 to 6.8. (Example: Compound A has as its lowest solubility at 37± 0.5°C, 1.0 mg/mL at pH 6.8, and is available in 100 mg, 200 mg, and 400 mg strengths. This drug would be considered a low solubility drug as its dose/solubility volume is greater than 250 mL (400 mg/1.0 mg/mL = 400 mL). [12]

Historical Norms

The totality of the data set for the excipient and expected range values that have been obtained over time. This includes but is not limited to comparison of chemical & physical properties, microbiological properties, composition profile, stability and/o

HM 232

US Department of Transportation (DOT) Regulation, 49 CFR Part 172, Hazardous Materials: Security Requirements for Offerors and Transporters of Hazardous Materials. [6]


A material is regarded as homogeneous when it is all of the same origin (e.g. from the same batch) and as nonhomogeneous when it is of differing origins. [26]

Homogeneous Material

Material of uniform consistency and composition throughout a batch. [1] [3, 18]


A violent reaction by the immune system to a substance that is normally considered harmless. [6]