Glossary

Hierarchy of Input-Processing-Output

High efficiency particulate air filter, a filter with DOP efficiency in excess of 99.97% on 0.3 micron particles.

A filter with an efficiency in excess of 99.97% for 0.3 µm particles.

A filter with an efficiency in excess of 99.97% for 0.3 micron particles.

Systems or functions that typically have a direct impact on data integrity, product quality or patient safety.

Liquid chromatography performed at high pressures (as high as 8,000 psi) with small-particle packings (as small as 3μm in diameter). HPLC methods include reverse-phase, normal-phase, size-exclusion, ion-exchange, ion, chiral, hydrophobic-interaction, and hydrophilic-interaction chromatography. HPLC has been used since the late 1960s, whereas liquid chromatography has been in use since 1903.

Sometimes called high-performance liquid chromatography, is a separation technique based on a solid stationary phase and a liquid mobile phase. Separations (into distinct bands) are achieved by partition, adsorption, or ion-exchange processes, depending upon the type of stationary phase used. Each band is then profiled as the solvent flows through a UV detector, or by fluorescence, or refractive index detectors.

The equipment that includes the stainless steel vessels, tube, pipe, fittings, and valves used to manufacture and transport drug products.

Water conforming to USP Monographs or equivalent.

Disinfectant capable of destroying all microorganisms with the exception of high numbers of resistant spores.

A programming language which requires little knowledge of the target computer, can be translated into several different machine languages, allows symbolic naming of operations and addresses, provides features designed to facilitate expression of data structures and program logic, and usually results in several machine instructions for each program statement. Examples are PL/1, COBOL, BASIC, FORTRAN, Ada, Pascal, and "C".

A boiler furnishing steam at a pressure in excess of 15 pounds per square inch (psi) (103 kPa), or hot water at a temperature in excess of 250°F (121°C) or at a pressure in excess of 160 psi (1,103 kPa).

Robotic methods used to sort through thousands of chemical compounds by running assays on many at a time.

A metal containing various alloying constituents formulated to provide enhanced corrosion resistance and possibly improved mechanical properties beyond those that are typically observed in UNS S31603 (Type 316L) stainless steel.

A DNA sequence that is very similar in several different kinds of organisms. Scientists regard these cross species similarities as evidence that a specific gene performs some basic function essential to many forms of life and that evolution has therefore conserved its structure by permitting few mutations to accumulate in it.

Genotoxic compounds that are known to be, or highly likely to be, carcinogenic to humans, compounds that can produce reproductive and/or developmental effects at low dosages, and compounds thar can produce serious target organ toxicity or other significant adverse effects at low dosages.

Water intended for use in the preparation of products where water of high biological quality is needed, except where Water for Injection is required. Highly Purified water is obtained from water that complies with the regulations on water intended for human consumption laid down by the competent authority. Current production methods include, for example, double-pass reverse osmosis coupled with other suitable techniques such as ultrafiltration and deionization. Highly Purified water meets the same quality standards as WFI but the production methods are considered less reliable than distillation and thus it is considered unacceptable for use as WFI.

(EMEA) Water intended for use in the preparation of products where water of high biological quality is needed, except where Water for Injection is required. Highly Purified water is obtained from water that complies with the regulations on water intended for human consumption laid down by the competent authority. Current production methods include, for example, double-pass reverse osmosis coupled with other suitable techniques such as ultrafiltration and deionization. Highly Purified water meets the same quality standards as WFI but the production methods are considered less reliable than distillation and thus it is considered unacceptable for use as WFI.

(ICH Q6A) 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).

Health Industries Manufacturers Association

Health Insurance Portability and Accountability Act

A federal law that was designed to allow portability of health insurance between jobs. In addition, it required the creation of a federal law to protect personally identifiable health information; if that did not occur by a specific date (which it did not), HIPAA directed the Department of Health and Human Services (DHHS) to issue federal regulations with the same purpose. DHHS has issued HIPAA privacy regulations as well as other regulations under HIPAA.

Hierarchy of Input-Processing-Output

High Impact Polystyrene