Glossary of Terms - O

Object Database Management System (ODBMS)
A database management system specifically designed to manage and store complex objects and their complex relationships; that is, such items are stored as objects rather than as tables or fields. They support modeling and creation of data as objects, allowing for greater flexibility in tracking parent method sets and subcomponents. Such systems may be better than relational database management systems at meeting the data integrity requirements of CFR 21 Part 11.

Occupancy
The purpose for which a building or part thereof is used or intended to be used.

Occupancy Classification


ODBMS


Ohm
Unit of electrical resistance in a circuit, such that a potential difference of one volt across a load of one ohm produces a current of one ampere.

Oncogene
A gene that when expressed as a protein can lead cells to become cancerous, usually by removing the normal constraints on growth.

Open
Exposed to the environment, not closed.

Open System
A system that fails to meet one or more of the requirements that set the criteria for a closed system.

Operating Parameter
Any information entered into an automated system that is used for automated equipment operation. Or, a parameter indicative of the operating condition of a system.

Operating Range
The validated acceptance criteria within which a control parameter must remain, wherein acceptable product is being manufactured.

Operating System (OS)
The most important program run on a computer because it manages all the other programs. Operating systems perform basic tasks, such as recognizing input from the keyboard, sending output to the display screen, keeping track of files and directories on the disk, and controlling peripheral devices such as disk drives and printers. For large systems, the OS has even greater responsibilities and powers. It regulates traffic, making sure that different programs and users running at the same time do not interfere with each other. The operating system also is responsible for security, ensuring that unauthorized users do not access a system. Microsoft Windows NT, LINUX, and UNIX are operating systems.

Operating Variables
All factors of operation, including control parameters that may potentially affect process state of control and/or fitness for use of the product.

Operation
Room condition when normal process operations are undertaken.

"Operational" Cleanroom
ISO 14644-1 defines "operational" occupancy state as "condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon". (

Ophthalmic
Of, or relating to the eye, ocular.

Ophthalmics
Pertaining to products for the eyes. GMP requirements for the preparation of ophthalmics are essentially identical to those for parenterals.

OQ (Operational Qualification)
Documented verification that aspects of a facility system that can affect product quality perform as intended throughout anticipated operating ranges.

Oral
Relating to the mouth.

Oral Product
A pharmaceutical product meant to be introduced through the mouth in the form of a tablet, capsule, or suspension.

Oral Solid Dosage Drug
Formulated in a solid or powder form for patient to ingest orally.

Orbital Welding
Automatic or machine welding of tubes or pipe in-place with the electrode rotating (or orbiting) around the work. Orbital welding can be done with the addition of filler material or as a fusion process without the addition of filler.

Organelles
Membrane-surrounded structures found in eukaryotic cells; they contain enzymes and other components required for specialized cell function.

Organic
Organic matter is a broad category that includes both natural and man-made molecules containing carbon and hydrogen. All living matter in water is made up of organic molecules. The most common are by-products of vegetative decay such as tannins, lignins, and humic acid.

Organic Peroxide
An organic compound that contains the bivalent -0-0- structure and which may be considered to be a structural derivative of hydrogen peroxide where on or both of the hydrogen atoms have been replaced by an organic radical. Organic peroxides can present an explosion hazard (detonation or deflagration) or they can be shock sensitive. They can also decompose into various unstable compounds over an extended period.

Organism
A single, autonomous living thing. Bacteria and yeasts are organisms; mammalian and insect cells used in culture are not.

Origin
Point or region where DNA replication is begun. Often abbreviated Ori.

Orphan Drug
The FDA grants Orphan Drug status to one company for a drug that is believed to substantially increase the life expectancy of the treated patient for a particular disease. This excludes other companies from receiving an FDA license to produce a similar drug for a finite period (usually 7 years), thereby allowing the company producing the drug to recuperate their R&D expenses.

OS


Osmosis
The diffusion of a solvent through a semipermeable membrane from a solution of higher concentration to one of lower concentration until there are equal concentrations of fluid on both sides of the membrane.

Osmotic Pressure
Pressure generated by the osmotic flow of water through a membrane into a (aqueous) phase containing a solute in a higher concentration.

Out of Specification
An examination, measurement, or test result that does not comply with preestablished criteria.

Overlapping Clones


Oxidation (on metals)
The formation of an oxide layer on a metal surface. When oxidation occurs because of welding, it is visible as discoloration. The discoloration or heat tint produced by oxidation has been associated with the onset of corrosion in stainless steel piping systems.

Oxide Thickness
The depth at which the oxide signal has fallen to half the maximum peak height. Typical values for well electropolished 316L stainless steel range from 20 to 50 angstroms (Å).

Oxide Layer
In welding, an area usually located in the heat-affected zone (HAZ) of the weldment where an oxidation reaction has taken place.

Oxidizer
A material other than a blasting agent or explosive, that readily yields oxygen or other oxidizing gas, or that readily reacts to promote or initiate combustion of combustible materials. Oxidizers are subdivided as follows:

1. Class 4 - An oxidizer that can undergo an explosive reaction due to contamination or exposure to thermal or physical shock. In addition, the oxidizer will enhance the burning rate and may cause spontaneous ignition of combustible materials.

2. Class 3 - An oxidizer that will cause a severe increase in the burning rate of combustible materials with which it comes in contact or that will undergo vigorous, self-sustained decomposition due to contamination or exposure to heat.

3. Class 2 - An oxidizer that will cause a moderate increase in the burning rate or that may cause spontaneous ignition of combustible materials with which it comes in contact.

4. Class 1 - An oxidizer whose primary hazard is that it slightly increases the burning rate but does not cause spontaneous ignition when it comes in contact with combustible materials.

Ozone
Formed by an electric discharge or by the slow combustion of phosphorus, ozone is a modified and condensed form of oxygen, in which three atoms of oxygen are combined to form the molecule, O3. Because it is a powerful oxidizing agent it is used in deionized water systems to kill bacteria and to reduce by oxidation the amount of Total Organic Carbon (TOC) in the water. Air containing a perceptible amount of ozone has an odor suggesting chlorine or sulfurous acid gas.