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.
