Operating Characteristic

Official Distributor(s)

Distributor(s) with which the manufacturer has a business relationship; usually a formal distribution agreement.

Official Method (Official Source)

An analytical technique found in a compendia or other listing of official analytical methods. [7]

OHSAS 18001

International occupational health and safety management system specification.


Out of Trend

Operating Characteristic (OC) Curve

A graphical technique for showing the performance of an accept/reject plan. [4]

Operational Qualification (OQ)

Documented verification that the system or subsystem performs as intended over all anticipated operating ranges. [23]


Suggested topics that should be considered for inclusion in an EIP document. [6]


Operational Qualification

Oral (p.o)

A route of administration where the drug product is taken by mouth (per os). [7]

Organic (organically grown)

Specific practices addressing livestock breeding, cultivation of crops, the level of processing and the production of food. [6]

Original Manufacturer

Person or company manufacturing a material to the stage at which it is designated as a pharmaceutical starting material. (GDP Guide/WHO Good Trade and Distribution Practices) [3, 4, 18]

Original sample

Sample collected directly from the material. [26]

Other Components

Materials present in an excipient that arise as a consequence of the raw materials and/or manufacturing process and are not concomitant component. [4]

Out of Trend (OOT)

A result that is not expected based on an examination of previous data when presented in chronological order, but remains within specification. A result showing a distinct offset from the rest of the data set.

Outsourced Activities

Activities conducted by a contract acceptor under a written agreement with a contract giver. (ICH Q10) [11]


Organic Volatile Impurities, USP/NF General Chapter <467> [6]