Distributor(s) with which the manufacturer has a business relationship; usually a formal distribution agreement.
An analytical technique found in a compendia or other listing of official analytical methods. 
International occupational health and safety management system specification.
Out of Trend
A graphical technique for showing the performance of an accept/reject plan. 
Documented verification that the system or subsystem performs as intended over all anticipated operating ranges. 
Suggested topics that should be considered for inclusion in an EIP document. 
A route of administration where the drug product is taken by mouth (per os). 
Specific practices addressing livestock breeding, cultivation of crops, the level of processing and the production of food. 
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]
Sample collected directly from the material. 
Materials present in an excipient that arise as a consequence of the raw materials and/or manufacturing process and are not concomitant component. 
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.
Activities conducted by a contract acceptor under a written agreement with a contract giver. (ICH Q10) 
Organic Volatile Impurities, USP/NF General Chapter <467>