The display of written, printed or graphic matter on the Immediate container of the excipient (inactive ingredient) product. 
The process of applying the correct label to the container following completion of line-clearance.
All written, printed or graphic matter accompanying an excipient at any time while it is in-transit to the customer or being held for sale after shipment or delivery to the customer. 
Sterile solutions intended for parenteral application with a volume of 100ml or more in one container of the finished dosage form. 
A written statement by the CEP holder permitting a customer to refer to the CEP information in a Marketing Authorization application.
A written statement by the holder or designated agent or representative permitting FDA to refer to information in the DMF in support of another company's submission. 
All phases in the life of a product from the initial development through marketing until the product's discontinuation. 
An agent with a strong affinity to a metal ion. 
The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample. 
Lowest-Observed Effect Level
Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. 
A batch or a specific identified portion of a batch. (see "Batch")
See "Batch Number"
The limits within which a tool or process operates based upon minimum variability as governed by the prevailing circumctances. 
The lowest dose of substance in a study or group of studies that produces biologically significant increases in frequency or severity of any effects in the exposed humans or animals.