(1999; 168 pages) [Spanish]
The definitions given below apply to the terms used in these guidelines. They may have different meanings in other contexts.
The blending of carry-over material from one grade of an excipient with another, usually due to a continuous process.
drug master file1
Detailed information concerning a specific facility, process or product submitted to the drug regulatory authority, intended for incorporation into the application for marketing authorization.
1 This term appears to be specific to United States regulations.
A product which simulates a group of similar products.
A concentrated solution from which the product is obtained by evaporation, freezing, and/or crystallization.
Substances, other than the active ingredient, which have been appropriately evaluated for safety and are included in a drug delivery system to:
- aid in the processing of the drug delivery system during its manufacture;
- protect, support or enhance stability, bioavailability, or patient acceptability:
- assist in product identification; or
- enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.