European Commission
Estimated Daily Intake
European Directorate for the Quality of Medicines
Earliest Expiry/First Out Principle Concept
European Federation of Pharmaceutical Industries and Associations
Excipient Information Package
Trace metals, catalysts and environmental contaminants which may occur naturally, added intentionally or introduced inadvertently. [EIP]
European Medicines Agency (Europe)
Lipopolysaccharides (LPS), also known as lipoglycans and endotoxin, are large molecules consisting of a lipid and a polysaccharide found in the outer membrane of Gram-negative bacteria, and elicit strong immune responses in animals. Lipopolysaccharides may be released on destruction of the bacteria, and that the immunogenic response leads to an increase in body temperature. [EIP]
The implements used in the manufacture of an excipient. [EIP]
Substances other than the API which have been appropriately evaluated for safety and are intentionally included in a drug delivery system. [1] [3] [15] [16]
An IPEC initiative to provide standards for the exchange of data between excipient suppliers and excipient users. The EIP is comprised of the Site Quality Overview, Product Regulatory Datasheet, and Site and Supply Chain Security Overview. IPEC’s Standardized Excipient Information Protocol User Guide provides information on the preparation of the EIP documents. [EIP] [36]
A toxin released by a living bacterial cell into its surroundings. [EIP]
The date designating the time during which the excipient is expected to remain within specifications and after which it should not be used. [1] [8] [15] [16]
