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Change-Being-Effected Supplement (CBE) -
A submission to an approved 
application reporting changes that FDA has identified as having moderate potential 
to adversely affect the identity, strength, quality, purity, or potency of a product as 
they may relate to the safety or effectiveness of the product. A CBE supplement 
must be received by FDA before or concurrently with distribution of the product 
made using the change. 
36.
CEP:
CEP stands for Certification of suitability of European Pharmacopoeia 
monographs. COS (―Certificate of Suitability‖) means the same and, even if often 
used, is not the official acronym. 
37.
Combination product: 
A drug product which contains more than one drug 
substance. 
38.
Contamination:
The undesired introduction of impurities of a chemical or 
microbiological nature, or of foreign matter, into or onto a raw material, 
intermediate, or API during production, sampling, packaging or repackaging, 
storage or transport. 
39.
COS:
A certificate provided to the manufacturer by the European Directorate 
for the Quality of Medicines & HealthCare to certify that the relevant monograph in 
the European Pharmacopoeia adequately controls the substance as manufactured by 
the company at the time the certificate was granted. 
40.
Degradation Product
: An impurity resulting from a chemical change in the 
drug substance brought about over time and/or by the action of e.g., light, 
temperature, pH, water, or by reaction with an excipient and/or the immediate 
container/closure system. Also called decomposition product. 
41.
Detection Limit: 
The detection limit of an individual analytical procedure is 
the lowest amount of analyte in a sample which can be detected but not necessarily 
quantitated as an exact value. 
42.
Dissolution:
The process by which drug dissolves out of a dosage form and is 
made available for absorption from the gastro-intestinal tract. In vitro measurements 

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are made in a range of apparatus types. The requirements for different types of 
dosage forms are given in each pharmacopoeia. 
43.