ICH Terms
Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria ...
Continuous Process Verification
An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. (Ref.: ICH Q8) Key ...
CMO and CRO
Contract Manufacturer Organization (CMO) A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer. Contract Research Organization ...
Contaminants and Contamination
Contaminants Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process ...
Biodistribution (BD)
BD is the in vivo distribution, persistence, and clearance of a gene therapy (GT) product at the site of administration ...
Bioburden
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, Active Pharmaceutical Ingredient ...
Biological Activity, Drugs and Matrix
Biological Activity The specific ability or capacity of the product to achieve a defined biological effect. Potency is the quantitative ...
Business Case
The reason for making an investment (in whatever form), performing a process or using a tool. It often includes economic ...
Batch and Batch Number
Batch A defined quantity of starting material, packaging material or finished pharmaceutical product processed in a single process or series ...
Bracketing
The design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package ...