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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 ...
Out of Expectation (OOE)
OOE refers to a result that is unexpected or deviates from typical patterns based on process, method, or equipment performance ...
Out of Specification (OOS)
OOS refers to a test result that falls outside the established acceptance criteria or specifications set by regulatory bodies or ...
Out of Trend (OOT)
OOT represents a result that, while within the specification limits, shows an unexpected trend or deviation compared to historical data ...
Biologic Drugs
Biologic drugs are derived from living organisms or contain components of living organisms. This category includes vaccines, blood components, gene ...
Biosimilar Drugs
Biosimilars are highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, purity, ...
Pharmacogenomics
Pharmacogenomics is an advance field of pharmacy practice, which help to develop personalized medicine for a patient. Pharmacogenomics combines the ...
Regulatory Authorities
Regulatory authorities enforce legal frameworks for new drug products or medical devices approval in market. For example, US FDA oversees ...