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Drug Master File (DMF)
A DMF is a confidential document submitted to the FDA by a pharmaceutical manufacturer, containing detailed information about the facilities, ...
Quality Management System (QMS)
Quality Management System (QMS) is a formalized framework that outlines the structure, responsibilities, and processes for achieving quality objectives in ...
Difference Between Dissolution and Disintegration
While both terms are fundamental to pharmaceutical development, they describe distinct processes that play critical roles in tablet performance and ...
Standard Operating Procedure (SOP)
A Standard Operating Procedure (SOP) is a detailed, written instruction that outlines the steps to be taken in a specific ...
Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria ...
Basic Difference Between Biosimilar and Bioequivalence
A “Biosimilar” refers to a biologic drug that is highly similar to an already approved biologic (“reference product”), meaning it ...
Acceptable Quality Level (AQL)
International Standard and Statistical measurement used to determine the quality of the product by determining the Maximum acceptable number of ...
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 ...