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Qualification in Pharma
In simple terms, qualification ensures that equipment, systems, and facilities are installed and operate as intended. It’s all about proving ...
Fishbone Diagram in Pharmaceutical Industry
A fishbone diagram is one of the most widely used tools in quality management and is considered one of the ...
Change Control Handling
Change control is a process used in the pharmaceutical industry to manage and document changes to products, processes, or systems. ...
Quality Plan
A Quality Plan is a roadmap that defines how to ensure the quality of a product, service, or project. It ...
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 ...