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Pharmaceutical Glossary Pharmaceutical Glossary
Welcome to the Körber Pharma Life Sciences Glossary—your comprehensive resource for understanding key pharmaceutical and biopharmaceutical terms. Here, we’ve curated definitions, insights, and connections to help you explore complex concepts with clarity and precision. From foundational terms to advanced industry terminology, our glossary is designed to support your journey through the evolving world of life sciences.
A
Active Pharmaceutical Ingredient (API)
An Active Pharmaceutical Ingredient (API) is the biologically active component in pharmaceutical products responsible for producing the desired therapeutic effects.
Active Pharmaceutical Ingredient (API) Definition
Aseptic isolator
An aseptic isolator is a specialized containment device designed to provide a controlled and sterile environment for handling pharmaceutical products and processes.
Automated visual inspection (AVI)
Automated Visual Inspection (AVI) is a technology-driven method used in the pharmaceutical industry to ensure product quality and safety.
B
Batch Record
A Batch Manufacturing Record (BMR), or simply batch record, is a critical document in pharmaceutical manufacturing.
Biosimilar
A biosimilar is a biologic medication created to closely resemble an already approved reference biologic in terms of structure, function, safety, efficacy, and quality.
Blister packaging
Blister packaging is a widely used method in the pharmaceutical industry, designed to protect individual doses of medication from external factors such as moisture, light, and contamination.
C
Current Good Manufacturing Practices (cGMP)
Current Good Manufacturing Practices (cGMP) refers to regulations enforced by regulatory authorities such as the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), and the European Medicines Agency (EMA) to ensure that pharmaceutical products, medical devices, and food products are consistently produced and controlled according to strict quality standards.
D
Drug Delivery System
A drug delivery system refers to the methods, technologies, or devices used to transport pharmaceutical compounds into the human body to achieve a therapeutic effect.
G
Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) are a set of regulatory guidelines, codes, and standards designed to ensure that pharmaceutical, medical device, and food products are consistently manufactured and controlled according to established quality requirements.
I
Intelligent Packaging
Intelligent packaging refers to advanced packaging solutions designed to monitor, protect, and enhance pharmaceutical products throughout their lifecycle.
L
Line Clearance
Line clearance is a critical quality control procedure used in pharmaceutical manufacturing to ensure that production and packaging lines are free of materials, equipment, or residues from a previous batch.
M
Manufacturing Execution System (MES)
A manufacturing execution system (MES) is a digital solution that helps pharmaceutical manufacturers monitor, control, and optimize production processes in real time.
S
Single-Use Systems (SUS)
Single-use systems (SUS) are pre-assembled, disposable components used in biopharmaceutical manufacturing processes.
Single-Use Systems (SUS) Definition
Standard Operating Procedure (SOP)
A Standard Operating Procedure (SOP) is a documented set of step-by-step instructions designed to ensure that specific processes are carried out consistently and efficiently in compliance with regulatory requirements.
T
Track & Trace
Track and trace in the pharmaceutical industry refers to a system designed to monitor and record the movement of pharmaceutical products throughout the supply chain.
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