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A collection of essential terms and definitions related to pharmaceutical logistics, quality systems, and regulatory standards.
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GDP
Good Distribution Practice; the rulebook for shipping and storing medicine safely to ensure products are transported correctly and tracked from pickup to delivery.
cGMP
Current Good Manufacturing Practice; the rulebook for making medicine safely and correctly, requiring logistics personnel to follow SOPs and document everything accurately.
GCP
Good Clinical Practice; the rulebook for clinical trials and patient safety, ensuring clinical trial materials arrive at the correct location on time.
Cold chain
The full process of keeping a pharmaceutical product cold from pickup to delivery.
Temperature monitor/logger
A device that records the temperature during shipment to prove the product stayed safe.
Temperature excursion
A situation where a product goes outside the allowed temperature range, such as exceeding the common requirement of 2∘C to 8∘C.
Deviation
An instance when something does not happen the way it was supposed to happen according to the plan or procedure.
CAPA
Corrective and Preventive Action; the process of fixing a problem and implementing changes to prevent it from happening again.
Corrective Action
The specific part of CAPA that addresses what is done to fix a problem immediately.
Preventive Action
The specific part of CAPA that addresses what changes are made so a problem does not recur.
Veeva
A quality system software used to manage controlled quality records, including deviations, CAPAs, SOPs, and training records.
SOP
Standard Operating Procedure; a set of written instructions that must be followed and documented to maintain product quality and compliance.