Pharma Logistics Flashcards

Vocabulary flashcards covering essential pharmaceutical logistics concepts including regulatory practices, temperature monitoring, and quality management systems.

GDP

Good Distribution Practice; the rulebook for shipping and storing medicine safely.

cGMP

Current Good Manufacturing Practice; the rulebook for making medicine safely and correctly.

GCP

Good Clinical Practice; the rulebook for clinical trials and patient safety.

Cold chain

The full process of keeping a product cold from pickup to delivery.

Temperature monitor/logger

A device that records the temperature during shipment.

Temperature excursion

When the product goes outside the allowed temperature range, such as exceeding the $2\,^{\circ}C$ to $8\,^{\circ}C$ range.

Deviation

When something does not happen the way it was supposed to happen, such as a late delivery, missing document, or temperature going out of range.

CAPA

Corrective and Preventive Action; the process of fixing a problem and preventing it from happening again.

Corrective Action

The part of CAPA that focuses on what is done to fix a problem immediately.

Preventive Action

The part of CAPA that focuses on what to change so a problem does not happen again.

Veeva

A quality system software used to manage controlled quality records such as deviations, CAPAs, SOPs, and training records.

SOP

Standard Operating Procedure; documented instructions that must be followed accurately to maintain product quality.