Blog

Shipping Validation and the Importance of the Cold Chain in the Pharmaceutical Market

Written by Giovanna Cantoni | Jun 9, 2023 7:00:00 AM

Abstract

Shipping conditions, particularly the cold chain, play a significant role in the pharmaceutical industry. To abide by the strict regulations of the industry and ensure compliance, it is essential to maintain product quality from the raw material phase until final delivery. This article delves deep into the concept of Good Distribution Practice, which encompasses a range of activities associated with the distribution of pharmaceutical products, with a specific focus on shipping validation and its significance in what is commonly referred to as the cold chain field. This includes the qualification of trucks, temperature-controlled containers, and monitoring of critical variables such as temperature, relative humidity, shock, light, and position. Overall, this article emphasizes the need for risk-based approaches and thorough validation protocols for different routes, considering factors such as journey length, transportation media changes, climatic zones, and route complexity.