The Problem & Knowledge Hub

Medical Products can lose their quality, safety, and effectiveness after manufacturing due to poor storage conditions, temperature excursions, humidity exposure, rough handling, and weak documentation. Scientific studies show that repeated exposure to temperatures outside recommended limits—even for short periods—can lead to chemical degradation, reduced potency, and shortened shelf life, even when products are within expiry dates. These risks often occur at warehouse, distributor, transport, and pharmacy levels, making GDP a critical safeguard beyond manufacturing compliance.

Global studies highlight that a significant portion of substandard medicines are not counterfeit, but genuine products that have degraded due to improper storage or distribution. Research published in leading medical journals links such degradation to treatment failure, antimicrobial resistance, and avoidable patient harm. This evidence reinforces that distribution quality failures can have the same clinical impact as manufacturing defects, making GDP compliance a public health necessity rather than a regulatory formality.

Temperature-sensitive products such as insulin, vaccines, biologics, and certain injectables are especially vulnerable to cold chain failures. Research published in peer-reviewed journals shows that 20–40% of cold-chain products experience temperature excursions during storage or transport. Exposure to excessive heat can reduce insulin effectiveness, while freezing can permanently damage vaccines—posing serious patient safety risks despite the products appearing normal. Many of these failures occur due to lack of monitoring, poor refrigerator practices, or untrained handling at distributor and retail levels.