EU Annex 9 – Pharma GMP

Log Environmental Conditions at Defined Intervals in GMP Warehouses

digi — Sun, 24 Aug 2025 12:04:18 +0000

Log Environmental Conditions at Defined Intervals in GMP Warehouses Record Environmental Conditions in Warehouses at Defined Intervals Remember: Always log temperature, humidity, and environmental data in GMP storage areas at defined intervals to ensure compliance and product quality. Why This Matters in GMP Environmental conditions in storage areas have a direct impact on the quality...

Avoid Temperature Excursions in Validated GMP Storage Areas

digi — Sat, 09 Aug 2025 15:49:50 +0000

Avoid Temperature Excursions in Validated GMP Storage Areas Preventing Temperature Excursions in GMP-Validated Storage Environments Remember: Never allow temperature excursions in validated storage areas — even short deviations can jeopardize product quality and violate GMP protocols. Why This Matters in GMP Pharmaceutical products are highly sensitive to temperature and humidity fluctuations. Validated storage areas are...