Good Distribution Practice (GDP)

Good Distribution Practice (GDP) describes the minimum standards that wholesale distributors must meet to ensure medicines maintain their quality and integrity throughout the supply chain, from manufacturing facility to dispensing point. GDP encompasses the systematic controls, documentation, and quality management practices required to prevent product degradation, contamination, counterfeiting, or diversion during warehousing, transportation, and handling. It ensures that medicines are consistently stored, transported, and handled under suitable conditions, as required by regulators such as the European Medicines Agency (EMA) and the World Health Organization (WHO). IATA CEIV and ISO 21973 provide aligned frameworks that encompass or exceed pharmaceutical standards for air cargo operations.

A Kuehne + Nagel facility maintaining GDP certification must demonstrate temperature mapping of storage areas and validated packaging for pharmaceutical shipments on AWB 180-45678921 (Kuehne + Nagel's AWB prefix). Pharmaceutical air freight requires strict temperature ranges: +15 to +25 degrees C for controlled room temperature (CRT) products, +2 to +8 degrees C for refrigerated products, and -20 to -70 degrees C for frozen products like certain vaccines. A Brussels Airport (BRU) cargo terminal with CEIV Pharma certification provides GDP-compliant cold chain infrastructure for handling temperature-sensitive biologics shipped by Emirates SkyCargo on AWB 176-12345678.

• GDP
• pharmaceutical GDP
• WHO GDP
• EU GDP guidelines
• GDP certified

What are the specific temperature ranges required for Good Distribution Practice (GDP) compliance in air cargo?

Pharmaceutical air freight requires strict temperature ranges: +15 to +25 degrees C for controlled room temperature (CRT) products, +2 to +8 degrees C for refrigerated products, and -20 to -70 degrees C for frozen products like certain vaccines. Any deviation must be documented per GDP standards.

How does IATA CEIV Pharma certification relate to Good Distribution Practice (GDP) requirements?

CEIV Pharma encompasses, or even supersedes, many of the existing pharmaceutical standards and guidelines, safeguarding product integrity while addressing specific air cargo needs. The Centre of Excellence for Independent Validators certification program ensures GDP compliance across all airfreight supply chain processes. The process requires training of minimum 2 staff members in Temperature Controlled Cargo Operations and Audit, Quality and Risk Management for Temperature Controlled Cargo.