Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Enhancing GDP Compliance Through Certification

Jan 30, 2017

Temperature excursions and delays at airports are major concerns for companies shipping temperature-sensitive pharmaceutical products by air. In light of this, last fall, the International Air Transport Association (IATA) presented their Center of Excellence for Independent Validators (CEIV) certification program to the European steering committee of PDA’s Pharmaceutical Cold Chain Interest Group. IATA represents 265 airlines that account for approximately 83% of total air traffic. The CEIV certification program was developed in 2014 as part of an effort to harmonize the air transport industry’s practices for shipment of pharmaceutical product and accommodate the pharmaceutical industry’s GDP expectations. This program emphasizes the importance of having defined quality and risk management systems in place to address requirements coming from global regulators. IATA intends to provide the pharmaceutical manufacturing industry a harmonized standard for handling and transporting healthcare products worldwide through a network of CEIV-certified airlines, airports, ground handling agents, trucking companies, and forwarders.

The interest group’s European steering committee welcomes this initiative as a valuable effort in the joint quest of the airline and pharmaceutical industries to deliver safe healthcare products to patients. This program intends to deliver quality and risk management systems in the logistics industry designed according to mainstream GDP regulatory documents (MHRA, USP, EMA). Considering the increase in the complexity of the pharmaceutical supply chain, a network of CEIV-certified suppliers would undoubtedly enhance controls and visibility throughout the air freight industry.

More information about the program can be found here.

Conversations

comments powered by Disqus