Exelsius launches pharma handling qualification
Exelsius has launched a pharmaceutical qualification programme (PQP) for companies involved in the handling and transportation of pharmaceutical & life science products.
December 23, 2014
By Denice Cabel
UK-based international cold chain management consultancy Exelsius has launched a pharmaceutical qualification programme (PQP) for companies involved in the handling and transportation of pharmaceutical & life science products. The firm says that its programme allows airports, freight forwarders and logistics service providers to become certified to Good Distribution Practice (GDP) standards. The PQP has been developed specifically for those involved in the air cargo cool chain and allows participants to demonstrate that they are compliant to the latest GDP regulations issued by the airlines, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the European Union and the US Food and Drugs Administration.
Exelsius chief executive Tony Wright says: “With over half of the value of healthcare products being moved by air, shippers will be seeking only the most compliant GDP logistics providers. This programme will be of initial importance in the UK where the MHRA have taken a lead in requiring airport ground handling companies, airlines and forwarders holding pharmaceuticals to have applied for a Wholesale Dealers Authorisation (WDA).”
With the Exelsius pharmaceutical qualification programme, organisations involved in good distribution practice can be ready to meet those requirements. The PQP programme includes a full facility assessment, compliance plans, quality management system & SOP development, vendor assessment, route qualification and a fully integrated and certificated training plan. The PQP requires participants to demonstrate compliance with all aspects of an initial gap analysis and training programme before certification will be granted. Reassessment will take place within two years.