How is Annex 15 going to affect you?
Risk comes to the forefront
The revised version of Annex 15 of EU GMP enters into force from 1 OCT 2015. and all stakeholders must control the critical aspects of their operations through qualification and validation throughout a product’s life-cycle. Because of globalization GDP-compliant warehouses are needed throughout the world. All entities in the supply chain must show that temperature-sensitive products are being stored and transported appropriately. The new regulation covers the matters of validation and qualification of processes and equipment, but to us one of the most relevant parts is a new requirement of performing a RISK ASSESSMENT of the Transportation process.
As usual, World Courier aims to be ahead of the game and the QA department have prepared a thorough Risk Assessment documentation to help our clients achieve better compliance with the new requirements.
We have analysed all major risks associated with transportation and presented the risk mitigation measures that we have in place. The documents covers both air and ground transport and relates to general procedures, so can be applied to all shipments regardless of destination.
Your QA department or your Key Account Manager will be able to give you further guidance or contact Office of the Vice President, Global Quality & Technical Compliance