EU GDPs (European Commission of Nov 2013, 2013/C 343/01) require that necessary storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging. However, the real-world processes of shipping and distributing medicines from the manufacturer to wholesaler to warehouses to the end user either via air, ship or car often expose the shipments to temperatures and humidity different from the label storage conditions. These temperature excursions from shipping and distribution conditions occur on a frequent basis - and this is a major concern for them. The Responsible Person (RP), or Qualified Person (QP), or Responsible Pharmacist (RPh) of a wholesale distributor and/or the QA personnel of a manufacturer are the first to confront these deviations and to implement a procedure of handling and investigating temperature excursions.
For instance, how would you handle a shipment that was exposed to a varying temperature up to 61oC in the airport for an accumulated duration of several days? How would you evaluate the quality of a refrigerated injectable that was exposed to near zero or freezing temperatures for a few hours? Would you release or reject such a shipment which may cost hundreds of thousands of Euros or may entail a local shortage of medicines?
EU GMP Annex 16 (2015) requires an evaluation of the potential impact of the temperature deviation on quality, safety or efficacy of the batch(es) concerned and conclusion that the impact is negligible. This regulatory document even calls for considering a placement of the affected batch(es) in an ongoing stability programme.
The course Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals in Berlin, Germany, on 24/25 September will provide you with a comprehensive overview of tools that a Qualified Person (QP), Quality Assurance personnel or a Product Manager/ Manufacturer should have to evaluate the impact of excursions from the storage label instructions on the disposition of distributed shipments of pharmaceutical/biopharmaceutical products. In particular these tools are for: