Pharma logistics

This is not a legal term. The EU GDP guidelines speak of wholesale distribution instead, quoting its definition from Article 1(17) of Directive 2001/83/EC: all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying them to the public. Their glossary defines transport as moving medicinal products between two locations without storing them for unjustified periods of time. The GDP GDP Good distribution practice (GDP) is the part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain. Read in the glossary → definition covers the supply chain stages from the manufacturer's site to the pharmacy or person authorised or entitled to supply medicinal products to the public.

Two points in the guidelines are relevant to logistics providers. First, the introduction says other parties involved in distribution should follow relevant sections, without saying which. Second, section 1.3 says the quality system should extend to the control and review of outsourced activities. Chapter 7 adds that these should be correctly defined, agreed and controlled, and that the contract giver is responsible for the activities contracted out. A transport contract with a third party should include the requirements of Chapter 7.

One of our long-standing customers is a pharma logistics provider. We have seen proofs of delivery arrive from several carriers in different formats, leaving someone to re-type the data into the next system. Our software for such cases connects to the enterprise resource planning ERP ERP (enterprise resource planning) is cross-departmental business software that manages and analyses processes such as production, sales, logistics, finance and human resources. Read in the glossary → (ERP) system or WMS WMS WMS stands for warehouse management system; according to the short description of VDI 3601, its task is to manage and optimise a company's internal storage and transport systems. Read in the glossary → already in place.