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The questions distributors and manufacturers in regulated industries ask us most. Every answer starts with the core and then gets to the details, based on the official text.
Good Distribution Practice (GDP) is the EU standard for distributing medicines. The EU GDP guidelines set out how wholesalers source, store, transport and document medicinal products so that their quality and authenticity are preserved from the manufacturer to the pharmacy. They apply to every business that holds a wholesale distribution authorisation (WDA).
EU GMP Annex 11 is the annex of the EU Good Manufacturing Practice (GMP) guide that covers computerised systems. It requires you to validate every system that holds GMP-relevant data based on risk, record changes in an audit trail, control access and store data securely. Through the Good Distribution Practice (GDP) guidelines, the same standard applies in wholesale distribution.
GAMP 5 is a guide published by ISPE that regulated companies use to validate computerised systems based on risk. It is not a law, but inspectors accept it as a way to meet the validation requirement in EU GMP Annex 11. How deeply you validate depends on the GAMP 5 software category and on the risk of each function.
The ALCOA+ principles are nine criteria regulators use to judge the integrity of regulated (GxP) data. ALCOA stands for attributable, legible, contemporaneous, original and accurate. The plus adds complete, consistent, enduring and available. The FDA, MHRA, WHO and PIC/S all build on ALCOA+, in manufacturing and in wholesale distribution alike.
An audit trail is a software's change log. It automatically records who changed which value and when, what the old and new values are, and why. No one can edit it afterwards. EU GMP Annex 11 expects an audit trail for all data that matters for the quality of medicines, and through the Good Distribution Practice (GDP) guidelines this also applies in wholesale. You must review it regularly. In an inspection, the audit trail proves that no one has changed stock, batches or releases unnoticed.
The UDI-DI is the fixed part of the Unique Device Identifier (UDI) required by the EU Medical Device Regulation (MDR). It identifies the manufacturer and model of a medical device. The variable part, the UDI-PI, holds the batch, serial number or expiry date. Together they appear on the product as a barcode. In the EU database EUDAMED, the manufacturer registers the UDI-DI under a Basic UDI-DI. Distributors store the UDI of class III implantable devices so they can find every unit in a recall.
EUDAMED is the European database on medical devices, set up under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Manufacturers, authorised representatives and importers register themselves and their devices in it, and notified bodies record the certificates they issue. Four of its six modules have been mandatory since 28 May 2026, including actor registration and UDI/device registration.
NMVS stands for National Medicines Verification System: the national database that stores the unique codes printed on packs of prescription medicines. Together with the EU hub run by the European Medicines Verification Organisation (EMVO), the national systems form the EU verification network required by the Falsified Medicines Directive. Pharmacies and wholesalers scan a pack's code to check it against the NMVS and decommission it when the pack leaves the supply chain.
Computer system validation (CSV) is the documented proof that a computer system used in a GxP process does what it is meant to do, reliably and every time. GxP is the umbrella term for good practice rules such as GMP and GDP. The company that uses the system is responsible for validating it, to a depth that matches the risk to patients, product quality and data. Software suppliers contribute documentation and tests, but they cannot validate the system on your behalf.
21 CFR Part 11 is the US FDA regulation on electronic records and electronic signatures. It sets out when the FDA accepts electronic records and signatures as equivalent to paper records and handwritten signatures: the system must be validated, access limited to authorised people, every change captured in a secure, time-stamped audit trail, and each signature linked to its record. It applies to records that other FDA rules require you to keep or submit.
FEFO stands for First Expired, First Out: the stock that expires first leaves the warehouse first. Unlike FIFO (First In, First Out), what counts is not the date of receipt but the expiry date of each batch. That way, no stock sits on the shelf until it expires and has to be destroyed. For medicines, the EU Good Distribution Practice (GDP) guidelines require FEFO, and you must document any exceptions. An inventory management system enforces FEFO by automatically allocating the batch with the nearest expiry date at picking.
Temperature mapping is a documented study that shows how temperature is distributed across a storage area. You place calibrated data loggers throughout a warehouse, cold room or other store and record temperatures under representative conditions. The results prove whether every place where medicines might sit stays within the required range, and they show the warmest and coldest spots, where you then monitor permanently. The EU GDP guidelines require an initial mapping before a storage area is used.
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