Häufig gestellte Fragen
What does GDP (Good Distribution Practice) mean?
GDP stands for "Good Distribution Practice" and refers to the legally binding good distribution practice for medicinal products that governs quality-assured procurement, storage, transport and delivery along the entire distribution chain. In the EU, the governing rules are the "Guidelines on Good Distribution Practice of medicinal products for human use" (2013/C 343/01), which are based on Articles 84 and 85b of Directive 2001/83/EC and implemented in Germany through the German Medicines Act (Arzneimittelgesetz, AMG) and the Ordinance on the Wholesale Trade in Medicinal Products (AM-HandelsV). The goal is to safeguard the quality and integrity of a medicinal product without gaps from the manufacturer to the dispensing point. The abbreviation GDP should not be confused with the macroeconomic term Gross Domestic Product.
Who must comply with GDP?
GDP applies to all wholesalers of medicinal products for human use in the EU, i.e. every company that procures, stores, imports, exports or distributes medicinal products without manufacturing them itself or dispensing them directly to patients. In Germany, a wholesale authorisation from the authorities is required for this under Section 52a AMG, and compliance with the GDP principles must be demonstrable. Manufacturers, by contrast, fall under Good Manufacturing Practice (GMP) and pharmacies under the German Pharmacy Operating Regulations (Apothekenbetriebsordnung, ApBetrO); brokers and logistics service providers also bear a share of GDP obligations. The specific implementation varies in practice depending on the product range, company size and degree of customization of the ERP setup in use.
What temperature requirements does GDP impose on storage and transport?
GDP requires that medicinal products be stored and transported at all times within the temperature ranges approved by the manufacturer; typical specifications are 2–8 °C for products requiring refrigeration and 15–25 °C for controlled room temperature. Before a warehouse is used for the first time, a temperature mapping study must be conducted to identify the warmest and coldest points and to place sensors at the critical locations. Ongoing monitoring must be documented, and if the cold chain is interrupted, a risk assessment of the affected goods must be carried out. An ERP system supports this operationally by recording temperature histories and automatically posting batches with deviations to blocked stock.
What role does the Responsible Person play in GDP?
Under the GDP guidelines and Section 52a AMG, every pharmaceutical wholesaler must designate a Responsible Person who ensures compliance with distribution practice and oversees releases, recalls and the quality management system. The EU guidelines describe a university degree in pharmacy as desirable but do not make it mandatory. In 2020, the German Federal Administrative Court (case numbers 3 C 7.19 and 3 C 9.19) clarified that no pharmaceutical training is required for the role and that the necessary expertise can also be acquired through professional experience and training. The Responsible Person must carry out their duties personally and maintain their GDP competence through regular continuing education.
How does GDP differ from GMP and GLP?
GDP, GMP and GLP belong to the family of GxP quality standards but cover different phases of the product life cycle. Good Laboratory Practice (GLP) concerns non-clinical, primarily preclinical research and safety testing. Good Manufacturing Practice (GMP) governs the quality-assured manufacture of the medicinal product, while GDP covers exclusively the subsequent distribution, i.e. procurement, storage, transport and delivery of the finished product. GDP thus picks up where GMP ends and ensures that the quality achieved in production is not compromised on its way through the supply chain.
How does an ERP system support GDP compliance?
An ERP system is the operational hub for many GDP requirements because it handles batch and serial number management, expiry date control according to FEFO (First Expired, First Out), blocked stock and audit-proof logging of all goods movements. Via an audit trail, it documents in a traceable way who changed which data and when, and in the event of a recall it can specifically identify the recipients of an affected batch. In addition, temperature monitoring interfaces and status checks for suppliers and recipients can be integrated, and for international markets electronic signatures and access control modelled on 21 CFR Part 11 are frequently required. The system in use must be validated (Computer System Validation) and its configuration documented in a traceable manner; however, it replaces neither the legal authorisation nor the Responsible Person.