GDP QUALITY MANAGEMENT
Give each warehouse decision a clear owner and a traceable record. Quality agreements, SOPs, training, stock-status control and deviation handling connect pharmaceutical goods receipt, storage, fulfilment and dispatch.
AT A GLANCE
GDP quality management defines the responsibilities, procedures, records and quality decisions that protect medicinal products throughout warehouse handling. Explore pharmaceutical warehousing for Germany →
The operating model identifies decision makers, required information, escalation contacts and cover arrangements. It separates the logistics provider's activities from the client's product and market responsibilities. Authorisation evidence and the scope of professional oversight are reviewed before operations start.
Receipt, storage, picking, dispatch, returns and recalls follow documented procedures. Staff training, retained records and change control support consistent execution. Changes to product profiles, zones or systems are assessed before they enter routine operation.
Unplanned events are recorded, assessed and investigated. Product impact, immediate containment, root cause and corrective or preventive actions are assigned to the appropriate functions. Temperature excursions require duration, measurement data and product limits to be considered before a stock-status decision.
Batch numbers, expiry dates, stock status and movement history support product tracing and recall-related stock blocks. Returns remain under a controlled status pending the required assessment. Serialisation or serial-number tracking is only included after technical and process confirmation.
Audit scope, timing and participants are agreed for the project. Site authorisations and GDP evidence are checked against the actual activities. Reviews use agreed quality indicators, deviations, CAPA, complaints and changes to identify where the operating process needs improvement.
FREQUENTLY ASKED QUESTIONS
No. The legal entity, site, evidence and authorised activity scope must be checked against the proposed project.
Returns are recorded separately and held under a defined stock status until the agreed assessment and responsible decision are completed.
Audit scope, schedule, evidence and participants are agreed for the individual project.
Not automatically. Serial-number processes require confirmed data, system capability, interfaces and an agreed activity scope.
REGULATORY BASIS
The process descriptions refer to the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01). Site, legal entity and authorised activity scope must be verified before project start through the competent authority and relevant EudraGMDP records. SÚKL is the national medicines authority for Czech sites.
English content updated: 11 October 2026 · Pharmaceutical contact: Martin Didunyk, licensed pharmacist.
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