Protect pharmaceutical product integrity throughout the distribution chain with Good Distribution Practice compliance. QMICS helps wholesale distributors, 3PL providers, and manufacturers achieve and maintain GDP certification.
We evaluate your storage facilities for temperature control, security, pest management, and segregation requirements, ensuring warehouses meet GDP standards for pharmaceutical product storage.
We design pharmaceutical-grade temperature monitoring systems, conduct warehouse temperature mapping studies, and validate cold chain transport containers and vehicles for GDP compliance.
We develop GDP-compliant quality procedures covering goods receipt, storage, picking, dispatch, returns handling, complaints management, and falsified medicine prevention controls.
We prepare your documentation package and quality system for Wholesale Dealer Authorization (WDA) applications and regulatory GDP inspections by competent authorities.
GDP compliance is a legal requirement for wholesale distribution of medicinal products in the EU and many regulated markets. Our support ensures your WDA application is successful.
GDP systems prevent temperature excursions, counterfeit product infiltration, and improper handling that can degrade product quality and pose serious patient safety risks.
GDP documentation requirements provide end-to-end traceability enabling rapid, effective product recalls and falsified medicine investigations when required by regulators.
GDP-certified distributors are preferred partners for pharmaceutical manufacturers — opening access to more distribution contracts, brands, and high-value product portfolios.
A structured, proven approach delivering measurable results at every stage.
We review facilities, transport operations, IT systems, and quality procedures against EU GDP Guidelines 2013/C 343/01 and WHO technical requirements, documenting all compliance gaps.
We design temperature mapping studies, specify monitoring systems, and validate transport routes and packaging configurations for temperature-sensitive pharmaceutical products.
We implement GDP-required procedures for all distribution activities including goods receipt, storage, picking, dispatch, returns, supplier qualification, and contracted activities management.
We train all GDP-relevant staff and provide ongoing coaching for your Responsible Person (RP) on GDP obligations, regulatory interactions, and quality decision-making responsibilities.
We prepare your WDA application, conduct mock inspections, and support your team through the competent authority GDP inspection and post-inspection CAPA activities.
Contact our experts today for a free consultation tailored to your organization.