GDP Certification Service

GDP Certification Service

What is GDP certification?

The abbreviation GDP stands for Good Distribution Practices and refers in this context to the storage and transport of finished medicinal products and active ingredients.

Manufacturers of pharmaceutical products are subject to the requirements of Good Manufacturing Practices (GMP). Manufacturer quality must be ensured throughout the entire supply chain. Even slight fluctuations in temperature and humidity can affect the life and mode of action of medicines. As valuable commodities, pharmaceuticals must also be protected from theft and the introduction of counterfeit drugs into the supply chain.

GDP certification covers areas of the product lifecycle of healthcare products, particularly human pharmaceuticals and active ingredients, that arise around storage and transportation activities. A GDP compliance audit examines the sum of requirements or measures in the distribution chain that ensure the quality and integrity of pharmaceuticals.

Advantages of GDP certification

A GDP certificate identifies your company as a competent and reliable partner for pharmaceutical logistics.

The issuance of GDP certificates is regulated differently in the federal states and is partly only issued to manufacturers and distributors. Federal presidia do not consistently issue certificates to logistics companies. However, pharmaceutical manufacturers and distributors are obliged to monitor their logistics service providers. Individual customer audits involve a great deal of effort for both sides.

With the GDP audit, GUTcert helps logistics service providers to improve their performance and to communicate good distribution practices to their customers. In doing so, we commit ourselves to apply the recognized rules from our accredited ISO processes to the compliance audits against the GDP guidelines.
Costs GDP certification

The costs for a certification according to GDP depend on the activities, the number of sites and the size of the workforce. We will be happy to provide you with an individual offer over a 3-year cycle.

Within the framework of integrated audits, synergies can be generated and audit time expenditures and thus costs can be reduced.
In addition to your certificate, you will also receive our digital certification marks following the audit, which you can use free of charge for your corporate communications.

 

Three years after (initial) certification, a recertification audit is carried out. In advance, we will provide you with an effort update.

Good Distribution Practices (GDP) Certification for Pharmaceuticals demonstrates your dedication to good distributive practices and quality in every aspect of your service.

 

Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. An independent assessment of compliance against international GDP requirements is the most effective way to establish that your quality management system aligns with GDP guidance.

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