As a patient, you want to be certain that the quality of your medication remains unchanged throughout the chain of supply. How can you be sure that the pills that arrive at your hospital, your physician or pharmacist are identical to those shipped by the manufacturer? As an organization that is part of this chain of supply, you can ensure this by complying with the EU Guidelines for Good Distribution Practice of medicinal products for human use. Its focus: distribution, security, temperature control, packaging quality and reliable, functional technology.

Compliance with the GDP requirements is recognized proof of a company having successfully established the relevant controls in the supply chain; it is therefore able to deliver safe products of high quality in accordance with the requirements of pharmaceutical manufacturers. Implementing these requirements and having their effectiveness confirmed by an independent third party makes you a reliable business partner within the health care sector’s chain of supply. By consistently applying the Guidelines, and by responsibly handling medicinal products for human use, you set a competitive advantage, and you contribute to enhancing patient safety. GDP requires a well implemented and effective quality management system. Building on that, organizations can implement the specific requirements of the GDP Guideline with little effort.

There are many requirements for pharmaceutical products even after assembling and packaging. Medicinal products and excipients are usually distributed over long distances and through different climate zones, and are stored in various warehouses – overall, the distribution network is constantly getting more complex. In addition, the awareness of compliance with good storage, transport and distribution practices is growing globally. The EU Guideline on Good Distribution Practice (GDP) tightens the requirements for transport and logistics service providers. It also addresses pharmacies and wholesalers, as well as logistics providers operating in procurement, stock receipt, storage, shipping and transport.

Benefits of GDP Pharma certification

  • Significantly fewer individual customer audits
  • Higher degree of transparency and reliability in the supply chain
  • Noticeably fewer damages and loss
  • Increased legal certainty and improved reputation
  • Possibly lower insurance premiums due to recognition by insurers

Certification to GDP

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.

A certification body’s competence, professionalism, and customer orientation are of decisive importance for your sustainable success. The DQS certification process starts with getting to know each other and with an initial exchange of information to prepare a detailed offer. During the GDP audit, our sector-experienced auditors will analyze your procedures and processes as well as those of your partners in the supply chain. This ensures that you will continuously deliver high-quality services in accordance with the expectations of the pharmaceutical manufacturers.

The certificate is valid for three years, starting from the date of issue. After 12 months at the latest, and at least once per year, surveillance audits will be conducted. Recertification needs to be conducted before the certificate expires.

*For companies operating exclusively outside the EU, DQS also offers certification according to the Word Health Organization’s (WHO) Good Distribution Practices for Pharmaceutical Products” or United States Pharmacopeia (USP).

Source: DQS Holding GmbH

Summary

Good Distribution Practices (GDP) is a quality system for distributors of and logistic companies for medicines, such as warehouses and forwarders. Some National Pharmaceutical GDP regulations may require pharmaceutical products distributors to comply with such standards. Click here to learn more about Pharma GDP Certification.

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