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What is GDP?

Good distribution practice, or GDP, is an international standard that sets out the minimum criteria which medicine wholesale distributors must adhere to. It is primarily used within EU nations, although the standard is recognised in several other countries as well. GDP helps ensure that the quality and integrity of medicinal products are maintained throughout the entire logistical supply chain.

Who needs GDP certification?

Unlike other industry standards, GDP is focused solely on distributors of medicines. As a result, its scope is fairly limited and this standard is of no real use to other industries. In fact, this standard does not even apply to medicine manufacturers, although there are several best-practices shared in both GDP and GMP.

Any business or enterprise operating in the whole distribution of medicinal products within the EEA must obtain authorisation issued by a national competent authority.

This includes importers and parallel distributors.All these entities must obtain GDP authorisation as proof that they meet the necessary legal obligations and follow the guidelines listed in this standard.

Good distribution practice outlines specific requirements which importers and distributors of active substances intended for the manufacture of medicinal products must adhere to. These businesses must also register with the competent authority located in the EEA country where business is carried out.

What’s GDP all about?

GDP has been developed to safeguard active ingredients and medicines when they are in transit or storage. This standard provides the minimum necessary requirements and checklists that relevant enterprises must adhere to. Compliance with these requirements is the responsibility of the national competent authority.

By complying with GDP, enterprises are ensuring that:

  • There is a consistent turnover of stored medicines
  • Medicines get to the right destination within a safe time slot
  • The likelihood of any contamination or degradation of medicines is extremely low
  • Medicines are stores in the appropriate conditions during all stages of transport and storage
  • All medicines transported and distributed to any EU or EEA country are authorised and regulated in accordance with EU laws

The GDP standard requires all distributors to have a reliable tracing system. In this way, faulty products can be quickly located and product recalls can take place efficiently and effectively.

Similar GDP requirements are set out for importers and distributors of pharmaceutical active ingredients, or any other ingredients used in the production of medicines.

The next step

If you would like to find out more about becoming GDP-certified, you should get in touch with us today.

One of our experts will be able to answer your questions and provide you with a thorough explanation of the entire process.

    Aries Ltd offers management systems assessment and certification services in compliance with international ISO standards for businesses, government bodies, and NGOs.

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