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Dokumeds Passes GDP and ISO Surveillance Audits

May 26, 2021

ISO 9001:2015 certification shows a company’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.\(^1\)

That’s why we are happy to announce that we have recently passed surveillance audits for our ISO 9001:2015 certification for both “International Project Management for Clinical Research and Development of Pharmaceutical and Biotechnology Products” on a corporate level and our local warehouse in Russia - in the scope of “Storage and Logistics of Medicinal Products and other Materials for Clinical Studies.”

Yet another highly regarded industry standard for which we recently successfully passed the respective surveillance audit in our Russian warehouse is Good Distribution Practice (GDP).

GDP applies to medicinal products for human use, including Investigational Medicinal Products (IMPs). According to the European Medicines Agency (EMA), compliance with GDP ensures that:

  • medicines are stored in the right conditions at all times, including during transportation;
  • contamination by or of other products is avoided;
  • an adequate turnover of stored medicines takes place.\(^2\)

We are committed to quality in clinical trials and regularly participate in external audits, as well as conduct internal ones to ensure compliance with the latest industry standards. 

If you're interested in discovering the value that Dokumeds can bring to your clinical trials - get in touch!

Take a look at our certifications here:

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References:

  1. https://www.iso.org/standard/62085.html
  2. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/good-distribution-practice

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