GDP Audit

GDP (Good Distribution Practice), as defined in the EU Guide, represents an essential component of the pharmaceutical quality system. Since 2013 the GDP guidelines for finished medicinal products (EU Guide of 5 November 2013 on Good Distribution Practice of medicinal products for human use) and, since 2015, also for active substances (EU Guide of 19 March 2015 on the principles of Good Distribution Practice of active substances for medicinal products for human use) have been in force. This has created a series of new requirements for audits.

The requirements of “Good Distribution Practice” or “GDP” for finished medicinal products concern everything between the manufacturer and the pharmacy. Our GDP audits deal with:

• Wholesalers
• Logistics providers
• Intermediate storage facilities

In addition, the GDP guideline for active substances concerns the entire supply chain from the manufacturer through to the medicinal product manufacturer. Audits here primarily concern:

• Logistics service providers responsible for proper transport
• Active substance traders

Our experts in the field of GDP can support you in the qualification and/or auditing of your GDP service providers. Our auditors specially qualified for Good Distribution Practice (GDP) have many years of experience in GDP audits. Renowned European carriers such as Trans-o-flex, TransMed, Hartmann and others have already been audited by us on multiple occasions.

Do you have logistics service providers in the Far East, for example in India, or abroad in general? This is where our solution comes into play, to save you travel and at the same time conserve resources: our Operation Units in the Asian region and in Europe are qualified and ready for your GDP audits.

The services provided by logistics service providers are often similar: transport of goods, intermediate storage, freight forwarding, cooling, etc. These similarities allow us to conduct the audits in the form of shared audits, which makes the execution more efficient. In such a case you receive a complete audit report together with comprehensive audit documentation at a fair price – of course, your individual questions and requirements are taken into account at all times during the audit and in the report.