GDP audit
Essential component of the pharmaceutical quality
system
GDP (Good Distribution Practice), as defined in the EU guidelines, is an essential component of the pharmaceutical quality system.
The GDP guidelines for finished medicinal products (EU guidelines of November 5, 2013 on good distribution practice for medicinal products for human use) have been in force since 2013 and since 2015 also for active substances (EU guidelines of March 19, 2015 on the principles of good distribution practice for active substances in medicinal products for human use).
This has created a number of new requirements for audits.
The requirements of “Good Distribution Practice (GDP)” for finished medicinal products affect everything between the manufacturer and the pharmacy.
Our GDP audits deal with:
- Wholesalers
- Logisticians
- Temporary storage
In addition, the GDP guideline for active substances affects the entire supply chain from the manufacturer to the pharmaceutical manufacturer.
Audits are primarily concerned here:
- logistics service providers, who in turn are responsible for proper transportation and
- Active ingredient dealer
Our GDP experts can support you with the qualification and/or auditing of your GDP service providers.
Our auditors, who are specially qualified for Good Distribution Practice (GDP), have many years of experience in GDP audits.
Well-known European freight forwarders such as Trans-o-flex, TransMed, Hartmann and others have already been audited by us several times.
Find out more about our comprehensive audit overview here.
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 conserve resources at the same time: Our operation units in Asia and Europe are qualified and ready for your GDP audits.
The services provided by logistics service providers are often similar: transportation of goods, temporary storage, shipping, refrigeration, etc. These similarities allow us to carry out the audits in the form of shared audits, which makes the process more efficient.
In such a case, you will receive a complete audit report (of course, your individual questions and requirements will be taken into account at all times during the audit and in the report) including comprehensive audit documentation at a fair price.
Do not hesitate to contact us at audit@heacon.de to find out more about our shared audits.
Would you like to audit a logistics service provider?
Visit our pharma-audit web appto order your next GDP audit and know that you are in the best possible position when it comes to distribution safety.
