Scope of Good Distribution Practice

Developed by the European Medicine Agency (EMA) for medicinal products in 2013, and for APIs in 2015, GDP guidelines are adopted by international regulatory agencies and guidelines, including IPEC excipients. GDP, among other pillars, places high focus on two areas around transportation and storage: 

• Temperature: all products should be stored and handled according to the temperature conditions labelled along the whole supply chain
• Qualification: facilities and equipment in the operation should be qualified  

Requirements of Good Distribution Practice

GDP consists of below main scopes that outline specific details of requirement for both medicinal products and APIs/excipients: 

• Quality management
• Personnel
• Premises and equipment
• Documentation
• Operations
• Complaints
• Self-inspection
• Transportation 

Good Distribution Practice audit by Eurofins

Globally pharmaceutical supply chain can work with Eurofins to run on-site GDP audit to demonstrate compliance in documented evidence. At the audit, our well-trained GDP auditors will conduct document review, interviews with personnel, and observe procedures to assess performance against GDP requirements. Upon completion of audit, customers will receive their audit reports with detailed findings and CAPAs, if any. 

Why choose Eurofins for your GDP audit?

We possess over 25 years of experience in the pharmaceutical and healthcare industry, supporting customers around the world on their compliance journeys. Our global network of auditors allows us to respond to your requests swiftly with travel costs and time minimized. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver. 

Our GXP audit is accredited for ISO 9001, showcasing our commitment and achievement to quality excellence!

In addition to on-site audit services, thanks to our expertise, we can deliver training and advisory services to better support customers who need extra help in reaching compliance goals. Shared GxP audits and purchase of GxP audit reports are both to offer fast and streamlined experience. 

When working with us, our professional and customer-centric teams assist you along your GDP audit, and provide your GDP audit reports on time. 

Auditing activities are compliant with international regulations such as EU, US, Brazilian, Canadian, and more. 

Our certification activities are provided by independent Certification Bodies, separately from any consulting activities. Impartiality is safeguarded by Eurofins Assurance’s relevant policies to avoid conflicts of interest.