Good Distribution Practice (GDP) audit
The Good Distribution Practice (GDP) for medicinal products and active pharmaceutical ingredients (APIs) is a regulation developed to ensure that storage and transport preserve quality, integrity and efficacy of a medicinal product until it reaches the final selling point. Manufacturers of medicinal products and APIs are accountable to ensure that every step, from production to final distribution, is compliant with a set of market, legal and regulatory requirements.
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 minimised. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver.
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 available online 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.
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