A focus on patient safety
As a company concerned, you can ensure this with the EU Guideline on Good Distribution Practice for Medicinal Products for Human Use. In focus: distribution, safety, cold chain, packaging quality and reliable, functional technology.
Transparency and reliability in the supply chain
Reduction in damage and losses
Increased legal certainty and reputation
Reduction of customer-specific audits
What is GDP - Good Distribution Practice?
Compliance with the GDP directive ensures control of the distribution chain and thus maintains the quality and integrity of medicines. GDP requires a functioning quality management system, for example according to ISO 9001. In this way, companies can supplement the specific requirements of the GDP Guideline with little effort.
How does a certification according to GDP work?
First, we discuss your company's requirements and the goals of a certification together. Based on these discussions, you will receive an individual offer tailored to your needs.
These steps prepare the actual audit. A project planning meeting is useful for larger projects to plan schedules and conduct audits for individual sites or departments. A pre-audit helps identify strengths and areas for improvement in advance.
In the certification audit, our auditors examine your processes and methods as well as those of your supply chain partners. Emphasis within the process steps is on temperature control. For this purpose, not only technical equipment such as cold storage cells, sensor technology, mapping and monitoring, but also process safety, temperature documentation and emergency concepts are considered. In addition, the auditors examine the security of the goods in order to avoid theft or the exchange of goods. The results are presented in the final meeting and, if necessary, action plans are agreed upon.
After the GDP audit, the results are evaluated by our independent certification board. If all requirements are met, you will receive the certificate.
Annually, key components of the system are re-audited on site for further improvements. The GDP certificate is valid for three years. Before expiration, recertification is performed to ensure continued compliance.
What does GDP certification cost?
What you can expect from us
- Over 80 international offices
- Global presence, local service
- Customer and solution-oriented
Typical GDP Standards
- EU GDP Guidelines (2013/C 343/01)
- United States Pharmacopeia (USP 1079), and
- WHO GDP (World Health Organization TRS 957 Annex 5)
The Good Distribution Practices (GDP) guidelines are applicable to the storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to patients or their agents.
Requirements for Wholesale Distributors
According to Article 1(17) of Directive 2001/83/EC, a medicinal products wholesale distributor has to hold a wholesale distribution authorisation. Article 80(g) of Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for GDP. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.
Requirements for Logistic Service Providers
The EU GDP Guidelines include requirements for transportation and storage. EU Directive 2013/C343/01 requires that the contract giver is responsible for assessing the competence of the contract acceptor to successfully carry out the work required and for ensuring by means of the contract and through audits that the principles and guidelines of GDP are followed.
Audit & Certification
A GDP audit is based on a series of criteria, including quality control, employee training, security, inspection procedures, cleanliness of facilities, etc.
A certification against international GDP requirements with professional audits by a certification body will help you tackle the compliance with GDP guidelines with a systematic approach.