If you are looking for a partner in the field of GDP, you have come to the right place at PCS.We help clients to achieve the desired quality. We do this by providing training, advising and carrying out checks. You can also contact us for GDP licenses. With this we guarantee that your company complies with GDP laws and regulations.
For Pharma & Biotech
Good Distribution Practices (GDP), are regulations that apply to the distribution of medicines. These legal requirements have been published by the European Commission. A pharmaceutical wholesaler must ensure that the quality and integrity of pharmaceuticals is maintained throughout the supply chain.
A wholesaler of medicines must have a Wholesale Distribution License (WDL), in order to be allowed to distribute medicines. In order to be able to apply for a license as a wholesaler, this wholesaler must comply with GDP regulations.
Medicines are produced to the highest standards and distribution should be a walk in the park. “What could go wrong?” you might think. Unfortunately, there have been many instances of confusion in the pharmaceutical chain over the years. This necessitates stricter regulations.
In order to maintain the original quality of pharmaceutical products, every party active in the pharmaceutical distribution chain must comply with the applicable GDP laws and regulations. Every activity in the distribution of pharmaceutical products must be carried out according to the GDP principles.
Companies choose the GDP services of PCS for training, certification and construction of their warehouse.
Training for the pharmaceutical branch of DHL Logistics.
GDP inspection preparation for Mallinckrodt.
GDP training for all staff of GDP distributor Polar Special.
PCS supports drug distributors with;
Implementing GDP requirements,
submitting the wholesale license application,
GDP inspection preparation,
upgrading the GDP quality system,
Interim Responsible Person (RP) services.
Customers choose PCS because of our extensive experience in the field of GDP regulations. Time always plays a role in our projects. We know how the authorities work and what they expect. In this way we help our customers to obtain a Wholesale Distribution License (WDL) on time and within budget.
Our GDP training certificates are widely accepted by both logistics companies and authorities. Thanks to our team of experienced consultants and ex-EU GDP inspectors, we can perform an accurate pre-inspection and provide GDP audits to pharmaceutical wholesalers.
Maintaining or upgrading GDP can be quite a challenge. You will not achieve it with quick fixes. Due to COVID-19, there are significantly stricter requirements for submitting WDL applications. We are happy to advise and help you navigate the regulatory hurdles successfully.
Our experienced GDP consultants dive into your company and provide advice on everything related to GDP. Our team consists of experienced consulates and ex-government inspectors who know exactly what the government wants to see. This allows projects to be handled faster and more accurately.
We also have a diverse and especially global experience in the field of GDP. With this international experience we are able to tackle the more difficult projects; doing business internationally makes flexibility a necessity.
The basic principle for GDP regulation is the maintenance of quality from producer to customer. This means that other parties in the distribution chain, such as a transporter and a forwarder, must also comply with GDP regulations to guarantee the quality and integrity of the medicines. In addition, the entire chain is responsible for guaranteeing that the medicines that patients use are also of good quality!
In the past year, PCS has already helped many companies to implement or upgrade their GDP standards in order to obtain/renew a Wholesale Distribution License (WDL).
PCS provides two types of GDP training:
Good Distribution Practices (GDP): A two day course on GDP regulation. This course is intended for the (future) responsible persons (API), logistics managers (supervisor) and Qualified Persons, (QA).
GDP for warehouse workers: A short course on GDP regulations with real-life examples. In this course you will learn all about GDP requirements, why they exist and what documentation is involved. This course combines theory and practice to give you a good understanding of the basic principles of GDP.
We are a pharmaceutical consultancy dedicated to quality and patient safety. Do you have a GDP quality or regulatory problem, are you looking for a GDP certificate or clear GDP training? We have the expertise and experience to resolve it decisively and quickly.
Feel free to contact us if you have any questions about our offer or GDP in general.