GDP Consultancy Services for the Pharmaceutical Industry

If you are looking for a partner in the field of GDP, you have come to the right place. PCS helps clients to achieve the desired quality. We do this by providing training, advising and carrying out checks. You can also contact us for WDA licensing. With this we guarantee that your company complies with GDP laws and regulations.

What is GDP?

Good Distribution Practices (GDP), are regulations that apply to the distribution (and storage) 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 Authorization (WDA), 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.

Why do wholesalers have to comply with GDP?

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 mix-ups in the pharmaceutical supply chain over the years. This necessitates strict quality regulations, as patient safety could be seriously impaired by mix-ups.

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.

What GDP services does PCS offer?

PCS supports pharmaceutical wholesalers with;

• Implementing GDP requirements,

• Preparing and submitting the license application,

• GDP inspection preparation,

• Upgrading or implementing the GDP quality system,

• Interim Responsible Person (RP) services.

Clients 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 in the Netherlands to obtain a Wholesale Distribution Authorization (WDA) 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.

What do we want to achieve with the GDP regulations?

1. Medicines in the supply chain are authorized in accordance with European Union (EU) legislation;

2. Medicines are kept under the right conditions at all times, including during transport;

3. Contamination by or from other products is avoided;

4. An adequate circulation of stored medicines takes place;

5. The right products reach the right consignee within a satisfactory time frame;

6. Preventing counterfeit medicines from being put into circulation.

GDP consultancy

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 WDA 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.

GDP certification

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 Authorization (WDA).

GDP training

PCS provides two types of GDP training:

1. Good Distribution Practices (GDP) - for the Responsible Person: A two day course on GDP regulation. This course is intended for the (future) responsible persons (API), logistics managers (supervisor) and Qualified Persons, (QA).

2. GDP Refresher: 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.