GDP License and GDP certification

Services in accordance with the International GDP 2013/C 343/01 Regulations

Certification Experts can guide you in obtaining the GDP license and the compliance certificate by means of setting up a GDP Quality Management System (QMS). Additionally, our knowledge and (field) experience allows our GDP-experts to precisely gauge what your wholesale needs and we offer appropriate tools to assist wholesale distributors in conducting their activities in the distribution of medicinal products within the EEA, and training of your Responsible Person.

GDP-License-GDP-certification-Services-International-GDP-2013C-34301-Regulations
Summary

A quick overview of this page

GDP meaning: Good Distribution Practice

The guidelines on Good Distribution Practice of medicinal products for human use are related to the safety and legality of the distribution of medicinal products. The implementation of this standard is inspected by the Health and Youth Care Inspectorate (IGJ) and states that you, as a wholesaler of medicinal products, must guarantee the quality of the medicine, during and after the distribution, for the users. Distribution of medicinal products refers to all activities consisting of procuring, holding, supplying or exporting medicinal products. Without a GDP license, you are not legally allowed to trade medicinal products within the European Economic Area (EEA).

Challenges GDP

A GDP-license can be obtained by demonstrating compliance with the GDP guidelines. The wholesale distributor must designate a Responsible Person (RP). The RP is responsible for the implementation of the GDP guidelines and must ensure that the guidelines remain met. The RP should have had training and thus appropriate competence, experience and knowledge of GDP in order to fulfil their role. Once you have been given the GDP license, you can start with GDP activities. Obtaining the certificate will depend on the implementation of a suitable GDP Quality Management System (QMS), applicable to the distribution of medicinal products.  

Guidance from start to finish

To ensure that you meet all the requirements, we will help you implement a suitable and complete GDP QMS. Additionally, we will perform internal audits to verify the compliance. We will train and support your RP, help you with temperature mapping, and set up a risk assessment for your GDP processes. Our (field) experience and expert knowledge will allow us to ensure that you will acquire the GDP license and eventually GDP-certificate, so you can safely trade your medicinal products within the EEA.

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GDP License and GDP certification

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What is GDP?

GDP is an abbreviation of Good Distribution Practice and refers to the EU-guidelines that have been created to ensure the product safety and product quality of medicinal products within the full supply chain, from manufacturer to patient, and to prevent counterfeit products. As a wholesale distributor of medicinal products, you are also responsible for realising a safe distribution process. To achieve this, you will have to meet the GDP requirements of medicinal products for human use. The full requirements and obligations are listed in the GDP-guideline 2013/C 343/01. Whether you are in full compliance with these regulations is inspected by the IGJ (Health and Youth Care Inspectorate). If you can prove your compliance during the IGJ- inspection, you will obtain a GDP license. From this moment forward, you are allowed to trade medicine within the EEA.

From a wholesale license to a GDP-certificate

The GDP-guidelines make it mandatory for wholesalers to assign a Responsible Person (RP) from the moment the company applies for the license. The RP bears the responsibility to guarantee that the wholesaler adheres to the applicable legislations and GDP-guidelines whilst you carry out your GDP activities. The RP needs to have full knowledge of GDP. The wholesaler should give the RP the defined authority, resources and responsibility needed to fulfil the duties. The RP may delegate (parts of) their duties but may not delegate responsibility. We can support your RP in the execution of their GDP related tasks.

Ensure and maintain your Quality!

GDP-process

The process of obtaining GDP-compliance is a process that can only be executed in practice. We can help you acquire your GDP-certificate in 5 steps:

  1. The GAP-analysis: The cost, time and tasks of the process can differ for each wholesaler. Performing a GAP-analysis, we will identify what needs to happen, what concerns there are, how long it will take and how much it will cost, so that you know exactly what lies ahead
  2. Implementation GDP-QMS: A GDP Quality Management System will indicate that the product safety and quality of the medicinal product is consistently protected, from manufacturer to patient, and prevents counterfeit products being traded. We can help you to set up and implement a suitable GDP-QMS to ensure that you meet all the requirements
  3. Internal audit: We perform an internal audit to check whether you are in compliance with the relevant GDP-guidelines and whether the processes of the QMS are being performed correctly. This way, you will be well prepared for the inspections by the IGJ
  4. Management review: The management review is performed directly after the internal audit, in which the management reviews the effectiveness of the QMS and decides the output requirements for improvement
  5. Inspection: The last step is the inspection by the IGJ. You will be inspected based on the implementation and execution of the GDP requirements. Our consultant can support you during this inspection, so we can help you answer all questions concerning the QMS

With a GDP-license, you are allowed to distribute medicinal products at all times, provided that this happens in compliance with your license. It is important to know that you cannot request for a GDP compliance certificate yourself. The certificate is granted only on the basis of an IGJ inspection for wholesalers with a GDP-license. The IGJ determines risk based, when which company will be inspected. Usually, this occurs 1-2 years after obtaining the GDP license.

GDP & FMD

In addition to having to take the GDP-guidelines into account, European legislation was introduced in February 2019 for prescription medicines (UR): Falsified Medicine Directive (FMD). These guidelines are intended to prevent counterfeit medicinal product from entering the production and supply chain. Since this date, every package of UR-medicine must bear two safety marks:

  • A unique 2D matrix code
  • Anti-Tamper Device (ATD)

Manufacturers must upload all 2D matrix information about their medicinal products to a European database: the EMVS (European Medicine Verification System). The unique 2D matrix codes that are applied onto the packaging are being verified in the NVMS (National Medicine Verification System) by every party in the supply chain so that medicinal products are traceable. The national database and the European database are linked.

ATD is intended to ensure that packages have not been opened during distribution and thus prevent falsification of medicinal products. As a party within the supply chain, you need the resources (NVMS, scanning equipment and procedures) to be able to comply with FMD regulations. We can prepare and guide you through this process.

I obtained my GDP-compliance certificate: now what?

Once you have obtained your GDP-compliance certificate, you can continue executing the GDP-activities. The GDP-certificate is valid for a maximum of 5 years. In a few instances, this may be shorter (risk based). To be able to ensure that the safety is consistently guaranteed and that the GDP-QMS remains up to date, new inspections will be held after this time period so you can maintain your certification. If you are no longer in compliance with the legislation after this period, the IGJ might have to take appropriate measures. This can vary from drawing up a CAPA-improvement plan that must be solved within an agreed time; a written warning or an administrative fine; or withdrawing/putting your GDP license on hold. Simultaneously, your activity can be instantly called to a halt and/or your medicinal product might be taken out of the trade immediately. You obviously want to prevent this from happening, which can be achieved by maintaining your QMS properly. Certification Experts can help you to set up and maintain a suitable GDP QMS. This way, you will remain in compliance with GDP for every inspection or audit.

Portfolio

Check out our GDP services

GDP 

GDP is an abbreviation of Good Distribution Practice and refers to the EU-guidelines that have been created to ensure the product safety and product quality of medicinal products within the full supply chain, from manufacturer to patient, and to prevent counterfeit products. To ensure that you meet all the requirements, we will help you implement a suitable and complete GDP QMS. Additionally, we will perform internal audits to verify the compliance. We will train and support your RP, help you with temperature mapping, and set up a risk assessment for your GDP processes. Our (field) experience and expert knowledge will allow us to ensure that you will acquire the GDP license and eventually GDP-certificate, so you can safely trade your medicinal products within the EEA. 

  • GDP GAP Analyse 
  • GDP QMS
  • Wholesale License
  • Temperature Monitoring 
  • Management Review 
  • Self-Inspections/Internal Audits 
  • Training 
  • Guidance for IGJ Inspection 
  • Role Responsible Person

GDP QMS

Certification Experts can set up, implement, review and maintain a Quality Management System (QMS) for your organisation based on the GDP requirements. We provide an appropriate QMS based on your situation and wishes.

  • GDP QMS
  • Update of QMS
  • Maintenance QMS

Wholesale License

A Wholesale License for Good Distribution Practices (GDP) is a regulatory authorization or permit that is typically issued by government health agencies or regulatory bodies to wholesalers and distributors involved in the distribution of pharmaceuticals, medical devices, and related healthcare products. This license ensures that the wholesale distribution of these products adheres to specific quality and safety standards to safeguard the integrity and efficacy of healthcare products as they move through the supply chain. 

  • GDP Licences
  • Maintenance GDP Licence
  • Check application form

Temperature Monitoring

Part of the GDP is implementing temperature monitoring devices, such as data loggers and real-time monitoring systems, to continuously track temperature conditions during storage and transportation. These devices should be calibrated and validated regularly. Before starting operations, it’s important to conduct temperature mapping studies of storage areas and transportation vehicles. This involves placing temperature sensors at various points to ensure that the entire area maintains the required temperature range consistently.

  • Temperature Mapping
  • Temperature Records
  • Develop Standard Operating Procedures (SOPs) 
  • Training

Internal Audit

Our team of experts can provide aid via the Testing of your management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit.

  • Internal Audit

Management Review

Certification Experts will support the management in assessing the effective operation of the quality management system and help identify opportunities for improvement and risks.

  • Management Review

Training GDP

Training in Good Distribution Practice (GDP) is crucial for individuals and organizations involved in the distribution of pharmaceutical products to ensure that products are handled, stored, and transported in a manner that maintains their quality, safety, and efficacy. GDP training is typically a regulatory requirement in many countries and regions. Certification Experts have experts who are able to provide a GDP-training.

  • GDP training and exam
  • Internal RP basic training

Guidance for IGJ Inspection 

The ultimate goal of an IGJ Inspection is to verify that pharmaceutical distributors and wholesalers are following the established GDP guidelines to maintain the quality, safety, and integrity of medicinal products. Non-compliance can lead to regulatory actions, including warnings, fines, suspension, or revocation of licenses, depending on the severity of the violations. Certification Experts can facilitate the process to ensure the inspection goes smoothly. 

  • Guidance for IGJ Inspection

Responsible Person (RP) GDP

Certification Experts can offer to act as a Responsible Persons and will focus on helping pharmaceuticals fulfil their regulatory responsibilities and ensure that pharmaceutical products are distributed in compliance with GDP standards. These services are essential for maintaining the quality, safety, and efficacy of medicinal products as they move through the supply chain.

  • Set-up roles of RP and Deputy RP
  • RP service
  • Deputy RP service       
  • Guiding RP and/or Deputy RP                                                                                                 
Frequently asked questions

All the answers you might need!

Implementing Good Distribution Practice (GDP) practices and services in the pharmaceutical industry offers numerous benefits to companies. These include compliance with regulations, enhanced product quality, risk mitigation, improved traceability, operational efficiency, increased market access and reputation, global market expansion, customer trust, potential cost savings, and a competitive advantage. Overall, GDP practices contribute to the long-term success, sustainability, and credibility of pharmaceutical companies.

Good Distribution Practice (GDP) compliance in the pharmaceutical industry involves adherence to specific guidelines to ensure the quality and integrity of medicinal products during distribution. Key components include the implementation of a robust Quality Management System (QMS), personnel training, premises and equipment standards, meticulous documentation, temperature control and monitoring, supplier qualification, traceability systems, security measures, proper transportation practices, handling of returned products, and procedures for managing complaints and recalls. Continuous improvement through regular reviews and audits is essential for maintaining GDP compliance.

Non-compliance with Good Distribution Practice (GDP) regulations in the pharmaceutical industry can result in serious consequences, including compromised product quality, legal actions, product recalls, loss of licenses or authorizations, damage to reputation, supply chain disruptions, increased regulatory scrutiny, financial impact, and potential harm to patients. Adhering to GDP guidelines is crucial for ensuring the safety and effectiveness of pharmaceutical products, maintaining regulatory compliance, and safeguarding the reputation and viability of pharmaceutical companies.

The GDP (Good Distribution Practice) guidelines pertain to the safety and legality of the distribution of medicinal products for human use. This European standard is under the supervision of the Healthcare and Youth Inspection (IGJ) and mandates that, as a distributor of medicinal products, you ensure that the quality of the medicines remains intact throughout the distribution process for end users. This is ensured through requirements concerning the procurement, storage, sale, and logistics of the medicinal products. Without a GDP license, you are not legally allowed to trade medicinal products within the European Economic Area (EEA).

GDP is essential in the pharmaceutical industry to ensure the safety of patients, comply with regulations, maintain product quality, enable traceability, prevent counterfeiting, build public trust, and facilitate global trade in pharmaceutical products.

A Quality Management System (QMS) is a structured set of activities and processes that an organization establishes to manage and enhance the quality of its products or services. It involves key elements such as a quality policy, objectives, documentation, process management, risk mitigation, continuous improvement, and a focus on customer satisfaction. The QMS aims to meet customer requirements consistently and can be certified based on international standards like ISO 9001, tailored to specific industries such as medical devices (ISO 13485), or automotive (ISO/TS 16949). The system involves regular audits, training, and a commitment to ongoing improvement to ensure effectiveness and compliance with established standards.

Certification Experts provides a range of QMS services tailored to the medical device industry, covering areas such as Article 10 MDR, ISO 9001, ISO 13485, and Good Distribution Practice (GDP) Quality Management Systems (QMS).

If your organization is a wholesale distributor or manufacturer of medicinal products for human use, the GDP guidelines apply to your organization. A pharmaceutical wholesale distributor must have a Wholesale Distribution Authorization (WDA) to be able to distribute medicines (procure, store, and sell). To apply for a wholesale distribution authorization, you must comply with GDP regulations.

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