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GMP:KnowHow
Pharma Logistics (GDP)

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The online knowledge portal GMP:KnowHow Pharma Logistics (GDP) offers comprehensive logistics knowledge for all parties involved in the supply chain of medicinal products and medical devices. It describes the practical implementation of the EU GDP Guidelines and other relevant regulations. In addition, editable sample documents, such as SOPs and various quality documents, are available.

Practical knowledge and the respective regulations:

The heart of this knowledge portal is the section Correct implementation of the EU GDP Guidelines. It is structured analogously to the EU GDP Guidelines (2013/C 343/01), as they represent the leading guidelines in the GDP context.

The special feature of this part – it provides two categories for each topic:

  • On the Practical knowledge pages, the individual chapters are interpreted.
  • On the Regulations pages, you will find the most important regulatory citations assigned to the relevant GDP chapter. Not only the EU GDP Guidelines have been taken into account, but many other relevant regulations.

GDP in Practice

The supply chain for medicinal products and medical devices is international in scope and involves many participants. Understanding of GDP varies greatly depending on the country and industry. Various guidelines and laws must be taken into account, as well as the interfaces with GMP.

To ensure patient safety, the supply chain for medicinal products and medical devices is subject to strict regulation and monitoring. In Europe, the EU GDP Guidelines are the leading document.

Here you will find expert knowledge from practice, requirements from the perspective of the authorities, application examples and sample documents.

  • Quality Management
  • Personnel
  • Premises and Equipment
  • Documentation
  • Operations
  • Complaints and Returns
  • Outsources Activities
  • Self-Inspections
  • Transportation

GMP Regulations

This part includes all relevant national and international GxP regulations. The regulations are kept up-to-date.

  • EU GDP Guidelines (2013/C 343/01 and 2015/C 95/01)
  • EU GMP Guide Part I – III and Annexes
  • AMG, AM-HandelsV, AMWHV
  • MPDG, HMG, AMBV
  • PIC/S (PE 011-1, PI 047-1 Annex)
  • WHO (GSDP & GTDP)
  • DIN EN ISO 9001:2015, 13485:2016

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GMP:KnowHow Pharma Logistics (GDP) | Named User License | 3M

GMP:KnowHow Pharma Logistics (GDP) | Named User License | 3M

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)
€460.00 net excl. VAT
GMP:KnowHow Pharma Logistics (GDP) | Named User License | 12M

GMP:KnowHow Pharma Logistics (GDP) | Named User License | 12M

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)
€610.00 net excl. VAT
GMP:KnowHow Pharma Logistics (GDP) | Business Package | 12M

GMP:KnowHow Pharma Logistics (GDP) | Business Package | 12M

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)
€1,830.00 net excl. VAT

Advantages of using the GMP:KnowHow Pharmalogistik (GDP)

  • You save valuable time! Editable templates for SOPs, sample contracts and much more make document creation easier.
  • You are always on the safe side! In addition to recommendations for action, you have all the important legal passages at your fingertips.
  • You save on consulting costs! No matter how often and for how long you need the portal: it is always there for you.
  • Including Annex 21 and interpretation for practical use.
  • You are always up-to-date! Updates and addition of new content is included for you.
  • Comfortable full-text search
  • Wiki structure and clickable graphics make navigation easy.
  • Button for questions to the editors: Send us your questions directly via email
  • Information about new content via the "INSIDER" email
  • Easy access via standard browser

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GMP:KnowHow Pharma Logistics (GDP)

GMP:KnowHow Pharma Logistics (GDP)

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)
€460.00 net excl. VAT
GMP:KnowHow Pharma Logistics (GDP) | Free Demo Access

GMP:KnowHow Pharma Logistics (GDP) | Free Demo Access

Your perfect tool for GDP-compliant storage and transportation The demo access is free and absolutely non-binding. It ends automatically after 7 days. How the GMP:KnowHow Pharma Logistics (GDP) supports you: Practical Knowledge Here, the respective GDP chapter is summarized and interpreted in simple terms. In particular, the practical implementation at a logistics service provider is considered in the interpretation. You also receive many editable sample documents. By the way – you can always ask our experts: Ask your specific questions directly form the online portal. Receive personal answers. Regulations All relevant GDP regulations are covered and are always up-to-date. You will find all relevant passages from the various pieces of legislation that have been assigned to the respective GDP chapter. This gives you a direct overview of the underlying regulatory requirements for each topic.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)
€0.00 net excl. VAT