GMP:KnowHow Pharma Logistics (GDP) | Named User Licence | 12M
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GDP-compliant storage and transportation – the easy way.
Always on the safe side with access to logistics knowledge for practitioners in the pharmaceutical industry.
The wiki structure and clickable graphics make navigation easy.
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netto zzgl. MwSt.Bitte beachten: Mit dem Kauf dieses Artikels bestätigen Sie, dass Sie die allgemeinen Lizenzbedingungen gelesen und akzeptiert haben.
Produktinformationen
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.
Author
Simone 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.
| Available Subscription Plans: | Named User Licence (3-month-subscription), Named User Licence (12-month-subscription), Business Package with 5 Named User Licences (12-month-subscription) |
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With the GMP:KnowHow Pharma Logistics (GDP)
- you have access to all relevant information 24/7.
- you are always up to date thanks to continuous updating.
- you can download practical and editable templates. (SOPs, job descriptions, quality assurance agreement (QAA), ...)
- you save a lot of time searching for the applicable regulations. you understand even complex content using practical examples and infographics.
What you need to use our portals: Technical requirements
Contents of the GMP:KnowHow Pharma Logistics (GDP)
- In the “Practical knowledge” tab, 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.
- In the “Regulations” tab, 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.
- Quality Agreement for GMP/GDP-compliant Logistics Services
- Quality Manual
- SOPs
- Job Descriptions
- GDP Questionnaire
- Site Master File with Organisational Chart
- Best practice – the Peither Logistik GmbH
Updates
The GMP:KnowHow Pharma Logistics (GDP) is updated on an ongoing basis, both with renewed and additional content.
Updates are included in the price.
Infoletter Service: You won’t miss any important changes, because you will be automatically informed about the updates with our e-mail service Insider.
Target Group
Anyone involved in storage and transportation of pharmaceuticals, in particular employees in
- Logistics companies
- Logistics and quality departments in pharmaceutical companies
- Wholesalers
GMP:KnowHow Pharma Logistics (GDP) focuses on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients.
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