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

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Your knowledge portal for GDP-compliant pharmaceutical logistics. 

It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, comply with regulatory requirements. The GMP:KnowHow knowledge portal guides you through the complex regulatory landscape of the pharmaceutical and logistical supply chain!

The knowledge portal gives you an easy-to-understand overview of all the important topics. Interactive graphics help you navigate all 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 valuable research time.

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?

GMP:KnowHow Pharma Logistics (GDP) is a practical knowledge portal dedicated to Good Distribution Practice (GDP). 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, currently Director Quality at Fisher Clinical Services, previously served as Head of Quality Control and Responsible Person (GDP) for the 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)

With the GMP:KnowHow Pharma Logistics (GDP), you 

  • have access to all relevant information 24/7. 
  • are always up to date thanks to continuous updating. 
  • download practical, editable templates, including SOPs, job descriptions, Quality Agreements (QAs), and more.
  • save a lot of time searching for applicable regulations. 
  • understand even complex topics through 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” section, each GDP chapter is explained and interpreted in a clear and practical way.
  • 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 provides a direct overview of the regulatory requirements relevant to each topic.
  • Quality Agreement for GMP/GDP-compliant Logistics Services 
  • Quality Manual 
  • Standard Operating Procedures (SOPs)
  • Job Descriptions 
  • GDP Questionnaire 
  • Site Master File including Organisational Chart 
  • Best practice – the Peither Logistik GmbH

Updates

GMP:KnowHow Pharma Logistics (GDP) is continuously updated to ensure access to the latest information and practical guidance.

All updates are included for the duration of the subscription.

Newsletter Service: You will automatically receive email notifications about important updates and changes through our GMP Insider newsletter.

Target Group

Professionals involved in the storage and transportation of pharmaceutical products:

  • Logistics companies
  • Logistics and quality departments in pharmaceutical companies
  • Wholesalers

GMP:KnowHow Pharma Logistics (GDP) focuses on content that is essential for pharmaceutical logistics service providers and their clients involved in the handling of medicinal products, active pharmaceutical ingredients (APIs), and medical devices.

Do You Have Questions?

Yannic Matt, Kundenbetreuung und IT-Support beim GMP-Verlag

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

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

You will receive your login credentials via email. Throughout the week, you will receive further information about the GMP:KnowHow Pharma Logistics (GDP) directly in your inbox. Customer support is available to assist you at any time. You can also direct questions about the content to the editorial team and receive personalized responses. You do not need to cancel your demo access. The free access will end automatically. Advantages at a glance

delivery time appr. 2-5 workdays after receipt of payment
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GMP Compliance Adviser | Corporate Licence | 12M

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The GMP Compliance Adviser is an online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.In the GMP Compliance Adviser you’ll find: GMP in Practice This part contains 21 chapters with GMP expert knowledge to base your decisions upon. It provides practical assistance with checklists, templates and SOP examples. It is written by more than 80 authors with hands-on experience directly linked to the industry. The individual chapters describe the different aspects of GMP in clear language. Technical, organizational and procedural aspects are covered.More than 700 checklists, templates and examples of standard operation procedures taken directly out of practice help you in understanding the GMP requirements.GMP RegulationsThese chapters cover the most important GMP regulations from Europe and the United States (CFR and FDA), but also PIC/S, ICH, WHO and many more.  Sample Documents In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use.

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