GMP:KnowHow
Pharma Logistics (GDP)
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Content
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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Your Options
Advantages of Using the GMP:KnowHow Pharmalogistics (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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