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Creating a Master Plan for Drug Warehousing, Transportation and Distribution
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Creating a Master Plan for Drug Warehousing, Transportation and Distribution
€ 279.00
net
€ 332.01
  19% VAT included
PDF-Download
US$
397.00
Guide to preparing a company for compliance with Good Distribution Practice (GDP)

NEW ++ NEW ++ NEW
Edition: 1st edition 2014
99 Pages
ISBN: 978-3-943267-93-8
Excerpt from the GMP MANUAL

Did a truck driver just ruin a drug shipment?
Not only do you need to protect your drugs from tampering... you must shield your drugs from the extremes of heat and cold during transit... and store and dispense your products so they're as safe and effective as they were when they left the plant.

That means companies like yours need to begin NOW to create a master plan that establishes how your distribution chain will protect the integrity of your products, from the very beginning of your supply chain all the way to the customer’s doorstep.

This e-book is the ultimate guide to preparing your company for compliance with Good Distribution Practice (GDP).

Step by step, it walks you through the planning and implementation process, including the six key requirements included in the EU GDP Guidelines:
- Procurement, storage, delivery and export of medicinal products in conformity with GDP
- Definition of managerial competence and responsibility
- Shipment of medicinal products
- Prompt provision of documentation
- Documentation and follow-up on deviations
- Initiation of CAPA actions

With the EU rules already in place, enforcement will not be far behind. Now is the time to make sure your distribution master plan is in place and fully up to date. Order your copy of Creating a Master Plan for Drug Warehousing, Transportation and Distribution today.

What You Will Learn
- The challenges to be faced in validating a global transport chain
- The procedure for validating a cold chain
- Aspects to consider in shipping by refrigerated trucks
- What storage conditions apply for medicinal products requiring special conditions (frozen, refrigerated, ambient)
- The transport requirements found in pharmacopoeias and relevant guidelines
- The role risk management plays in transport
- The risks that can occur during transport
- How risks can be assessed and controlled
- What is meant by active and passive temperature control
- The requirements that air freight containers have to meet
- The advantages and disadvantages of temperature loggers
- Under what conditions RFID technology can be used
- The opportunities that modern telematics systems offer
- The features and tools an alarm system must have
- The steps needed to qualify large-scale, actively temperature-controlled systems
- Test conditions for operational and performance qualification
- The responsibilities of a logistics service provider

Table of Contents

About the Authors
Introduction
Regulatory Principles: EU, US, Canada and WHO
Transport Conditions: Transport as Mobile Storage
Transport Vehicles and Transport Packaging
Modes of Transportation: Guidelines and Quality Standards for Land Transportation
Monitoring Transport Temperatures
Risk Management in Transportation
Qualification of Large-Scale Active Systems (Trailers)
Logistics Service Providers
Transport Validation
References

Reading Sample

Creating a Master Plan for Drug Warehousing, Transportation and Distribution - Reading Sample

Please note the following procedure guidelines:

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Technical Requirements

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- Pharmaceutical plant managers
- Quality assurance managers
- GDP managers
- GMP managers
- Supply chain managers
- Cool chain and cold chain process managers
- Product safety managers
- Risk managers
- Transportation managers
- Regulatory affairs managers
- Packaging managers and repackagers
- Trucking managers
- Air freight managers
- Pharmacists
Christoph Frick is the head of pharmaceutical development at Kohlpharma in Germany. He has worked for years at Kohlpharma and other companies as the head of quality assurance, good manufacturing practice, good documentation practice, cool chain processes, risk management, qualification and validation, auditing, business development and regulatory affairs.

Nicola Spiggelkötter is a pharmaceutical consultant with years of experience in quality assurance and API sourcing, cold chain process optimization, audits, staff training and risk management.
Recommendations
GDP Audit Checklist(Book)
GMP Supplier Assessment Questionnaire
Quality Agreement