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Creating a Master Plan for Drug Warehousing, Transportation and Distribution

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This e-book is the ultimate guide to preparing your company for compliance with GDP. Step by step, it walks you through the planning and implementation process, including the six key requirements included in the EU GDP Guidelines!

e-book

99 Seiten

ISBN: 978-3-943267-93-8

1st edition 2014

Lieferung sofort nach Zahlungseingang

345,00 € netto

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Excerpt from the GMP Compliance Adviser

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

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Bitte geben Sie die Zeichenfolge in das nachfolgende Textfeld ein.

Die mit einem * markierten Felder sind Pflichtfelder.

  • 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

Technical Requirements

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Filesize: 3,4 MB

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Please note the following procedure guidelines:

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  • You will receive an advance invoice.
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If you choose payment by credit card:

  • You will receive an email with the download information immediately after the credit card payment.
  • The invoice will be sent by postal mail as soon as possible.
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