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Managing Contract Manufacturers and Testing Labs

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A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.


138 Seiten

ISBN: 978-3-95807-057-8

2nd edition 11/2016

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345,00 € netto


Excerpt from the GMP Compliance Adviser

  • Are your contract manufacturers getting you in trouble?

Problems with a contract manufacturer or lab can emerge in dozens of unexpected places. From changes in personnel or equipment to faulty SOPs and training, the list can seem impossible to tame.

This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It covers all aspects of selecting and managing contractors, including:

  • Scope of the contract
  • Responsibilities of both parties
  • Selecting a project team
  • Creating a project plan
  • Change control
  • Procurement
  • Sampling
  • Stability testing
  • Transportation
  • Documentation
  • Communication

And when it comes time to transfer technology, processes, information or product to your contractor, the report will teach you:

  • What kind of documentation do you need for effective transfer
  • How to identify risk in the transfer process
  • How to handle transport validation

Outsourcing laboratory testing and analysis can be especially challenging, but with this report, you’ll know how to:

  • Decide what testing should and should not be outsourced
  • Select a testing laboratory
  • Audit and monitor the laboratory
  • Design effective testing contracts
  • Transfer tests, analytical procedures, microbiological methods and more
  • Handle certificates of analysis

In addition to step-by-step guidance, this report includes tools you can put to use today, including:

  • Quality agreement outline
  • Contractor questionnaire
  • Contractor evaluation checklist
  • Certificate of analysis outline
  • List of transfer documentation
  • Project team function matrix
  • Product transfer plan outline
  • Sample transfer plan.

Weitere Informationen

Reading Sample "Managing Contract Manufacturers and Testing Labs"

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If you’re just starting to outsource, or already managing contracted services, this report will help you make sure your contracted manufacturers and testing facilities are operating in compliance with the FDA and EU GMP principles, and most of all, your own high standards.

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