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Managing Contract Manufacturers and Testing Labs
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US$
397.00
pdf download
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.

NEW ++ NEW ++ NEW
Edition: 2nd edition, 11/2016
138 Pages
ISBN: 978-3-95807-057-8
Delivery: immediately after receipt of payment
Excerpt from the GMP MANUAL

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.

Reading Sample

Managing Contract Manufacturers - Reading Sample

Technical Requirements

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Filesize: 2,3 MB

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
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.
Gausepohl, Dr. Christian

Gausepohl is Head of the Quality Unit and a Qualified Person at Rottendorf Pharma. He has worked in many different positions and has extensive experience of carrying out audits and inspections for authorities, customers and suppliers. His main concern is the practical implementation of GMP requirements.



Böttcher, Dr. Frank

Frank Böttcher is a pharmacist who has specialised in pharmaceutical analysis. He has worked in the pharmaceutical industry for many years and has held positions in different companies. He became CEO of Labor L+S AG in 2015 and is responsible for Operations, Quality, HR and Finance. Frank Böttcher is an authorised expert in accordance with the German Drugs Act (AMG § 65.4) and is involved in a number of different working groups that focus on the testing of medicinal products and medical devices. His other areas of expertise include contract agreements in the area of contract manufacture and testing as well as the manufacture and testing of sterile products.

Recommendations
GMP-Questionnaire: Contract manufacturing / Contract analysis
GMP Fundamentals – A Step-by-Step Guide (download)
GMP MANUAL Single User Licence (yearly subscription)