-
« Übersicht |
- GMP-Verlag Peither AG
- GMP-Shop
- GMP-Publikationen
- Englisches GMP-Fachwissen
Managing Contract Manufacturers and Testing Labs
Geben Sie die erste Bewertung für diesen Artikel ab
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.
e-book
138 Seiten
ISBN: 978-3-95807-057-8
2nd edition 11/2016
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"
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.
Technical Requirements
This file is in PDF format!
Filesize: 2,3 MB
To view PDF files, we recommend using the Adobe Reader.
https://get.adobe.com/de/reader/
The e-book is password protected to prevent copying and modification of content.
Please note the following procedure guidelines:
For payment by invoice:
- You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
- After receipt of payment you will receive an e-mail with the download information.
When paying by credit card:
- Immediately after the credit card payment you will receive an email with the download information.
- Your invoice will be sent in a separate e-mail within 1-2 working days.
87,00 € netto
93.09 - 7.00
249,00 € netto
266.43 - 7.00
75,00 € netto
80.25 - 7.00
495,00 € netto
529.65 - 7.00
LOGFILE
Der Newsletter des GMP-Verlags
News und aktuelle Trends: Mit dem LOGFILE sind Sie immer up-to-date!
> Jetzt kostenlos abonnieren!Ihre Währung
Bitte wählen Sie Ihre Währung aus