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A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.
2nd edition 11/2016
Delivery immediately after receipt of payment
Excerpt from the GMP Compliance Adviser
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:
And when it comes time to transfer technology, processes, information or product to your contractor, the report will teach you:
Outsourcing laboratory testing and analysis can be especially challenging, but with this report, you’ll know how to:
In addition to step-by-step guidance, this report includes tools you can put to use today, including:
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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.
This file is in PDF format!Filesize: 2,3 MB
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For auditors and manufacturers of drugs and APIs.
More than 650 typical questions...
SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"Standard draft to adapt...
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