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.

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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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