Managing Contract Manufacturers and Testing Labs: 2016 Edition
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;
- Stability testing;
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.
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.
About the Authors
Christian Gausepohl, PhD, is head of quality assurance and a Qualified Person at Rottendorf Pharma GmbH. His expertise includes coordinating technology transfers, process optimization and validation plans and conducting audits for regulatory authorities, drugmakers and suppliers.
Frank Boettcher, PhD, is CEO of Labor L+S AG and a consultant and author on quality assurance and pharmaceutical analysis topics. He is an authorized expert in accordance with the German Drugs Act (AMG §65.4) and is involved in a number of working groups that focus on the testing of medicinal products and medical devices.
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Christian Gausepohl, PhD and Frank Boettcher, PhD
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