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.
Reading SampleManaging Contract Manufacturers - Reading Sample
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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.