- Do they know your batch release requirements?
- Do their certificates of analysis satisfy your needs?
- Have they changed software?
- Do they know the storage parameters for your products?
- Have they changed key personnel?
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. Until now.
This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It will walk you through an exhaustive, 45-topic analysis of managing contractors. Plus it’s loaded with tools and samples that will make your contract manufacturing headaches disappear.
Managing Contract Manufacturers and Testing Labs walks through the all the steps necessary for managing contract manufacturers, from selection of a company to auditing of ongoing operations, it addresses all the topics you’ll need to consider when contracting, including:
- Manufacture of development or pilot batches;
- Procurement of primary and secondary packaging materials;
- Procurement of raw materials, excipients and active pharmaceutical ingredients;
- Approval of the starting materials;
- Transfer of analytical methods;
- Manufacturing of validation batches;
- Determination of the manufacturing technology;
- Determination of the packaging technology;
- Determination of sampling during validation and routine manufacture;
- Physical and analytical testing scope;
- Release of intermediate products and final products; and
- Storage and delivery of the finished product
The section on managing analytical testing provides additional, practical advice for outsourcing and overseeing lab services, whether they are packaged with manufacturing services or separate. It covers:
- How to solicit and review external laboratories
- Preparing a request for specific services information, including:
- Preliminary audits and qualification
- Establishing lab-to-lab transfer modes
- Determination of analytical methodology
- Contracting basics
In addition to step-by-step guidance, this report includes tools you can put to use today, including:
- Model Contract Frameworks
- Model SOPs
- Sample Audit Checklists
- And more
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