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FDAnews Management Report: Managing Contract Manufacturers and Testing Labs

Falls Church, VA (PRWEB) November 18, 2013

Managing Contract Manufacturers and Testing Labs
**FDAnews Management Report**

When a contract manufacturer or testing lab notices something unusual about a company’s product — an unusual result, a change in raw materials supplier, a new piece of equipment or packaging — do they react the way the company wants?

  •     Do they know the batch release requirements?
  •     Do their certificates of analysis satisfy the company’s needs?
  •     Have they changed software?
  •     Do they know the storage parameters for the 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.

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This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It will walk readers through an exhaustive, 45-topic analysis of managing contractors. Plus it’s loaded with tools and samples that will make 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 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 readers can put to use today, including:

  •     Model Contract Frameworks
  •     Model SOPs
  •     Sample Audit Checklists
  •     And more

Plus a troubleshooting guide to the most common mistakes made in contracting services.

Time for Action …
If the company just starting to outsource, or already managing contracted services, this report will help make sure contracted manufacturers and testing facilities are operating in compliance with the FDA and EU GMP principles, and most of all, the company’s own high standards.

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Managing Contract Manufacturers and Testing Labs
**FDAnews Management Report**

FORMAT: Print or PDF
PRICE: $377

By phone: 888-838-5578 or 703-538-7600

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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