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Managing Contract Manufacturers and Testing Labs

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September 2012
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When a contract manufacturer or testing lab notices something unusual about your product – an unusual result, a change in raw materials supplier, a new piece of equipment or packaging – do they react the way you want?

  • 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 you through 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

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

Time for Action …
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…

Cornelia Wawretschek
Pharmaceutical Quality Consultant whose work with the pharmaceutical industry dates back to 1979. Her experience includes work with Dr. Mann Pharma Berlin and Schering AG Berlin where she was responsible for GMP optimization, SOP systems, manufacturing documentation, preparation and execution of audits and inspections by authorities, training programs, qualification and validation.

Dr. Michael Hiob
Head of the medicinal products, pharmacies and narcotics section and in charge of the supervision of the GMP-inspection services at the German Ministry for Health of Land Schleswig-Holstein. He is an expert in numerous committees, e.g. of EMEA and ICH. He is a member of the expert group on "Qualification/Validation" (1998-2008 head of the group) and associate lecturer at the University of Kiel.

Max Lazar
Following a 40-year career in the pharmaceutical industry, Max Lazar established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance.

Frank Boettcher
Head of quality management at Labor L+S AG. Consultant and author on quality assurance and pharmaceutical analysis topics. His career has included positions as the head of laboratories for Solvay Pharmaceuticals GmbH, and head of quality control for Wülfing Pharma GmbH.

Thomas Peither
A GMP consultant for 18 years and an expert in the European GMPs. He co-founded the GMP publishing company Maas & Peither (Germany, USA) and the midsize pharma consulting company Halfmann Goetsch Peither (Switzerland, Germany, Singapore), which advises numerous pharmaceutical companies.

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