Tuesday, May 13, 2008
Articles (46) White Papers (13) News (88) Products (11)

Contract Services Resource Center

Quality Agreements: Making Them Stick
PharmaManufacturing.com
A good working relationship is critical to the success of any vendor quality agreement, but the right approach to drafting these contracts can make them far more effective.

Facility of the Year Winner: IDT Biologika GmbH
PharmaManufacturing.com
Managing Digital Editor, Michele Vaccarello, speaks with Facility of the Year Award winner IDT Biologika GmbH at the 2008 Interphex Show in Philadelphia. Dr. Ralf Pfirmann, Managing Director of IDT, discusses operational excellence in their contract manufacturing facility for the production of live human viral vaccines.

Focusing on Phase 0
PharmaManufacturing.com
Materials characterization and the principles of manufacturability are guiding a Florida-based contract research and manufacturing company.

From the Editor: Curing Pharma’s China Syndrome
PharmaManufacturing.com
Accountability - on the part of finished drug manufacturers as well as their API suppliers - will prevent future quality and P.R. disasters

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White Papers: In depth research


Title Author Date
Risk Management in Next Generation Outsourcing Hunton & Williams and Marsh 03/11/2008
In the white paper, law firm Hunton & Williams and leading insurance broker Marsh examine how new outsourcing models have resulted in new areas of risk and a more complex contractual and commercial structure being required. 
Virus Testing For Biological Products: Partnering With a Contract Lab Microtest Laboratories 11/01/2007
This paper by Microtest Laboratories is an introduction to the virus testing that is required for biological products. When working with a contract testing supplier, each product must be evaluated individually and given the customized treatment it needs. The contract testing supplier should be a partner in the process to ensure that the virus safety requirements are met, and the testing strategy is tailored for each company and product. 
A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials The Institute of Quality Assurance 07/16/2007
This comprehensive guide written by The Institute of Quality Assurance is aimed at increasing the awareness of the quality management system requirements embodied in PS 9000. It adopts a risk assessment approach to the identification and implementation of preventive action and uses case studies to illustrate areas of GMP risk. 
Case Study: Robotics in an Oral Solid Dose Facility Industrial Equipment & Design Company 06/06/2007
An International Pharmaceutical Manufacturer had an Oral Solid Dosage processing facility with a problem: They were manually loading and unloading tablets to and from dryer trays, as well as handling the unwieldy trays themselves in and out of an oven dryer. In search of a solution, they approached IEDCO (Industrial Equipment & Design Company) for help. IEDCO was able to create a system using a column lift, support structure, tabley surge hopper, and discharge hopper to solve the problem.  
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News

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