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Keys to Contract Manufacturing: Flexibility and Localization
PharmaManufacturing.com
Jim Kernan, Joint Managing Director of Nenagh Ireland's PharmaFlow, addresses the importance of flexibility and localization of small-to-midsize batch contract manufacturing and discusses why companies should look to Ireland as a port of entry to Europe.
AstraZeneca’s David Brennan: Think Globally, Outsource Locally
PharmaManufacturing.com
While AstraZeneca has committed to outsourcing extensively, and to establishing prominence in China and other Asian countries, it does not have a “one-size-fits-all” approach to outsourcing, says CEO David Brennan in this exclusive interview. In many parts of the world, the company is still learning by doing and developing local strategies for when and how to outsource manufacturing and other operations, and when (as in China) to keep things mostly in-house.
Video: AZ’s Brennan on Manufacturing as a Core Competency
PharmaManufacturing.com
AstraZeneca raised some eyebrows a few years ago when executives suggested that the company would outsource most of its manufacturing operations. In this interview, CEO David Brennan clarifies this perception: It’s all about recognizing your core competencies, he says, and for AZ that means biologics and late-stage small molecule production. For “commodity” operations, outsourcing makes perfect sense, he says.
To Outsource or Not—Is Your Culture Ready?
PharmaManufacturing.com
When deciding whether or not to outsource, manufacturers must strip decision factors down to a basic few: Is there a business case to justify the risk? Will the outsourcing free you up to focus more on your core competencies? And finally, is your culture ready for outsourcing? This video is the start of a series with outsourcing expert Rakesh Kishan, CEO of UMS Advisory, Inc., about the need for pharmaceutical manufacturers to see outsourcing in a new light—as an opportunity to focus operations and empower employees.
White Papers: In Depth Research
Risk Management in Next Generation Outsourcing
Author: Hunton & Williams and Marsh
Posted: 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
Author: Microtest Laboratories
Posted: 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
Author: The Institute of Quality Assurance
Posted: 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
Author: Industrial Equipment & Design Company
Posted: 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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