Sourcing and Management by Pharmaceutical Technology
October 2014 Volume 10 Issue 10

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In this issue: News, interviews, and articles on shifts in outsourcing relationships, using The Cloud to enhance communication with suppliers, API and excipient development challenges, and business news.

Outsourcing
Pharma Outsourcing Driving Need for Cloud-Based Services
By Cynthia Challener, PhD
Multidirectional collaboration is critical for the new pharma business model; cloud-based information services can offer a communications alternative.
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Geographic Proximity Not a Factor in CMO Selection
By Eric Langer
Annual outsourcing study identifies the markets best poised to profit from the internationalization of outsourcing.
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API Synthesis & Manufacturing
New Techniques Advance Asymmetric Synthesis
By Cynthia Challener, PhD
A literature survey underscores the breadth of chiral chemocatalysis and interesting new techniques for the selective preparation of asymmetric compounds.
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QbD Facilitates Robust API Development
By Cynthia Challener, PhD
With a quality-by-design approach, robust processes can help deliver quality product consistently.
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API Developers Pass Inspections and Upgrade Capabilities
By Rita Peters
Added manufacturing capabilities, partnerships, and regulatory milestones mark recent achievements by API developers.
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Quality and Regulations
Guest Viewpoint: A Case for an FDA Dean's List
By Guy Villax
Quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.
>> Read More

Excipient Variability: Causes, Identification, Control
By Adeline Siew, PhD and Rita Peters
Industry experts examine reasons why the quality and composition of excipients can vary including environmental factors, processing methods, raw material quality, manufacturing location changes, and operator actions.
>> Read More

Contract Services Roundup
Catalent and Cingulate Therapeutics to Collaborate on New ADHD Formulation

Almac Group Appoints Two Marketing Directors

PCI Acquires Biotec

Molecular Profiles Expands Capsule Capability

DPT Laboratories Acquires Media Pharmaceuticals' Lakewood Facilities

Travtec Expands Operations in Lancashire

Industry News
Natoli Engineering Opens Natoli Institute for Industrial Pharmacy Research and Development

UPS' Pain in the Supply Chain Results

Webcasts
Risk-Assessment Strategy for Validating Environmental Monitoring Software
Thursday, October 2, 2014 at 1PM EDT
Sponsored by Vaisala

Worry-free weighing: Dealing with static and drafts
Thursday, Oct. 9, 2014, 11:00 am EDT
Sponsored by Mettler Toledo

Preparing for the New Elemental Impurities Guidelines
Tuesday, Oct. 14 at 11:00 am EDT | EU: Tuesday, Oct. 21 at 15:00 CEST
Sponsored by SGS Life Science Services

Systematic and Efficient Analytical Method Development for A Speedy Clinical Product Development
Wednesday, October 15, 8:00 am PDT/ 10:00 am CDT/ 11:00 am EDT
Sponsored by Patheon