Articles by DPT Laboratories - Pharmaceutical Technology

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Articles by DPT Laboratories

DPT Laboratories

What is Quality by Design (QbD) – and Why Should You Care?
February 26, 2014

Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone.

Managing the Complexities of Global Pharmaceutical Sourcing
June 26, 2013

With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for raw materials, intermediates, active pharmaceutical ingredients (APIs), and other material components for clinical supplies and commercial manufacturing. Download this white paper to learn more.

Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider
April 25, 2013

In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA?s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices (cGMP) are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. While both sponsor companies and service providers must adhere to robust quality standards and undergo regular regulatory inspections, manufacturers are ultimately held responsible by regulatory agencies when it comes to adhering to cGMPs.


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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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