Pharmaceutical Technology-03-02-2016

Pharmaceutical Technology

Generic-Drug Production and Oversight Challenge FDA and Manufacturers

March 02, 2016

Regulatory Watch

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Policy makers debate strategies for promoting access to less costly medicines.

Phase-Appropriate GMP

March 02, 2016

Ask the Expert

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Siegfried Schmitt, principal consultant, PAREXEL, discusses how the regulatory requirements for CGMPs is the different phases of drug development and manufacture.

FDA GDUFA Testimony Presentation Slides

March 02, 2016

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Slides from the FDA GDUFA presentation before the Senate Health, Education, Labor and Pensions Committee in January 2016.

Keynote Series Addresses Crucial Industry Issues

March 02, 2016

From The Editor

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Thought leaders tackle drug shortages and manufacturing innovations.

Multimode Microplate Reader Improves Sensitivity

March 02, 2016

Product Spotlight

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The Spark 20M multimode microplate reader has the ability to read 6- to 1536-well microplates and includes a high-frequency xenon flash lamp that can be combined with detection modules.

Pharma Outsourcing Market Expands

March 02, 2016

Outsourcing Outlook

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The pharma outsourcing market starts 2016 with expansions, acquisitions, and new offerings.

Tackling Regulatory Challenges of EU’s Variations Framework

March 02, 2016

Regulatory Watch

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The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.

Statistical Tools to Aid in the Assessment of Critical Process Parameters

March 02, 2016

Peer Reviewed

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There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).

Concerns Mount Over Data Integrity and Compliance Issues Abroad

March 02, 2016

Cover Story

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Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

Pharmaceutical Technology, March 2016 Issue (PDF)

March 02, 2016

Issue PDF

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Click the title above to open the Pharmaceutical Technology March 2016 issue in an interactive PDF format.