Pharmaceutical Technology-09-02-2015

Pharmaceutical Technology

Cleaning a Vial Filling Line

September 02, 2015

Troubleshooting

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Operator attention to detail and adherence to procedures are crucial for proper cleaning.

A Matter of Taste

September 02, 2015

Formulation

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Matt Shaffer, manager, formulation development, Bend Research, a division of Capsugel’s Dosage Form Solutions business, and Martin Koeberle, PhD, head of analytical development and stability testing, Hermes Pharma, spoke to Pharmaceutical Technology about the different approaches used in taste-masking and the challenges involved.

Manufacturers Face Key Policy and Regulatory Challenges

September 02, 2015

Regulatory Watch

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Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

Computerized Systems Validation

September 02, 2015

Ask the Expert

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Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

Collaborating on GMP Inspections

September 02, 2015

Regulatory Watch

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EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.

Industry Expert Q&A with Robin M. Silva

September 02, 2015

Industry Leaders

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Industry Expert Q&A with Robin M. Silva, Partner, Morgan, Lewis, and Bockius LLP

The Metrics of Quality Culture

September 02, 2015

Industry Insider

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FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

Pharmaceutical Technology, September 2015 Issue (PDF)

September 02, 2015

Issue PDF

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Click the title above to open the Pharmaceutical Technology September 2015 issue in an interactive PDF format.