Pharmaceutical Technology-10-02-2016

Pharmaceutical Technology

Protecting Parenterals in Primary Packaging

October 02, 2016

Packaging Forum

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10

Primary packaging and manufacturing technologies minimize product/package interaction, protect quality, support safe travel through the supply chain, and enhance performance at point of use.

Manufacturers Face Major Changes under PDUFA VI

October 02, 2016

Regulatory Watch

40

10

Efforts to accelerate drug development will alter fee structure and require ready production sites.

Defining Risk Assessment of Aseptic Processes

October 02, 2016

Ask the Expert

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Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

Calling All Authors

October 02, 2016

From The Editor

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The editors seek drug development experts to contribute technical articles for 2017.

Tracking a Global Problem

October 02, 2016

Features

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10

A number of organizations have analyzed and estimated the size of pharma’s counterfeit and diversion problem.

Pharmacovigilance of Biologics Under Scrutiny

October 02, 2016

Regulatory Watch

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10

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

Double Planetary Mixers for Heavy Duty Mixing

October 02, 2016

Product Spotlight

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The Double Planetary Mixers from Ross, Charles & Son are offered in 4-, 5-, 10-, and 25-gallon models for pilot-scale production of highly-filled pastes, dough-like materials, shear-sensitive gels, granulations, and powder blends.

Pharmaceutical Technology, October 2016 Issue (PDF)

October 02, 2016

Issue PDF

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

Protein Impurities Pose Challenges

August 01, 2016

Features

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Multiple methods are required for detecting and removing protein impurities.