Pharmaceutical Technology-11-02-2015

Pharmaceutical Technology

FDA Overhauls Inspection Operations

November 02, 2015

Regulatory Watch

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New program emphasizes quality, risk, and global collaboration.

Good Documentation Practice: Saving Data for the Long Term

November 02, 2015

Ask the Expert

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Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

Identifying Causes Of Delamination

November 02, 2015

Peer-Reviewed Research

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Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.

Advances in Heterocyclic Chemistry for API Synthesis

November 02, 2015

API Synthesis and Manufacturing

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Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C–H silylation reactions

EU’s New Telematics Strategy for the Regulation of Medicines

November 02, 2015

Regulatory Watch

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The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.

Single-Use Shipping Solutions

November 02, 2015

Product Spotlight

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Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids.

Packaging Inspection Machines

November 02, 2015

Product Spotlight

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Pharmaceutical inspection machines from Bosch Packaging Technology include the KHS 1, which uses laser headspace analysis (HSA), and the AIM 3, which uses high-voltage leak detection (HVLD), for container closure integrity testing.

Industry Suppliers Honored for Innovative Advances

November 02, 2015

From The Editor

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The CPhI Pharma Awards celebrate innovations in the pharma industry.

Addressing Parenteral Manufacturing Challenges

November 02, 2015

Cover Story

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Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

Pharmaceutical Technology, November 2015 Issue (PDF)

November 02, 2015

Issue PDF

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