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18 June 2013

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Top Stories

The EU Changes Guidelines for Good Distribution Practices An expert discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use. More...

Model-Predictive Design, Control, and Optimization Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process. More...

Methods for Identifying Out-of-Trend Results in Ongoing Stability Data The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies. More...

Risk-Mitigation in Drug Manufacturing for Emerging Markets Emerging markets are a crucial part of pharmaceutical companies’ growth strategies, but in serving those markets, pharmaceutical and biopharmaceutical manufacturers must align that strategy with partners that can facilitate access to local markets, manage complex supply chains, meet global and national regulatory standards for quality, and secure production for local as well as established markets in North America and Western Europe. More...

Quality Focus: Achieving Raw Material Transparency The increased globalization of the pharmaceutical and biopharmaceutical industries, resulting in more complex and elongated supply chains on a raw material and ingredients basis, obligates suppliers and pharmaceutical and biopharmaceutical companies to develop ways to achieve greater transparency and understanding of those supply chains to ensure product quality and regulatory compliance. More...

News

US Supreme Court: Human Genes Are Not Patentable The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented. More...

Lilly Terminates Phase II Study of Alzheimer’s Drug Eli Lilly has discontinued its Phase II study, which investigated the company’s beta secretase inhibitor, LY2886721, as a treatment for Alzheimer’s disease due to abnormal liver biochemical tests identified during routine monitoring. More...

ISPE Study Reports on Root Causes for Drug Shortages
ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages. More...

USP Forms Elemental Impurities Advisory Group USP appoints regulatory experts to elemental impurities implementation advisory group. More...

GlaxoSmithKline Acknowledges Misrepresentation in Scientific Article One employee is dismissed, another has resigned, and three others are put on administrative leave. More...

EMA Revises Biosimilars Guideline EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation. More...

Take Our Survey
Outsourcing Trends for the Pharmaceutical and Biopharmaceutical Industries The editors of Pharmaceutical Technology Europe seek your feedback on trends for contract services for manufacturing, research, and related support. If you are from a pharmaceutical/biopharmaceutical company or contract service provider, please complete this brief confidential editorial survey. More...

Webcasts
Achieving Raw-Material Transparency in the Pharmaceutical/ Biopharmaceutical Supply Chain (June 18) Sponsored by SAFC

Regulatory, Biosafety, and Clinical Considerations for Vaccine Development (June 18) Sponsored by SGS Life Science Services

Risk Mitigation for Alcohol-Dose Dumping in Controlled Release Forms (On Demand) Sponsored by FMC

Minimizing Out-of-Specification (OOS) Errors Using a Risk-based Gravimetric Approach (On Demand) Sponsored by Mettler Toledo

More Webcasts

Products/Services Profiles

Colder Products Company
AseptiQuik™ connectors provide easy and reliable sterile connections for single-use biopharmaceutical processing. Available from 1/8” (3.2mm) to 1” (26.4mm) to quickly transfer valuable media. See the videos from Colder Products Company.

Equipnet
Online auction of top quality equipment in June: EquipNet Auctions is conducting a major sale of Pharmaceutical Processing and Packaging Equipment. Read more

This week we would like to know...

What is the single greatest threat to maintaining manufacturing processes at your facility?

Reference Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products ... Click here

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