Streamlining Raw Materials Testing

The rapid testing of biologic raw materials can lead to greater efficiency.
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Electronic Batch Records Offer Advantages beyond Automation

Transitioning from paper records to electronic batch records decreases costs and increases efficiency.
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SUPPLY CHAIN

Planning for the Future of Serialization

Compliance with the new traceability requirements necessitates an understanding of how and when to begin implementing changes in an ever-evolving industry.
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PEER-REVIEWED RESEARCH

Evaluating Disinfectant Efficacy of a Silver-Based Disinfectant

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.
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DRUG DEVELOPMENT

EMA and HMA Reveal Network Strategy for Next Five Years

This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.
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API SYNTHESIS & MANUFACTURING

Considering Continuous Crystallization

An integrated pilot plant tests heteronucleation and continuous crystallization.
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TROUBLESHOOTING

Fixing Tableting Problems

Tablet press adjustments can prevent manufacturing and product quality problems.
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OUTSOURCING REVIEW

Biomanufacturing Outsourcing Globalization Continues

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.
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REGULATORY WATCH

ICH Prepares for Major Reform

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.
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OTHER FEATURES

Ensuring the Quality of Biologicals

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
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How to Stay Abreast of Shifting Regulations and Remain Compliant

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.
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Webcasts

Stability Assessment for Shipment of API and Drug Products

Thursday, May 21, 2015, 11 am EDT
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Sponsored by: Patheon

The Importance of Data Integrity in a GXP Regulated Laboratory

Wednesday, May 27, 2015 at 11AM ET
With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by: Mettler Toledo

Building the Future: Using Simulation Effectively

Thursday, June 3, 2015, 11 am EDT
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Sponsored by: Baxter