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FILTER INTEGRITY TESTING

Failure Mode Effects Analysis for Filter Integrity Testing

Magnus SteringUnderstanding of the risks associated with FMEA is crucial in lot release testing.
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PEER-REVIEWED RESEARCH

Concept Design for Establishing an Eco-Friendly Pharmaceutical Production Facility in Malta

Maria Mercieca, Frederick Schembri, Anthony Serracino Inglott, Lilian M. AzzopardiThe authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
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Ruggedness of Visible Residue Limits for Cleaning Validation

Richard J. ForsythVisible residue limits have been shown to be a valuable tool in validated cleaning validation program.
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OUTSOURCING REVIEW

CMC Development is Hot

Jim MillerDemand is driving expansion and consolidation of formulation and clinical trial materials services.
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REGULATORY WATCH

Europe Moves Forward on Anticounterfeiting Measures

Sean MilmoThe European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.
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Vaccine Development Faces Urgency and Challenges

Jill WechslerGlobal outbreaks energize vaccine R&D and drive production modernization.
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API SYNTHESIS AND MANUFACTURING

Conjugation Chemistry with Highly Potent Compounds

Cynthia A. ChallenerManufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.
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PACKAGING FORUM

Blister Pack Optimization

Hallie ForcinioScience-based software and testing services expedite the material selection process and ensure blister packs deliver adequate barrier protection for solid-dosage forms without over-packaging.
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TROUBLESHOOTING

Understanding Measurement Uncertainty in Weighing: Balance Calibration

Ian Ciesniewski, Joanne Ratcliff, PhDA program for calibration and routine testing of weighing instruments ensures accurate results.
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EDITOR’S COMMENT

The Repercussions of Data Integrity Violations

Adeline Siew, PhDPharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.
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