FILTER INTEGRITY TESTING

Failure Mode Effects Analysis for Filter Integrity Testing

Understanding 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

The 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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Visible 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

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

Europe Moves Forward on Anticounterfeiting Measures

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

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

Conjugation Chemistry with Highly Potent Compounds

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.
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PACKAGING FORUM

Blister Pack Optimization

Science-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

A 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

Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.
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Webcasts

Best Practices for Effective Product Transfer

On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma

Calibration and Qualification of Laboratory Instruments in Accordance with GMP Requirements

On Demand
Calibration, qualification, and the right appropriate level of routine testing for laboratory instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. Understand the relationship between these factors to optimize testing and be prepared for audit.
Sponsored by Mettler Toledo