Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
|Articles|March 13, 2012
Gateway 2012: Brabender Pharma
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Brabender® Pharma USA, Inc.
50 East Wesley Street
South Hackensack, NJ 07606
Kevin Van Allen
201.220.6660
Be sure to visit us at AAPS 2012, booth # 4900
Brabender® Pharma USA, Inc. is an innovative company specializing in the manufacturing of twin-screw extruders for HME applications. The effort has been to concentrate on top quality equipment to produce small batch sizes up to production scale processes. The 12 mm Mini-Compounder is ideally suited to this undertaking while other models offer options to achieve production capacity. Our success is accomplished by many years of knowledge in this area – we present a solution to the increased demand for small batch analysis while providing the finest quality equipment and instruments. Brabender® Pharma is pleased to announce the opening of our new GMP Pharma Testing Laboratory located in Duisburg, Germany. With the introduction of this laboratory, we complement our customers’ needs for a GMP testing laboratory utilizing our 12 mm Mini-Compounder for HME – Hot Melt Extrusion.
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