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Business & Regulation Facilities, Small Molecules, Standards & Regulation

Hygiene Conundrum

Many companies have been on the receiving end of FDA warning letters – and issues around cleaning arise time and time again. Failure to adequately clean equipment, failure to validate the cleaning verification method, failure to follow cleaning procedures... A quick reminder of the regulations: the cleanliness of non-dedicated equipment should be verified before subsequent release for use in the manufacture of intermediates and APIs, and at product change over to prevent cross-contamination. The cleaning procedure must be validated according to FDA requirements (1), and companies must employ cleaning steps that are reproducible and effective.

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About the Authors

Andrei Blasko

Andrei Blasko, Ph.D., FRSC, is a Senior Fellow at Novartis Pharmaceuticals Corp. working in Inhalation Technical Development. He is also member of the Editorial Board of the American Journal of Advanced Drug Delivery. Previously Dr. Blasko was Director of Analytical Method Development and co-lead a Drug Discovery & CMC Development program at Pain Therapeutics, Inc., where he managed projects in drug discovery, structural biology, and analytical method development up to NDA submission. Other companies include Celera, Pfizer/Pharmacia/Sugen and Roche Bioscience. Dr. Blasko is a Fellow of the Royal Society of Chemistry and a member of ACS, AAPS and FIP.


Imad A Haidar Ahmad

Imad A Haidar Ahmad is a principal scientist at the technical research and development department at Novartis Pharmaceuticals Corporation in San Carlos, CA. He earned his PhD in Analytical chemistry from Florida State University under Professor André Striegel’s supervision. His graduate work focused on studying structure-property relationships in polymers using multi-detection size-exclusion chromatography. Thereafter, He moved to University of Minnesota where he did his postdoctoral studies with Professor Peter Carr. In his postdoctoral work, he focused on learning the fundamental of separation science and two-dimensional liquid chromatography (2DLC). His current work is focused on analytical method development for complex separation, investigating analytical method problems using multidetection-2DLC, and analytical method validation.

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