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Pharmaceutical Manufacturing and Packing Sourcer
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The manufacture of injectable pharmaceuticals presents challenges from many perspectives, especially for products that must be processed aseptically and cannot be terminally sterilised. Food and Drug Administration (FDA) inspections for Good Manufacturing Practice (GMP) compliance in injectable drug product manufacturing facilities commonly find problems in the following areas:
Issues with environmental control
Problems with equipment, especially older equipment
Media fill failures and/or issues with media fills truly simulating actual practices
Lack of proper training of operators
Documentation failures
Besides the need to be in GMP compliance, manufacturing requires competency and resiliency in such matters as: inventory management, scheduling of facilities, equipment and personnel, management of changes in schedule, management of shutdowns for maintenance and repairs, management of change control, management of changes in product demand and departmental growth.
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By Trent Cox, Manager of Manufacturing and Michael Akers,
Director of Pharmaceutical R&D at Baxter Pharmaceutical Solutions LLC
Trent Cox earned a BS Degree in Biology from Indiana University. His career includes positions at Cook Pharmaceutical Solutions and Baxter Pharmaceutical Solutions, LLC in Bloomington. Trent is currently the Manager of Manufacturing for Baxter.
He has 10 years' experience in the pharmaceutical industry, most of which has been in contract manufacturing of injectable solutions. He has developed expertise in the areas of aseptic formulation and filling, process design and validation, environmental control and sterilisation technologies.
Michael Akers has a PhD degree in Pharmaceutics from the University of Iowa College of Pharmacy. His career includes positions at Searle Laboratories, Alcon Laboratories, the University of Tennessee and Eli Lilly. He is currently Director of Pharmaceutical R&D for Baxter Pharmaceutical Solutions, LLC in Bloomington.
Michael is active in the AAPS and PDA organisations. He is editor-in-chief of Pharmaceutical Development and Technology. He has published over 100 original research articles, review articles and book chapters. The 3rd edition of his book Parenteral Quality Control and a book co-edited with Steven Nail entitled Development and Manufacture of Protein Pharmaceuticals were published in 2002. Michael also continues to teach short courses in the area of sterile product formulation, manufacturing and quality.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
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News and Press Releases |
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