FDA White Papers & Case Studies
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White Paper: Pharmaceutical Sterility Testing — Essential Things You Must Know
6/7/2011
Sterility testing of pharmaceutical articles is required during the sterilization validation process as well as for routine release testing. An understanding of sterility testing is beneficial in terms of designing a validation process. By Steven G. Richter, Ph.D
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White Paper: Designing Biopharma And Pharmaceutical Cleanrooms
5/23/2011
Richard Paley of Bovis Lend Lease takes a look at the key issues in the design, specification and selection of cleanrooms, considering the impact on the final build solution and comparing different classes and finishes to show the advantages or disadvantages of each. By Bovis Lend Lease
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White Paper: Utilizing InfoBatch To Generate Clean-In-Place (CIP) Reports
4/22/2011
Many sterile manufacturing facilities find it difficult to manage Clean-in-Place (CIP) reports and are searching for a solution. InfoBatch is a flexible electronic batch reporting application that can be configured to create and maintain CIP reports for manufacturing facilities. By Informetric Systems Inc.
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Sparta Systems Success Story: Invacare Streamlines Complaint Management To Improve Customer Service Levels Worldwide
7/28/2010
Sparta Systems TrackWise solution enables Invacare to harmonize the complaint intake and investigation process globally, consolidating redundant systems, reducing manual operations, and reducing costs. By Sparta Systems, Inc.
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Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines
Although metal detection has been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants for decades in the pharmaceutical industry, it has not been widespread.
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How To Survive An FDA Audit
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
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DEA Imposes Extra Layer Of Regulations On Manufacturers Of FDA-Approved Prescription Drugs To Alleviate Pain
Because prescription pain medications too often have been diverted into the illegal drug trade, development, manufacturing, and distribution are much more complicated for these drugs than for other prescription therapeutics. To produce prescription pain medications in the U.S., manufacturing facilities must abide by the rules and regulations of two federal agencies: the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA), an arm of the U.S. Department of Justice that is charged with enforcing the Comprehensive Drug Abuse Prevention and Control Act, better known as the Controlled Substances Act (CSA).