“Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients,” reports this FDA news release, FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting - Focus on physical chemical identifiers.
The U.S. Food and Drug Administration (FDA) today issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug. This draft guidance is an important step in working with manufacturers to make drug products more difficult to duplicate by counterfeiters: Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (pdf).
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Wednesday, July 15, 2009
FDA Draft Guidance on Anti-Counterfeiting
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)
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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition
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