» Featured Article |
How To Implement Proper Gowning Procedures In An OSD Facility |
By Christine Hofnagel, AIA Associate, JacobsWyper Architects Within an oral solid dosage (OSD) manufacturing facility there are typically three levels of product exposure: general, protected, and controlled. Generally, the division of levels is directly related to the product or product component exposure, as well as to the physical environment and function within the facility. These levels vary, as many manufacturing processes differ from site to site. This article addresses specific gowning regulations for each of the three levels, as well as how to achieve them with a quality risk assessment program. |
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» QA/QC |
WHITE PAPER: Serialization And The Drug Quality And Security Act: A Top-Down Synergistic Approach |
By Glenn Restivo, Mike Salinas, M&W Group, and David DeJean, Systech International Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA). |
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