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How to Respond to (& Avoid) FDA 483s (.pdf)
No cGMP compliant manufacturer wants to receive a Form 483 ("Notice of Inspectional Observations"). In such stringently controlled industries as pharmaceutical/biotechnical development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality
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Cut Your Outsourcing Risks
Although toll processing relationships now are pervasive in the pharmaceutical industry, resources dealing with the operational, safety, contractual, legal, regulatory and other aspects of these transactions are quite limited. Indeed, with respect to pharmaceutical contract manufacturing
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Interphex 2005 Conference & Exhibition Preview
Materials Booth 1884 The Model DS-22 disintegrator from features dual cutting mechanisms to reduce up to 1800 lbs. of waste per hour down to particles as small as 3/32 in. The system is ideal for the destruction of returned, expired or off-spec pharmaceutical products. Pharmaceutical and Biotech
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Weigh the Risks in Outsourcing Decisions
and other identifiers. At sterile package manufacturer West Pharmaceutical Services (Lionville, Pa.), the company must rigorously control distribution of its seals and stoppers, to the point of instituting special warehousing and inventorying and destroying scrap materials. "We even disguise our
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Extending the Validated Workplace
tried to structure its BAS offerings to the pharmaceutical industry by bundling solutions for four distinct areas: laboratories, animal-research facilities, manufacturing, and warehousing. "There's a specific problem with many facilities whose workspace is continually changing," notes Diane Welpe
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e-Pedigrees: Change During a Time of Uncertainty
on the scanning and authenticating of serial numbers. We know there are also very capable solution providers on the warehousing side as well, and they're focused on addressing these issues about serialization and the transaction volumes. Of the pharmaceutical company. Pharmaceutical e-Pedigree
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Pfizer Learns by Doing with RFID
By Paul Thomas, Managing Editor Ambient moisture and humidity are also thought to impact signal strength and thus read rates. While pharmaceutical production and warehousing areas tend to be humidity-controlled, have you had any issues along these lines? This is a fact and I believe there are even
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Accessing Plant-Floor Intelligence
The pharmaceutical industry is embracing enterprise resource planning (ERP) and the concept of Service-Oriented IT Architecture, with a growing number of manufacturers building platforms based on SAP or Oracle. However, drug manufacturers have also recognized the limits of such systems. As John