White Papers & eBooks

on 'Packaging'

21-40 of 58 < first | | | last >
  • Pharmaceutical and Biotechnology Update : Drug Pedigrees

    This update summarizes the pending Prescription Drug Marketing Act requirements, highlights pedigree requirements in Florida and California, and raises issues for consideration.

    Meredith Manning, Michael L. Kidney, and Ellen Y. Chung, Hogan & Hartson
  • A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials

    This comprehensive guide written by The Institute of Quality Assurance is aimed at increasing the awareness of the quality management system requirements embodied in PS 9000. It adopts a risk assessment approach to the identification and implementation of preventive action and uses case studies to illustrate areas of GMP risk.

    The Institute of Quality Assurance
  • FDA-CDER Compliance Policy Guide for the PDMA

    This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203 during the first year after the effective date of 21 CFR §§ 203.3(u) and 203.50.

    FDA Center for Drug Evaluation and Research
  • Anyone Who Says RFID is Completely Secure…

    Forrester analyst Paul Stamp and his colleagues find that middleware is a weak point, but the tags themselves are the technology’s Achilles heel.

    Paul Stamp et al, Forrester Research, Inc.
  • Global Security Study: Perspectives for Life Sciences

    While facing an era of new regulatory and marketplace pressures, the life sciences industry is placing more emphasis on the areas of security, information protection and data privacy issues within their organizations. Two key findings: The number of major life sciences firms that employ chief security officers has grown three-fold since 1996, and those officials are increasingly adding RFID to their defense tactics.

    Deloitte Touche Tohmatsu
  • RABS: Injecting Change into Syringe Drug Delivery

    Routine administration of injections involves several risky steps: Was the needle really sterile? Is that drug really in order? Was the dosage accurate? And what happens to those few drops of costly drug that remain at the bottom of the vial? Joerg Zimmerman of Vetter reveals an innovative method of aseptic filling for syringes, which reduces such risk involved in intravenous drug delivery systems.

    Joerg Zimmermann, head of production, Vetter Pharma
  • Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process

    In 2004, several high-profile drug safety cases raised concerns about the FDA's ability to manage postmarket drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. In this report GAO (1) describes FDA’s organizational structure and process for postmarket drug safety decision making, (2) assesses the effectiveness of FDA’s postmarket drug safety decision-making process, and (3) assesses the steps FDA is taking to improve postmarket drug safety decision making.

    U.S. Government Accountability Office
  • Choosing the Right Partner in the Drug Pedigree Race

    This paper aids companies working to comply with current or emerging drug pedigree legislation by providing information critical to making an implementation decision. Herein, VeriSign identifies the drivers for implementing a pedigree solution; summarizes the minimum requirements of an electronic pedigree solution; discusses high-level factors inherent in meeting pedigree requirements that influence complexity, risk, and cost; and outlines questions to ask when choosing an e-pedigree solution partner.

  • Build Your Pedigree Platform

    VeriSign outlines the fundamentals of a serious e-pedigree program.

    Bruce A. Harder, Sr. Manager, Healthcare and Life Science Solutions, VeriSign
  • Phase Transformation in Solid Pharmaceutical Materials

    This 72-page PDF, a dissertation by Denny Mahlin at Sweden's Uppsala Faculty of Pharmacy, discusses results of using atomic force microscopy and other techniques to study solid mixtures for solid dosage forms.

    Denny Mahlin, Uppsala Faculty of Pharmacy
  • Possible Scenarios for Private-Sector Use of RFID

    What will the future of RFID be? This chapter from Addison-Wesley’s new “RFID: Applications, Security and Privacy,” examines possible scenarios for private-sector use of RFID, from “Shangri-La” to “The Wild West.”

    Ari Schwartz and Paula Breuning
  • Marking Pharmaceutical Ingredients for Solid Dosage Security

    Molecular Recognition Marking offers a proven, FDA-approved method of forensic authentication. Dr. Jim Rittenburg of Authentix details how the technology works, and gives us an inside look at how drug makers are marking their drugs.

    Jim Rittenburg, VP for Pharmaceuticals, Authentix
  • RFID Can Be Hacked

    The technology can be altered with the help of a humble home computer. Reconnaissance International’s Ed Dietrich examines the problem.

    Ed Dietrich, Reconnaissance International
  • Exclusive Excerpt: Garfinkel and Holtzman on RFID

    Here’s everything you need to know about RFID technology, from two IT pioneers, Simson Garfinkel and MIT’s Henry Holtzman. This 22-page PDF is Chapter 2 of the new “RFID: Applications, Security and Privacy,” published by Addison-Wesley.

    Simson Garfinkel and Henry Holtzman
  • Recommendations on Auto ID for Medical Devices

    With barcoding and RFID recommendations less clear for the device industry, FDA contracted the nonprofit group ECRI to survey the broad Auto ID landscape. This paper details ECRI's findings.

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