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Topic: Packaging
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Heparin Drama Underscores Need for More FDA Funding and Supplier Oversight
Drug Delivery and QbD: A Collision of Lifecycles
Applying the Final Touches
Packaging Simulation Answers the Need for Speed |
White Papers: In depth research
| Title | Author | Date |
| Nanoparticles in Pharmaceutical Manufacturing | NETZSCH Fine Particle Technology, LLC | 04/14/2008 |
| The paper explores the rapidly expanding role and significant performance advantages of nanoparticles in pharmaceutical applications. It provides an overview of nanoparticle uses in applications including diagnostic products, product packaging and biomarker discovery, as well as an extensive look at nanoparticle use in drug delivery. The paper also describes the ability to create nanoparticles efficiently and economically with media milling. | ||
| Final Bulk Inspection of Solid-Dose Pharmaceuticals | Symetix | 02/08/2008 |
| Advancing technology is redefining diligence in pharmaceutical manufacturing and packaging. Learn the pros and cons of sampling, manual inspection, mechanical sorting and vision inspection systems in this white paper by Symetix. Plus, discover how continuous, fully-automated bulk optical inspection systems are more viable than ever. | ||
| Review of RFID in 2007 | Raghu Das | 01/15/2008 |
| In the build up to the annual IDTechEx RFID USA event in Boston this February and the latest IDTechEx RFID forecasts, Raghu Das reviews RFID progress in 2007. | ||
| The Impact of Nanotechnology in Drug Delivery: Global Developments, Market Analysis, and Future Prospects | NanoMarkets, LC | 11/01/2007 |
| This report by NanoMarkets, LC includes an overview of nanoenabled drug delivery technologies, commercial applications and information on the companies pursuing them, information on nanotechnology initiatives and regulation in major international markets (North America, EU, Japan, Israel, etc.), as well as eight-year worldwide forecasts on the industry’s anticipated growth and timing thereof. | ||
| A National, Uniform Paper Trail for Drugs? | Peter S. Reichertz and Deborah M. Shelton, Sheppard Mullin Richter & Hampton | 08/28/2007 |
| Pending “pedigree” requirements will bring new uncertainties. | ||
| Pharmaceutical and Biotechnology Update : Drug Pedigrees | Meredith Manning, Michael L. Kidney, and Ellen Y. Chung, Hogan & Hartson | 08/28/2007 |
| This update summarizes the pending Prescription Drug Marketing Act requirements, highlights pedigree requirements in Florida and California, and raises issues for consideration. | ||
| Drug Pedigree: Does It Matter to Manufacturers? | Todd Applebaum and Uriel Kusiatin, Maxiom Group | 08/28/2007 |
| Manufacturers, and particularly those producing drugs meeting certain counterfeiting risk factors, cannot afford to ignore current and upcoming developments in pedigree regulations. | ||
| A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials | The Institute of Quality Assurance | 07/16/2007 |
| 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. | ||
| U.S. Packaging Machinery Purchasing Plans Study : Pharmaceuticals and Medical Devices | PMMI | 06/12/2007 |
| PMMI in their 2007 U.S. Packaging Machinery Purchasing Plans Study find that U.S. manufacturers of pharmaceuticals and medical products – as a combined group – intend to increase spending for packaging machinery by approximately +2% to +4% in 2007 to an estimated (mid-point) volume of $803 million. | ||
| FDA-CDER Compliance Policy Guide for the PDMA | FDA Center for Drug Evaluation and Research | 11/13/2006 |
| 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. | ||
| Anyone Who Says RFID is Completely Secure… | Paul Stamp et al, Forrester Research, Inc. | 10/17/2006 |
| Forrester analyst Paul Stamp and his colleagues find that middleware is a weak point, but the tags themselves are the technology’s Achilles heel. | ||
| Global Security Study: Perspectives for Life Sciences | Deloitte Touche Tohmatsu | 09/18/2006 |
| 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. | ||
| RABS: Injecting Change into Syringe Drug Delivery | Joerg Zimmermann, head of production, Vetter Pharma | 08/14/2006 |
| 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. | ||
| Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process | U.S. Government Accountability Office | 04/24/2006 |
| 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. | ||
| Choosing the Right Partner in the Drug Pedigree Race | VeriSign | 04/12/2006 |
| 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. | ||
| Secrets to H.D. Smith’s Success with E-Pedigree | GlobeRanger | 03/16/2006 |
| Track-and-trace technology provider GlobeRanger describes how drug distributor H.D. Smith is leveraging its RFID infrastructure for e-pedigree. | ||
| Build Your Pedigree Platform | Bruce A. Harder, Sr. Manager, Healthcare and Life Science Solutions, VeriSign | 03/15/2006 |
| VeriSign outlines the fundamentals of a serious e-pedigree program. | ||
| Aqueous Film Coating of Tablets in a Side-Vented Pan Coater | Mirja Ruotsalainen, Helsinki University | 02/20/2006 |
| This 53-page thesis by Mirja Ruotsalainen at Helsinki University, Finland, examines the impact of coating and storage on surface morphology, moisture control and stability. | ||
| Phase Transformation in Solid Pharmaceutical Materials | Denny Mahlin, Uppsala Faculty of Pharmacy | 02/20/2006 |
| 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. | ||
| Possible Scenarios for Private-Sector Use of RFID | Ari Schwartz and Paula Breuning | 02/08/2006 |
| 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.” | ||
| Marking Pharmaceutical Ingredients for Solid Dosage Security | Jim Rittenburg, VP for Pharmaceuticals, Authentix | 01/12/2006 |
| 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. | ||
| RFID Can Be Hacked | Ed Dietrich, Reconnaissance International | 01/12/2006 |
| The technology can be altered with the help of a humble home computer. Reconnaissance International’s Ed Dietrich examines the problem. | ||
| Talk to Me, Supply Chain: Voice-Activating the Warehouse | Greg Aimi, AMR Research | 01/12/2006 |
| Voice-directed work in the warehouse is coming of age, and has the potential to enhance warehouse productivity and safety, says AMR Research’s Greg Aimi. | ||
| Exclusive Excerpt: Garfinkel and Holtzman on RFID | Simson Garfinkel and Henry Holtzman | 01/11/2006 |
| 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. | ||
| Recommendations on Auto ID for Medical Devices | ECRI | 12/07/2005 |
| 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. | ||
| Cold Chains Are Hot: Mastering the Challenges of Temperature-Sensitive Distribution in Supply Chains | Carla Reed, Chain Link Research | 10/11/2005 |
| Unlike food products, pharmaceutical products' quality can be compromised without any visible cues. That makes proper handling of temperature-sensitive drugs all the more critical and all the more challenging. This white paper from Cold Chain Research discusses best practices and promising technologies. | ||
| Meeting the Counterfeit Drug Challenge | Peter J. Pitts, senior fellow, Pacific Research Institute | 09/16/2005 |
| Think-tank fellow and former FDA associate commissioner Peter Pitts discusses what can be done about the growing global public health threat posed by drug counterfeiters. | ||
| What’s Your Security Confidence Rating? | Andrew Dubner, 3M senior specialist | 09/15/2005 |
| Securing the pharmaceutical supply chain requires a multilateral approach, with high confidence in all aspects. An authenticated RFID system is a critical component, explains Andrew Dubner, 3M senior specialist and Six Sigma Black Belt. | ||
| Using RFID and PKI to Secure the Pharma Supply Chain | Texas Instruments | 09/15/2005 |
| It’s a marriage of two of the hottest security technologies — radio frequency identification and public key infrastructure. Texas Instruments offers tips for a happy union. | ||
| CDER's 2004 Report to the Nation: Improving Public Health Through Human Drugs | FDA's Center for Drug Evaluation and Research | 08/23/2005 |
| This 66-page report discusses what was accomplished by FDA's Center for Drug Evaluation and Research in 2004, and looks at the initiatives it will be tackling this year and in the near future. | ||
| Total Bar Code Quality | Quint Company | 08/11/2005 |
| The quality of each bar code is not always black and white, and manufacturers need means of verification to determine the effectiveness of each code and label. This succinct but substantive paper by platemaker Quint Co. sheds light on verification methods and bar code standards. | ||
| Don't Say 'Used': How to Select Pre-Owned Equipment | Frain Industries | 07/21/2005 |
| Buying pre-owned equipment can be risky, but it can also save money and increase production if you know what to look for. Frain Industries' K.C. Christensen offers tips for smart shopping. | ||
| Logistics, the Next Generation | Magnar Løken d.y., CEO, Kezzler AS | 07/14/2005 |
| Logistical and manufacturing systems must merge and evolve with tracking technologies if the supply chain is to be truly secure. Magnar Løken d.y., CEO of Norwegian software firm Kezzler AS, shows how it’s done. | ||
| The Complete Word on Supply Chain Risk | Product Surety Center | 06/30/2005 |
| The 2005 Symposium on Risk in Supply Chains was the place to be for progressive thought on supply chain issues. Here are summaries of all key presentations. | ||
| Pharma Labels Fail the Toughness Test | Donald L. Gibbon, Matco Associates, Inc. | 06/23/2005 |
| An independent lab tested a variety of pharmaceutical product labels for durability when exposed to harsh elements such as heat, moisture and household chemicals. The elements won. | ||
| RFID for the Real World (in English) | FKI Logistex | 06/22/2005 |
| FKI Logistex offers an analysis of the challenges of RFID adoption and a common-sense, measured response to intelligently evaluating and implementing RFID. | ||
| RFID for the Real World (en Español) | FKI Logistex | 06/21/2005 |
| FKI Logistex offers (in Spanish) an analysis of the challenges of RFID adoption and a common-sense, measured response to intelligently evaluating and implementing RFID. | ||
| Inventory Management Agreements: Challenge in the Channel | Pembroke Consulting | 05/20/2005 |
| Recent Inventory Management Agreements (IMAs) between drug manufacturers and wholesalers may have created unintended industry consequences such as increasing the risks and velocity of drug product shortages and imposing additional costs on as hospitals and pharmacies. In this white paper, Pembroke Consulting takes a critical look at the inventory impact of IMAs on companies such as Merck, Pfizer, BMS, and The Big Three drug wholesalers. | ||
| Extracting Value from RFID in Warehousing Applications | Rockwell Automation | 04/29/2005 |
| This White Paper from Rockwell Automation discusses how RFID can be used most effectively to improve warehouse efficiency and ROI. | ||
| Giuliani Report: Imports Carry Terror and Health Risks | Giuliani Partners | 04/14/2005 |
| A PhRMA-sponsored report by Giuliani Partners states unequivocally that every effort to open borders to broader drug importation should be resisted. Drug fakes are already compromising the system, it says, and carry links to organized crime and terror groups. | ||
| Track and Trace in the Cold Chain | Sensitech | 04/14/2005 |
| Active RFID tags with temperature capabilities are one way to give cold chain products special attention. | ||
| Mandatory Reporting is the Key to Eradicating Counterfeit Drugs | Robert Cockburn, Paul N. Newton, E. Kyeremateng Agyarko, Dora Akunyili, Nicholas J. White | 04/14/2005 |
| Numbers are bandied about on the extent of counterfeiting, but these figures are probably low. By how much? Will we ever know? Closer connection between government and industry, and ongoing reporting, will be essential in finding out, say the authors. | ||
| FTC RFID Workshop Report | Federal Trade Commission | 03/11/2005 |
| The Federal Trade Commission recently issued a thorough report summarizing issues and drawing conclusions from a June 2004 workshop entitled "Radio Frequency Identification: Application and Implications for Consumers." The one-day workshop brought together retailers, RFID suppliers, government officials, trade associations, researchers and consumer advocates to discuss current and future issues and to outline best practices. | ||
| Don't Overlook Legal and Privacy Issues Posed by RFID | Ronald E. Quirk, Jr. and Stacia J. Borrello, Venable | 02/09/2005 |
| RFID poses serious legal and regulatory issues to manufacturers and plant owners. In this new white paper, former FCC senior attorney Ronald E. Quirk, Jr. and Stacia J. Borrello, both of whom work for the regulatory legal firm Venable, outline the legal complications of RFID and an electronic drug pedigree. | ||
| Case Study: Fast Checkouts Achieved through RFID | RF Code, Inc. | 01/13/2005 |
| This case study details how pH Europe, a leading container rental firm, improved customer service, improved its command of the supply chain and reduced its overall costs through the use of innovative track-and-trace software from RF Code, Inc. | ||
| Online Education on RFID Package Tagging Basics | 11/19/2004 | |
| Trade Shows are Good for You | 11/18/2004 | |
| Jump-Starting RFID in the Pharmaceutical Supply Chain | Accenture | 11/16/2004 |
| A group of pharma manufacturers, wholesalers, retailers and associations cooperated on a landmark project to determine the costs and benefits of adopting RFID and EPC across the value chain. Accenture's executive summary discusses what was learned in Phase 1 of the project. | ||
| A Closer Look at Low-Frequency RFID | 11/16/2004 | |
| RFID's Frequency Controversy | 11/15/2004 | |
| RFID in Manufacturing: Mandated Supply Chain Monitoring | 10/29/2004 | |
| Long-term Benefits of Adopting RFID Technology | Rockwell Automation | 10/28/2004 |
| Wal-Mart's mandate that its top suppliers must put RFID tags on cases and pallets of consumer goods by January 2005 has pushed manufacturers toward the technology, despite reservations about ROI. Rockwell Automation's "RFID in Manufacturing" White Paper provides a practical guide to extracting measurable value from RFID implementations in plant and warehousing operations. | ||
| Understanding the Overload Set Point in Tablet Press Operations | 10/22/2004 | |
| Teva Saves Big Through Desiccant Automation | 10/21/2004 | |
| Improving Cancer Drug Delivery through Micro Technology | 10/19/2004 | |
| Pharma 2010: The Threshold of Innovation | IBM Business Consulting Services | 10/19/2004 |
| The pharmaceutical future belongs to companies able to deliver "targeted treatment solutions," claims this visionary report, part of IBM Business Consulting Services Pharma 2010 series. This brief but sweeping report focuses on how firms can get ahead and stay ahead in the targeted treatment game. | ||
| Want Cheaper RFID? Go Offshore | 10/16/2004 | |
| The Growing Need for Desiccant Solutions in the Pharmaceutical Industry | 10/14/2004 | |
| Challenge and Opportunity on the Critical Path to New Medical Products | 10/14/2004 | |
| RFID Labeling Guidance from AIM | 10/13/2004 | |
| Initial ruling in Fagan vs. Amerisourcebergen, Amgen, CVS Procare and John Doe Corporations | 08/04/2004 | |
| More White Papers » | ||
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