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  • Understanding Variability, its Sources and its Impact on the Pharma Supply Chain

    How one pharmaceutical company used the fundamentals of variability analysis to analyze release and stability failures, gain control of its supply chain, and save millions of dollars by identifying and eliminating the causes of those failures.

    Fernando Portes, Principal Project Manager, Best Project Management
  • When Less is Much, Much More

    Microreactors are challenging the concept of "economies of scale."

    Angelo De Palma, Ph.D., Contributing Editor
  • Organichem Lays a Foundation for Growth

    A new building management system has helped the contract manufacturer automate pressurization control and expand potent compound manufacturing.

    Paul Thomas
  • Cook Pharmica Serious about Developing Expertise Locally

    Between establishing a biotech internship program with Indiana University and co-creating the Indiana Life Sciences Education and Training institute, Cook Pharmica is putting its money and efforts right where it said it would.

  • Contract Research Drives China's Pharma Sector

    Contract research is both a vehicle for Chinese pharmas to expand their R&D expertise and quality levels, and a bridge for them to enter global markets.

    Yibing Zhou, BioPlan Associates, Inc.
  • There's No Such Thing as a Free Lunch

    Pharmaceutical companies are facing increasingly intense scrutiny of their marketing and advertising practices, not only from federal agencies but state authorities as well.

    Ronald W. Buzzeo, R.Ph., chief regulatory officer, Dendrite International
  • PAT in Perspective: Drugs Are Not Potato Chips

    Although PAT and technologies like NIR are important, there still are things that they cannot do, concedes NIR expert Emil Ciurczak. Are advocates within the industry suspending rational and much needed skepticism, he asks, when they talk about eliminating final product stability testing altogether?

    Emil W. Ciurczak, Cadrai Technology Group
  • Innovations in Batching, Dosing and Weighing

    Challenges brought on by new regulations and technical problems for batching, dosing and weighing have pushed users to find some innovative and surprising solutions beyond the automation industry.

    Dave Harrold, co-founder of the AFAB Group
  • Risk Management, the Right Way

    When risk management techniques are applied to selecting the most appropriate project management organization, the chance of project success soars.

    John Nita and Luiz Correa, Emerson Process Management
  • FDA's Gottlieb Critiques Clinical Trial Design

    In addressing the recent Conference on Adaptive Trial Design in Washington, D.C., Scott Gottlieb, MD, FDA Deputy Commissioner for Medical and Scientific Affairs, applauded recent progress in the evolution of sophisticated drug development tools. However, he also expressed concern over the design of clinical trials and called for a move toward a more adaptive approach.

  • CAPA and Root Cause Analysis

    Recent FDA Warning Letters have cited insufficient corrective and preventive action (CAPA) programs as major compliance weaknesses. How does one ensure one’s CAPA is on the right track? Doug Bartholomew interviews industry QA professionals and leading consultants for the answers.

    Doug Bartholomew, Contributing Editor
  • Economies of Scale for Manufacturing

    Eli Lilly’s process engineering manager Pankaj Mohan shares the technical and management secrets for ensuring the right economy of scale for any pharmaceutical manufacturing process.

    Pankaj Mohan, management leader, global process engineering, Eli Lilly
  • Lutter Briefs House Subcommittee on FDA's Anti-Counterfeiting Action Plan

    Randall W. Lutter, Ph.D., FDA's Associate Commissioner for Policy and Planning, on July 11 addressed the House Committee on Government Reform's Subcommittee on Criminal Justice, Drug Policy, and Human Resources. He reported on the progress — and lack thereof — that FDA and industry have made toward the goals outlined in the Agency's "Combatting Counterfeit Drugs" report.

  • Reading Between the Lines of FDA’s Counterfeit Drug Report

    In June, FDA’s Counterfeit Drug Task Force issued a long-awaited report that signaled the Agency’s current thinking on RFID, drug pedigrees and other issues critical to supply chain security. ABI Research analyst Sara Shah has taken a fine tooth comb to the report, and tells us what FDA is really saying, and what it’s not.

    Sara Shah, Industry Analyst, ABI Research
  • Will Near-Field UHF Be Pharma’s Item-Level Savior?

    Near-field UHF RFID has created a buzz in the drug industry, raising the possibility of an end-to-end UHF-enabled supply chain — which would significantly hold down costs of RFID implementation. Proponents say that the performance of NF could rival high frequency (HF) at the item level. This exclusive excerpt from a recent report by IDTechEx discusses the technology and how it stacks up against HF.

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