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  • Multivariate Calibration: A Science-Based Method

    A new method for multivariate calibration is less costly to implement than standard PLS or PCR methods, and eliminates the need to introduce additional variability into an otherwise stable process. It also allows specific responses to be proven from first principles.

    Ralf Marbach, VTT Optical Instruments Center
  • 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
  • From Procedural to Risk-Based Compliance and Enforcement

    In this presentation, ARC analyst John Blanchard outlines the steps required for moving from the old to the new model, and what they mean for pharmaceutical manufacturers and the FDA.

    John Blanchard, ARC Advisory Group
  • 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.
  • Benchmarking Report on Pharmaceutical Manufacturing

    This report, the result of extensive research by professors from Washington University and Georgetown University, examines cycle times, quality assurance, use of IT, employee empowerment and other factors at 42 drug manufacturing facilities to provide benchmarks.

    Jeffery Macher, Georgetown University, and Jackson Nickerson, Washington University
  • Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in Producing Viral Vaccines

    The U.S. Food and Drug Administration (FDA) on Sept. 28, 2006 issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines. The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines.

    FDA Center for Biologics Evaluation and Research
  • Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

    This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products.

    FDA Center for Drug Evaluation and Reseacb
  • Kick–Starting PAT to Achieve Quality by Design in cGMP Bioprocessing

    Since 2002, the FDA has promoted a continuous, process-centric approach to validation vs. the prior product–centric one. Yet, many pharma and biopharma companies have failed to incorporate that approach into their strategic plan. This white paper explains the new distinctions and what they mean in practice, then identifies PAT opportunities that can be implemented immediately to support QBD activities.

    TechniKrom, Inc.
  • New IR Calibration Technique Curbs Costs

    The standard industry practice of "statistical" calibration to achieve optical measurements is inefficient whenever a priori physical knowledge about the spectral signal and/or noise is available, argues Prof. Ralf Marbach of the Technical Research Center of Finland. In this white paper, Marbach describes a new method that cuts calibration costs by about one-third.

    Ralf Marbach, VTT Electronics, Technical Research Center of Finland
  • 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
  • FDA's Guidance on Effective Quality Risk Management

    FDA's guidance on effective quality risk management approach can ensure high quality of the drug product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing of pharmaceutical products.

  • Preventing Medication Errors Add Up Quality Chasm Series

    Study by the Institute of Medicine identifies frequency of medication errors and preventable adverse drug events and proposes a report on safe, effective, and appropriate use of medications, addressing the use of prescription drugs, OTC drugs, and complementary and alternative medications in hospitals and the community.

  • AstraZeneca Decided for Paperless Solution

    AstraZeneca opted for a paperless solution that would allow for data trending and a centralized, accessible calibration data base. It is cost effective.

    Anders Anlind
  • [Report on] the Food and Drug Administration’s National Drug Code Directory

    HHS’ Office of Inspector General found that the Directory is incomplete (with an estimated 9,187 prescription drug products missing) and inaccurate, (with an estimated 34,257 drug products no longer on the market or listed in error). The Office’s report also concluded that FDA’s drug product listing process and lack of oversight contribute to deficiencies in the Directory.

    U.S. Dept. of Health & Human Services' Office of Inspector General
  • 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
  • Raman Microscopy: An Essential Aid in Characterizing Drug Delivery Products

    Raman microscopy provides information about molecular organization and crystalline order at the resolution of optical microscopy at the sub micron scale, and is being used to characterize drug delivery materials. This white paper by Horiba Jobin Yvon discusses the mapping of creams, timed-release solids and stents, and how Raman maps provide hyperspectral cubes from which images can be reconstructed that show distribution, dissolution and molecular associations.

    Eunah Lee, Ph.D. and Fran Adar, Ph.D., Horiba Jobin Yvon
  • Assessment of Risk Factors in Container-Closure Systems

    This paper looks at applying Process Analytical Technologies to the lyophilization process to mitigate risk factors that could lead to producing a poor product. Dr. Jennings argues that risk can be lowered by increasing the number of samples, thereby raising the confidence level and reducing the confidence interval.

    Thomas A. Jennings, Ph.D., Phase Technologies Inc.
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