White Papers & eBooks

on 'Facilty Design & Management'

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  • Facilities and Operational Investment 2016 eBook

    Pharma’s leaders continue to pursue success through a strategy of careful capital expenditure investment with an eye on increased capacity, speed and efficiency in their facilities.

  • eBook: Pharmaceutical Equipment & Manufacturing Trends

    The pharmaceutical manufacturing landscape has changed notably over the past decade and is continuing to evolve rapidly. Pharmaceutical manufacturers have begun to wield some new tools, nailing down new efficiencies and better drugs in the process.

  • Special Report: Facilities of the Future - Agile and Flexible

    Just a decade ago, it could take four to six years to bring a new biopharma plant onstream. Today, thanks to modular construction and single-use processing equipment, a multipurpose facility can be brought online in as little as 12 months. Timelines are shrinking to a point where they may soon be measured in months. In this Special Report e-Resource, experts in designing, implementing and operating these facilities explain the quickly changing ground rules and what they mean for the industry, and share best practices.

  • Use of Universal HPLC Detection for Cleaning Validations

    Several methods and traditional cleaning solvents for manufacturing devices spiked with typical drug substances and impurities were measured using HPLC-UV and CAD detection. HPLC with CAD provides a more complete view of the data since the CAD response has less solvent interferences and does not require the presence of chromophores for detection.

    ESA Biosciences, Inc.
  • Five Key Steps to Minimizing Risk During GMP Site Renovations

    Renovating any facility while manufacturing is going on poses a number of risks. This position paper by John Buescher and Tom Kreher of McCarthy Building Companies outlines top priorities and how to address them.

    John Buescher and Tom Kreher, McCarthy Building Companies
  • 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
  • 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
  • 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.

  • [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
  • Process Modeling and Control Challenges in the Pharmaceutical Industry

    In this 2003 presentation made at a conference held by the University of Texas, Phil Dell'Orco, GSK's Leader for Process Safety and Design, summarized the challenges facing engineers as they work to improve control of pharmaceutical processes in an industry still dominated by chemists.

    Phil Dell'Orco, GlaxoSmithKline
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