BioPharm International Supplements, September 2006 - BioPharm International

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BioPharm International Supplements, September 2006
Articles
Achieving Global Consensus through the International Conference on Harmonization
By Zena G. Kaufman , Diano Beno
The concept of design space has started a minor revolution in our industry.
Assuring the Effective Use of Standard Operating Procedures (SOPs) In Today's Workforce
By David C. Peterson
SOPs are written job aids that detail the procedure of how to do a specific job task correctly.
Expediting the Technical Transfer of Biopharmaceutical Products
By Luz Hermida-Matsumoto , Anita Grochulski , Sam George
Established, fully validated methodology and SOPs are required prior to initiation of any training activities.
Asset Management for Growing Biotech Companies
By James Erickson
The challenge is to determine the optimal frequency for preventive maintenance and the optimal frequency and tolerances for calibration readings.
Navigating Differences Between FDA and EMEA for Regulatory Compliance During Drug Development
By John Simmons , David Bernstein
While not yet finalized and adopted, ICH Q10 represents some of the most current thinking with respect to pharmaceuticals manufacturing and control.
The Laboratory Control System: Fulfilling cGMP Requirements
By Elizabeth Thomas , Anita Grochulski , Ripal Patel , Sam M. George , Ling-Zhang
Reserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.
Writing Effective Development Reports
By Paula J. Shadle, PhD
Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.

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