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Pharmaceutical Engineering Archives |
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November/December 2003| The Road to Cleanroom Compliance by Bob Cates & Larry DeShane This article discusses how to operate and maintain an effective cleanroom program to meet pharmaceutical industry compliance regulations.  Download Article... |
Risk Assessment for Use of Automated Systems Supporting Manufacturing Processes Part 2 - Risk to Records by ISPE GAMP Forum This article demonstrates how the risk analysis guidance in GAMP 4 can be applied to GMPs and Good Distribution Practices (GDPs). Download Article... |
Recommendations for Implementing a Calibration Program by Yefim S. Gudesblat, PE This article presents the infrastructure of a GMP compliant Calibration Program based on technical and metrology methods. Download Article... |
Legacy Systems: GAMP Good Practice Guide: The Validation of Legacy Systems by ISPE GAMP Forum This Guide discusses the considerations which should explain this activity and suggests a process to be followed in order to assess and validate Legacy Systems. Download Article... |
Evaluating Current Trends and Technology for Laboratory and Developmental Facilities What’s Right for Your Project? by Bob McCleskey This article presents current trends and technology in laboratory and development facility projects. Download Article... |
New Laboratory Design Helps Speed Up Research by David Withee This article describes a new, costeffective design method for increasing productivity in new or renovated laboratories. Download Article... |
Filling Equipment with Barrier Isolators - Reference List December 2002 by Jack Lysfjord This supplement to the article "Barrier Isolation History and Trends" contains the complete survey raw data matrix. Download Article... |
Country Profile: Australia by ISPE Australia Affiliate This section takes a look at the pharmaceutical industry in Australia; produced in collaboration with ISPE Australia. Download Article... |
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