Volume 23, Number 6
by Jerold W. Boddy, Kevin Scannell
This article addresses opportunities to find efficiencies and savings along the spectrum of critical services that includes design, commissioning, and validation.
by Bob Cates, Larry DeShane
This article discusses how to operate and maintain an effective cleanroom program to meet pharmaceutical industry compliance regulations.
This article demonstrates how the risk analysis guidance in GAMP 4 can be applied to GMPs and Good Distribution Practices (GDPs).
by Yefim S. Gudesblat
This article presents the infrastructure of a GMP compliant Calibration Program based on technical and metrology methods.
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.
by Bob McCleskey
This article presents current trends and technology in laboratory and development facility projects.
by David Withee
This article describes a new, costeffective design method for increasing productivity in new or renovated laboratories.
This section takes a look at the pharmaceutical industry in Australia; produced in collaboration with ISPE Australia.
by Brendan Barry, Nigel de Haas
This article presents the issues that need to be addressed when developing and operating aCalibration Management Program with emphasis on European regulations.
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