OR WAIT null SECS
August 01, 2005
New maintenance models focused on efficiency improvements can deliver cost savings and enhanced service quality.
Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.
July 21, 2005
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July 13, 2005
Able Interim Chief Resigns Amid Drug Recall
July 02, 2005
Police and protests at BIO 2005.
A stepwise, process risk-assessment approach can facilitate the identification and understanding of critical process parameters, quality attributes, and in-process controls. This approach can lead to more use of science- and risk-based regulatory practices to simplify the regulatory requirements for changes to synthetic processes and to support the underlying quality systems that ensure compliance.
June 30, 2005
Warning Letter: Pragmatic Materials
June 09, 2005
Warning letter: C&M Oxyfill
June 02, 2005
In his Feb. 2005 viewpoint article, "In Defense of Singlet Testing," Torbeck (1) draws an important philosophical distinction between "standards" and "specifications." He argues that specifications are criteria selected by manufacturers for statistical control of their products, whereas compendial standards are absolute requirements. This distinction is entirely compatible with modern concepts of statistical process control.
Purdue?s RFID Pedigree Program Enters Pilot Phase