PREFACE
As the validation master plan execution program proceeds and the facility is integrated
into regulatory guidelines of the FDA, cu
rrent good manufacturing practice (cGMP),
good laboratory practice (GLP), and th
e need for comprehensive and well-defined
validation supporting standard operating procedures are required. As the validation
program progresses and the systems are inte
grated into routine operation, there are
fewer deviations and the standard operat
ing procedures become more precise and
complete.
As the validation master plan execution program proceeds and the facility is integrated
into regulatory guidelines of the FDA, cu
rrent good manufacturing practice (cGMP),
good laboratory practice (GLP), and th
e need for comprehensive and well-defined
validation supporting standard operating procedures are required. As the validation
program progresses and the systems are inte
grated into routine operation, there are
fewer deviations and the standard operat
ing procedures become more precise and
complete.