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Compliance is widely-accepted as the best way to conduct business, putting product quality first.

A project is temporary in that it has a defined beginning and end in time. A project is unique that it is not in routine operation. Efficient and well-structured project management is the basis for a successful goal.

The validation of a manufacturing process requires a suitable operating environment. This entails operating procedures, good methods and practices, trained personnel…and, in addition to this, the qualification of the facilities, equipment and utilities involved in the process.

An effective quality system should help ensure compliance with compliance with cGxPs.