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GMP MANUAL
Created to keep professionals compliant with the ever-changing demands in the pharmaceutical industry.
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Question of the Week

What are the major trends that have changed the concept of validation recently?


Validation is understood as a lifecycle model instead of an isolated action.
Continuous data evaluation replaces gathering and archiving data as evidence.
Risk-based action replaces extensive action for maximum compliance.

[GMP MANUAL, Chapter 7.B.2.1]


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