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What is Understanding GMP Failures in Pharma about?

The document discusses detecting failures in quality management systems for the pharmaceutical industry. It outlines two reasons why examining nonconformances and deviations is important: 1) to continuously improve processes, and 2) to meet increasing regulatory requirements. Common industry failings include not completing investigations and corrective actions in a timely manner. The document also provides guidance on identifying and documenting nonconformances, detecting root causes, and defining and imple

Author

bsetiawan

Language

EN