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GAMP Good Practice Guide: Enabling Innovation

Published: September 2021
Pages: 102

The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient.

To get more information about this Guidance Document, please visit the ISPE global site.or contact ISPE Shanghai by email at

This Guidance Document is currently not available in Chinese.

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