USFDA concludes inspection at Zydus with zero observations

The cGMP inspection concluded with nil observations

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USFDA Form 483
USFDA Form 483

Last Updated on November 11, 2024 by The Health Master

Zydus Lifesciences has announced that the group’s injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad, underwent USFDA inspection from 5th June to 13 June, 2023.

The cGMP inspection concluded with nil observations

This signifies that the facility has met the standards set by the current Good Manufacturing Practices (GMP).

The GMP ensures that manufacturing processes and facilities are designed, monitored, and controlled effectively, guaranteeing the production of safe and effective products that meet quality standards.

Understanding GMP, cGMP, and WHO-GMP

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