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Tag: critical major minor observations

GMP Inspection Terminology and Classification Systems Used by Regulators

Posted on May 21, 2025 By digi

GMP Inspection Terminology and Classification Systems Used by Regulators Decoding Inspection Terminology and Classification Systems in GMP Compliance Effective communication in the context of GMP inspections depends on the consistent use and understanding of regulatory terminology. Terms such as “critical”, “major”, and “minor” carry specific meanings that directly impact regulatory outcomes. For pharmaceutical manufacturers operating…

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Global GMP Inspection Frameworks, International GMP Inspection Standards and Harmonization

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