The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance
European Pharmaceutical Review
MARCH 8, 2024
As for its benefits in pharmacovigilance, the paper explained that GAMP 5 “helps organisations maintain high-quality standards in adverse event reporting and analysis, ensuring the safety of patients and the integrity of data. GAMP 5 update: computerized system expectations for pharma manufacturers Benefits of Pharma 4.0 Pedro et al.
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