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The 2026 edition provides comprehensive explanations of the latest regulations, fully compliant with domestic CSV guidelines, covering PIC/S, FDA, EU GMP, CSA, and Annex 11/22 (AI). It is aimed at professionals involved in Computerized System Validation (CSV), quality assurance, quality control, regulatory affairs, IT system implementation, and compliance.
This publication provides a comprehensive overview of the ICH Q9(R1) guidelines on Quality Risk Management (QRM), detailing the background, objectives, and key revisions. It explores the implications of these guidelines on formulation development, offers training material summaries, and discusses the interplay of knowledge management and subjectivity within QRM. Additionally, it presents case studies from various enterprises and examines the integration of knowledge management into business models and pharmaceutical quality systems.
