Practical EU GMP Audit Check List & GAP Analysis

Continual improvement is a critical part of quality professionals in all industries. A pharmaceutical quality system requires solid knowledge management and training regarding personnel competence. There might be some GMP Checklists available from other sources than EU GMP for Medicinal Products. During GMP Lead Auditor training, and as a part of the preparation to become an Internal auditor, the idea was born. Due to ongoing updates in EudraLex, perhaps it has not been considered previously to generate such a present book. The author noticed a lack of resources in the EU GMP checklist & GAP analysis material for the pharmaceutical industry in member states. The first seed of inspiration was growing slowly while the draft book started almost a year before publication, and the context has become tailored afterward in many directions.