Bøger om Audit

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.

This book is for both Auditors and Auditee in EU GMP Manufacture of Sterile Medicinal Products. All guideline sections are used as the source for various questions and checklists for evaluating the requirement and identifying the gaps as well, as they can be used for Auditing manufacturing sites. If you are performing an Audit, your job is already done by highlighting requirements and sufficient address to the guideline where you can use the clause number. The Auditee's responsibilities are implementing CAPA based on the observations you will address in the Audit report. But if you are performing Gap Analysis or continual improvement, then the next step would be planning and implementing the required actions by handling Corrective & Preventive Actions. Moreover, a Contamination Control Strategy (CCS) toolbox is a bonus source designed and extracted from the guideline content to inspire manufacturers to establish the CCS in their PQMS system. CCS is a vast live risk assessment. The structure of the required elements for CCS (but not limited to) is used in designing the table to be evaluated for specific concerns.