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.

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Opdateret den: 29-07-2026 17:44