欧洲GMP药品现场检查项目表.docVIP

Audit Checklist for Drug Industry Disclaimer The following checklist is intended to aid in the systematic GMP audit of a facility that manufactures drug components or finished products. The adequacy of any procedures is subject to the interpretation of the auditor. Therefore, the author accepts no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist. Instructions for Using this Audit Checklist: Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem areas and items, if any, that were ide