![]() Enter details in your notebook and cross reference your comments with the questions. ![]() Although a single question may be included about any requirement, the answer will usually be a multi-part one since the auditor should determine the audit trail for several products that may use many different components.While the checklist is to guide the auditor, is not intended to be a substitute for knowledge of the GMP regulations.The checklist is to be used with a notebook into which detailed entries can be made during the audit.What does your "customer", i.e., your superior or senior facility management, expect to learn from this audit? If you are not already familiar with this facility, learn the type of product produced here and how it is organized by personnel and function. Review past audits, note indications of possible problem areas and items, if any, that were identified for corrective action in a previous audit. Instructions for Using Audit Checklistīefore starting an on-site audit, plan the audit. ![]() Therefore, ISPE and the GMP Institute accept no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist. The adequacy of any procedures is subject to the interpretation of the auditor. This GMP audit checklist is intended to aid in the systematic audit of a facility that manufactures drug components or finished products.
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