Steps in Auditing API Facilities

Author: Max Lazar
The early steps in auditing Active Pharmaceutical Ingredients (AP) Facilities are to have a clear understanding of ICH Q7, to decide whether you will use or not use a checklist. Here are the guidelines to be followed if you select to use a checklist: Follow Q7 from start to finish, Make it simple to use during audit, identify what is compliant and what is deficient and what needs follow-up.
1. Perform the Audit
Start the audit with an opening meeting comprising introductions, presentations or discussions by auditor and firm, scope of the audit, answers to any questions raised by either party during the original request for scheduling. Request what facilities and systems you will want to examine, discuss what documents and records may be requested during the audit, and ask to start on site review.
2. Examine Records
The records to be examined include both internal and external complaints, failures or special dispositions of lots including documentation, causes, corrective actions applied and checking effectiveness. Other records to be examined include failure rates, APR for product being audited, site’s FDA experience, and appropriate corrective action plan and compliance.
3. Closing the Audit
The things to be kept in mind before closing the audit is to review findings to assure all Q7 issues have been covered, list any missing information, meet with site personnel who can answer and provide the missing information or documents. While closing discuss observations and findings, separate API GMP deviations from company requested items, separate suggestions from requirements and provide timelines for expected corrections.
4. After Audit Requirement
The major steps to be taken after completion of an audit are to identify how you intend to follow up the audit findings, explain what you deem critical, and identify what would be considered major and minor, identify how any findings will impact any existing quality agreements, purchasing agreement, and any regulatory agreements or filings that apply.
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