FDA Audit Checklist – Preparing for an FDA Auditor Visit

In order to meet US Food and Drug Administration (FDA) requirements, medical device manufacturers active in the US market must undergo FDA audits of their quality management systems to demonstrate compliance with Quality System Regulation 21 CFR Part 820, also known as Good Manufacturing Practice (GMP).

As a manufacturer, developer or contract manufacturer, you must conduct an FDA GMP audit of your quality system to ensure product quality, identify and make process improvements and address any existing or potential regulatory compliance problems.

To prepare for an FDA audit of your quality system, you can develop your own internal audit checklist to evaluate how well you currently comply with FDA GMP requirements and make any necessary adjustments—ahead of a visit by an actual FDA auditor.

An internal GMP audit checklist can include various components, depending on where you believe your strengths and weaknesses lie in terms of quality system compliance.

Full or partial GMP audits

Internal GMP audits are required by the FDA, focusing either on your quality system as a whole or on particular areas of your process where noncompliance may be an issue; in instances where conflicts of interest may occur, you can enlist third-party auditing service providers to fulfill this requirement.

Gap analysis audits

Gap analysis audits are conducted to establish your current level of FDA GMP compliance and identify potential deficiencies.

Supplier audits

Audits of your critical suppliers is also required as part of your FDA GMP internal audit; even if you use subcontractors for some or all of your medical device manufacturing process, you must verify that those providers meet your requirements in terms of appropriate standards and regulations.

FDA pre-inspection audits

FDA pre-inspection audits are similar to gap analysis audits, but focus more on areas an FDA auditor tends to examine most thoroughly—corrective actions, complaint handling, special process and manufacturing processes.

FDA GMP mock audits

Finally, FDA GMP mock audits are designed to closely mimic actual FDA audits, and can best prepare you for dealing with real FDA inspections.

The Quality System Regulation spells out some specific rules that must be followed when conducting your own internal quality audit:

• Audits must be conducted by personnel who do not have direct responsibility for the processes being audited
• Corrective actions such as re-auditing of deficiencies must be conducted when necessary
• Results of quality audits as well as any necessary re-auditing must be prepared and reviewed by managers responsible for the processes subject to the audit
• Dates and results of quality audits and re-audits must be documented

Please contact us for more information on preparing an FDA audit checklist.