All posts tagged Audit

According to the FDA guidelines an internal audit should cover the following topics:

FDA CFR Volume I – 4.14 Internal Audits

An internal audit procedure template can be found here:

FDA Audit Procedure Template

An example of an internal audit schedule can be found here:

FDA example of Audit Schedule Template

Before starting the audit you might send an audit questionnaire to the vendor/supplier to gain more information from them before beginning the audit. The link below contains an example questionnaire:

1. Vendor Audit Questionnaire

During the audit you can use a simple checklist to record information. The link below contains an example of a checklist

1. Audit Checklist

Finally once the audit is finished an audit report must be produced. Here are two examples of audit reports:

1. Sample Audit Report

2. EU final audit report template