How to Conduct a GMP Audit?

The GMP audit starts with the opening meeting.

During the opening meeting, the audit team is introduced, the audit planned is reviewed, and audit criteria is confirmed. At this time any logistical needs are also addressed such as auditor meeting room, computer access, directions to the site, and so forth. 

While conducting the audit, the auditor must always remember that they are a guest in the company, department, and area of the auditee, and as such must be polite and observant of existing rules of conduct. Audit evidence will be collected during the audit, which the auditor will use to draw conclusions relating to auditee conformance, risks, or opportunities. At the close of each audit day, a summary of the audit findings (negative, positive, or undetermined) is presented to the auditee.

Audit evidence falls into one of four categories: documents, observations, records, and statements.