Who Will Audit?

There are typically four factors used to determine who will audit.

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Auditee Behavior

Sometimes the politics of auditee behavior can be quite amusing. Auditees telling you everything they think you want to hear can be humorous at times. Likewise auditees that absolutely refuse to cooperate can also seem strange.

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On Time GMP Audits

It is time once again for the GMP Audit. An API Audit? An Excipient Audit? A Primary Packaging Material Audit? Who knows?

Everything is ready. The auditees have been duly notified, and anxiously await your arrival. You have taken the time to prepare, studying the requirements and procedures. Read more

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.  Read more

Documentation Review Process in GMP Audits

When conducting an audit, the auditor should first assess the company documentation against the related reference documents. Any findings would then be against company documentation or the quality management system. Then the auditor should match employee actions and records (performance) against what is stated in their own internal documentation. Any findings noted would be against performance of actions as required.

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GXP Audits and Time Management

Time Management

Time is beyond all doubt the GXP Auditor’s worst enemy! Many GXP Auditors find themselves running behind the Audit schedule on just about every audit. GXP Audits are often not a thorough as they should be, which tends to diminish their effectiveness.
So, how do we manage this thing called time? The first step is to “audit the audit”.

That is, to debrief the GXP Audit process. If time (or lack thereof) has affected the audit, determine why time became a constraint. Here are some typical time mismanagement elements.

The three biggest causes of GXP Auditor time constraints are:

  • Lack of preparation
  • Out-of-Scope Issues
  • “Friendly” chatting

In order to avoid this kind of obstacles feel free to get in touch with Regula Inspection Services immediately.