PharmOut – GMP and Validation Blog

Addressing audit findings: A simple overview

January 6th, 2010

Your company has just been audited, by a regulatory body like the TGA or FDA, a supplier or manufacturer, and they found the “obvious issues”. The company has too many open or unfinished deviations, corrective actions, change controls and customer complaints. You have a list of other observations presented to the company by the auditors. Now the company must act!

There are so many outstanding issues but product must be made and product must still be released to market. The focus to close these issues just does not seem to be there. To state the obvious, the priority has to changed, as the issues won’t fix themselves.

So where do you start!

This IS a COMPANY issue, and it will require a COMPANY solution to remediate the situation. It will take several keys actions to address the issues:

1. Senior management acceptance of the situation and its impact on the business.

2. creation an action plan to address the issues

3. Having a key responsible person to drive, monitor and communicate progress of the action plan. (Project leader)

4. a small focused team, who will allocate a portion of their time to addressing the issues and

5. Starting……….

The key to success is understanding that the benefits are

1. addressing the issues identified by the auditors, therefore regulatory or site compliance

2. grouping of similar issues, so that they can be addressed effectively and efficiently,

3. By addressing the issues you can identify trends, or opportunities that will save, time, money, double handling and create a greater benefit to the company.

The process must be monitored and reported to the key stakeholders on a regular basis. The monitoring will provide the measure of success to the action plan.

There are many companies in similar situations to your own. So don’t feel alone. I have seen and have been involved with companies, in the situation described above. The resolution did not occur over night. It took time, focus, energy, commitment and leadership.

The benefits are obvious. The list is down to a manageable and acceptable level. The system of addressing the issues is more efficient and timely, and people have accepted that they all have some role to play from time to time to support the ongoing maintenance of the systems. Importantly, the auditors (who will be back again), can see that your key systems are back in control.

Entry Filed under: Compliance,GMP