Considerations in GMP Auditing

The following is a quick list of things to do as an auditor. Using this list will help you to make sure that you are on track as you plan and conduct GMP audits.

Maintain and Use a Written SOP for GMP Auditing

Establishing a written audit procedure will help to ensure that all audits are conducted in a consistent manner, and that they meet the minimum requirements. The audit procedure is your roadmap to a successful audit. Some information you could include in an audit procedure might be the frequency of audits, the systems to checked, whether audits are announced or unannounced, and who should be included on the audit team.

Assure Confidentiality of Outcomes

Assuring the confidentiality of the outcomes of the audit and audit reports is extremely important as an auditor fosters a good relationship with the people you will be auditing. Make sure that they know that you are not trying to embarrass them, or to catch them doing something wrong. Remind them that the purpose of your audit is to check systems to make sure that there are no lapses in quality, and that the results will not be used in a way that publicly targets individuals. In most cases, even the FDA will not be able to look at internal audit results.

Use Checklists As Needed

On the auditing page of this site, the GMP Institute provides some auditing checklists. Customize and use these as a guide to your auditing as needed. Read the article Using Checklists in GMP Auditing to help you learn how to do this most effectively.

Make Sure That All Auditors Have Proper Qualifications

GMP regulations require that employees be properly qualified (through proper training, education, and experience, or a combination thereof) to do their jobs. It should therefore be documented that auditors are able to properly conduct their duties.

Eliminate Any Conflicts of Interest

Integrity is one of the most important characteristics of a good auditor, and maintaining integrity necessitates eliminating any conflicts of interest you may have. The most common conflict of interest to arise for an internal auditor is when he or she has responsibility for an area being audited. External or supplier auditors can face other types of conflicts of interest, including having a family member or friend who works for the company, owning a significant amount of stock in the company, or having previously worked there. If you find yourself in one of these positions, or facing another type of conflict of interest, you must disclose it to management, and in most cases decline to participate in the audit.

Address Scheduling Issues

When considering when to schedule audits, make sure that you do a GMP audit at least once a year. Also, you will have to decide whether to do an announced or an unannounced audit. Unannounced audits are more common.

Assume a Cooperative and Non-Confrontational Manner While Auditing

The role of an internal GMP auditor is to assist the company by ensuring that all proper quality and GMP specifications are being properly met. Therefore, work to establish a good working relationship with those you audit. You really should be working with your auditees to protect your customers, to make sure that everyone gets to keep their job, and that the company remains profitable and respected. Do not approach an audit as an opportunity to catch someone messing up, or to embarrass them. Everyone in the company should have the same goals - making products that are safe, pure, and effective. Acting in a cooperative and non-confrontational manner will help you to achieve these goals.

Make Sure That Your Audit Report Is Completed In a Timely Manner

For some auditors, drafting the audit report is the least favorite part of the job. It is time consuming, and it can seem like there is always something more urgent to which you must attend. However, auditors who don't complete audit reports in a timely manner may jeopardize their own professionalism. The sooner you can put the results of an audit on paper, the fresher it will be in your mind. Therefore it is more likely to be accurate if it is done right away. Also, it is important to get the feedback to the people who are affected by the findings as quickly as possible. If the audit findings are presented right away, while it is still fresh in their minds, they will be more likely to take needed corrective action in a timely manner.

In The Audit Report, Make Sure That Your Observations Are Fair, Balanced, and Use Non-inflammatory Language

The purpose of an audit is to make your company better at what it does, not to offend fellow co-workers. While sometimes it may be impossible to adequately do the job of an auditor and not offend anyone, you should certainly try to minimize negative feelings and confrontations without compromising the integrity of your work. Making sure that your observations on the audit report are fair, balanced, and don't use unnecessarily inflammatory language will help you to gain the trust of those being audited.

Plan Corrective Actions and Re-audits, If Necessary

The last step of an audit is to participate in the planning of corrective action, the time frame in which it will occur, and to schedule a re-audit of deficient areas. This will ensure that improvement results from the findings of the audit.