Establishing a written audit process will help ensure that all audits are conducted in a consistent manner and meet minimum requirements. An audit procedure is your roadmap for a successful audit. Some information that may be included in the audit procedure may be the frequency of checks, the systems being checked, whether the audit is announced or not, and who should be included in the audit team.
Ensuring the confidentiality of audit results and audit reports is extremely important as the auditor maintains good relationships with the people he will audit. Make sure they know that you are not trying to embarrass them or realize that they are doing something wrong. Remind them that the purpose of their audit is to review the systems to ensure that quality does not deteriorate and that the results are not used in a publicly people-oriented manner. In most cases, even the FDA will not be able to see the results of the internal audit.

Use Checklists as Needed:

Checklist- The checklist is a popular tool to help the cGMP auditor conduct a thorough, systematic and consistent audit. It is important that any list of questions, whether in checkmark format or open questions, be answered by comments and used as a tool, not the entire audit.
However, the checklist should not replace proper planning before the start of the audit. Consider the benefits of using a well-prepared checklist. This ensures that the auditor will ask most of the critical questions necessary to comply with the cGMP requirements, and if properly prepared, it will help the auditor focus on important issues and not be absorbed in small details.
The questions on the prepared list may be more objective than those asked by the auditor, including an experienced auditor. Prepared questions indicate to those whose departments or functions are being audited that the auditor is ready to conduct a systematic audit.

Resolving Schedules Audits:

When considering when to plan your audits, be sure to conduct a GMP audit at least once a year. In addition, you will have to decide whether to perform an announced audit or not. Unannounced reviews are more common.

Make sure your audit report is timely completed:

The sooner you can present the audit results on paper, the fresher they will be on your mind. Thus, it is more likely to be accurate if done immediately. In addition, it is important to get feedback from people affected by the results as soon as possible. If the audit results are presented immediately, although they are still fresh in their thoughts, they are more likely to take the necessary corrective actions in a timely manner.

Corrective action planning and new audits, if necessary:

The last stage of the audit is to participate in the planning of corrective actions, the time frame in which they will be carried out and the planning of a new audit of the defective areas. This will provide better results based on the audit results.

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