How do you prioritize GMP audits and inspections with a busy schedule?

1 Assess the audit scope and frequency

The first step to prioritize GMP audits and inspections is to determine the scope and frequency of each audit or inspection based on the regulatory requirements, the risk level, and the performance history of the audited or inspected entity. For example, you may need to audit or inspect a critical supplier more often than a low-risk one, or a new facility more frequently than an established one. You can use a risk-based approach to rank the audit or inspection subjects according to their potential impact on product quality, patient safety, and business continuity.

2 Schedule the audit or inspection activities

The next step is to schedule the audit or inspection activities in advance, taking into account the availability of resources, the deadlines, and the contingencies. You should communicate with the audited or inspected entity to confirm the dates, the objectives, the agenda, and the expectations of the audit or inspection. You should also coordinate with your team members, your management, and your stakeholders to ensure alignment and support. You should avoid scheduling conflicts, overlaps, or gaps that could compromise the quality or efficiency of the audit or inspection.

3 Prepare the audit or inspection plan and checklist

The third step is to prepare the audit or inspection plan and checklist based on the scope and objectives of the audit or inspection. You should review the relevant documents, records, and data of the audited or inspected entity to identify the areas of focus, the criteria, and the evidence. You should also develop a list of questions, observations, and findings that you will use during the audit or inspection. You should ensure that your audit or inspection plan and checklist are clear, comprehensive, and consistent with the GMP standards and guidelines.

4 Conduct the audit or inspection

The fourth step is to conduct the audit or inspection according to the plan and checklist. You should follow the audit or inspection agenda and respect the time and resources of the audited or inspected entity. You should collect and document sufficient and reliable evidence to support your conclusions and recommendations. You should also communicate effectively and professionally with the audited or inspected entity, your team members, and your stakeholders. You should address any issues, deviations, or non-conformities that arise during the audit or inspection promptly and appropriately.

5 Report the audit or inspection results

The fifth step is to report the audit or inspection results in a timely and accurate manner. You should analyze and evaluate the evidence, the observations, and the findings of the audit or inspection to determine the compliance status, the risk level, and the improvement opportunities of the audited or inspected entity. You should also prepare a clear, concise, and objective audit or inspection report that summarizes the scope, objectives, methods, results, conclusions, and recommendations of the audit or inspection. You should share the report with the audited or inspected entity, your management, and your stakeholders.

6 Follow up on the audit or inspection actions

The sixth step is to follow up on the audit or inspection actions to ensure that they are implemented effectively and verified satisfactorily. You should monitor and track the progress, the status, and the outcomes of the corrective and preventive actions (CAPAs) that are agreed upon with the audited or inspected entity. You should also verify that the CAPAs are adequate, complete, and sustainable to address the root causes and prevent recurrence of the issues, deviations, or non-conformities. You should provide feedback and recognition to the audited or inspected entity, your team members, and your stakeholders.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?