Auditing is an essential practice to ensure regulatory compliance and product quality in the pharmaceutical industry. A well-prepared audit report is key for documenting the observations and deficiencies identified during the audit, as well as proposing an effective and targeted action plan to correct and prevent future problems.
Audit reports and action plans in the pharmaceutical industry must follow a clear and comprehensive structure, providing a detailed overview of the areas assessed and identifying opportunities for improvement.
How to prepare an effective audit report and action plan in the pharmaceutical industry
1. Data collection and organzation
Before you start to prepare the audit report, it is critical to collect all relevant data during the audit process. This includes the results of previous audits, records of non-conformities, relevant regulatory documentation, company policies and procedures, among others. Organizing this data in a clear and categorized way is imperative to facilitate the report writing process.
2. Clarity and objectivity
The audit report must be clear and objective, transmitting information clearly and concisely. Avoid unnecessary technical jargon and use accessible language to ensure all stakeholders can understand the report. Furthermore, the report must be structured logically, following a coherent order that allows for easy reading and understanding.
3. Identification of non-conformities
During the audit, it is important to identify all non-conformities that were found, according to the established audit criteria. Moreover, it is necessary to clearly describe the specific issues discovered, providing details on the areas affected and implications for the quality and compliance of pharmaceutical products. Using objective evidence, such as records, photographs, or interviews, helps to support the conclusions presented in the report.
Conduct a risk analysis of identified non-conformities, assessing the probability of occurrence and the impact on the business. Prioritize these risks according to their severity and urgency.
4. Prepare audit recommendations
After identifying the non-conformities, it is necessary to develop an effective action plan to correct and prevent deviations, as well as to improve the audited processes. The action plan must be clear, detailed, and results oriented. It must include the activities to be performed, individual responsibilities, execution deadlines, and completion criteria. Also, the action plan must be realistic and feasible, taking into account the company’s available resources and constraints.
The action plan must contain the following elements:
- Action: description of the activity to be performed to correct or prevent the deviation;
- Responsible: name or position of the person or team responsible for conducting the action;
- Deadline: planned or actual date for starting and ending the action;
- Status: current status of the action, which can be planned, in progress, completed or cancelled;
- Evidence: the document or record that proves the action was performed.
Close the report with a conclusion that summarizes the key points covered. Summarize the audit results and emphasize the importance of implementing the recommendations to improve the efficiency and compliance of the audited organization.
Include any relevant documents that may support the report’s conclusions and recommendations, such as evidence of non-conformities, applicable regulations and standards, among others.
5. Present the audit report to the auditees and responsible managers
The fifth step is to present the audit report to the auditees and responsible managers, in a clear, objective, impartial and evidence-based manner.
6. Assess effectiveness of implemented actions
A constructive audit report does not end with the presentation of the action plan. It is critical to regularly monitor and review the implementation of the action plan to ensure that corrective measures are being effective, and that compliance is being maintained.
Therefore, monitor the implementation of recommendations, checking whether the auditees developed and executed an adequate and effective action plan to meet the recommendations, assessing the effectiveness of the implemented actions, checking whether deviations were corrected or prevented and whether the processes were improved.
Assessment can be done through:
- Documentary verification: consists of analyzing documents or records that demonstrate the actions performed by the audited unit;
- On-site verification: consists of visiting the facilities or places where the actions were performed by the audited unit;
- Sampling verification: consists of selecting a part of the documents, records, facilities, or locations that represent the totality of the actions performed by the audited unit.
Progress reports should be prepared regularly to document progress and make adjustments to the action plan if necessary. The report must include the following elements:
- Audit identification: with the title, type, period and location of the original audit;
- Monitoring identification: with the type, period and location of the monitoring conducted;
- Monitoring results: with a description of the results upon verifying the recommendations and actions implemented by the audited unit.
Meet SoftExpert Audit
Preparing an effective audit report and action plan in the pharmaceutical industry requires attention to detail, clarity in communication, and a commitment to compliance and product quality. By following the tips above, pharmaceutical companies can develop effective reports and action plans, contributing to the continuous improvement of processes and ensuring the safety of pharmaceutical products.
However, we know that managing audits in the pharmaceutical industry can be a complex, time-consuming and bureaucratic process, which requires a large volume of documents, forms, records, reviews, and approvals. But SoftExpert Audit can streamline and speed up this process.
SoftExpert Audit is a solution that enables automating, organizing, and controlling audit processes efficiently and securely. You can use it to:
- Plan, execute, and assess audits based on applicable standards and regulations;
- Identify, record, and classify audit non-conformities easily and accurately;
- Prepare, monitor, and evaluate recommendations and actions quickly and effectively;
- Generate audit action plans and reports with clarity, objectivity, and impartiality;
- Store, access, and protect audit information securely and confidentially.
