Internal audits

Background

In the rapidly changing landscape of the pharmaceutical industry, where product quality has a direct impact on global health, maintaining standards for quality, safety, and compliance is not just a goal—it is a moral mandate. Amid the complexity and challenges inherent in pharmaceutical manufacturing, one practice stands out as a beacon of assurance: audits.

At its core, an audit is a meticulous evaluation of all facets of pharmaceutical operations. It scrutinizes processes, facilities, documentation, and systems to ensure they comply with regulatory requirements, industry standards, and internal protocols. From manufacturing facilities to supply chain management, every aspect of the pharmaceutical industry

Benefits of Internal Audits

Quality Assurance & Regulatory Compliance

The industry operates within a tightly regulated framework, governed by strict regulations imposed by regulatory agencies such as the FDA, EMA, and other global bodies. Compliance with these regulations is not only a legal obligation but also a moral duty to ensure the safety and efficacy of products.

Internal audits help maintain and improve the quality of pharmaceutical products. Periodic audits help companies identify gaps in compliance and implement corrective actions to meet regulatory standards, thereby reducing the risk of non-compliance and potential repercussions. By systematically reviewing processes, auditors can identify improvements that help organizations achieve high-quality standards and reduce the risk of defects or deviations.

Risk Mitigation

The supply chain is often complex, involving multiple stakeholders and interconnected processes. Audits help identify potential risks, vulnerabilities, and opportunities for improvement throughout the supply chain, from the procurement of raw materials to the distribution of finished products. By proactively identifying and addressing risks—such as counterfeit medicines, contamination, and supply chain disruptions—audits improve risk management strategies and ensure product integrity and patient safety.

Operational Efficiency

Internal audits assess the effectiveness of operational processes and can identify opportunities for optimization. By streamlining processes and improving efficiency, organizations can reduce costs and increase productivity, contributing to overall operational efficiency.

In an industry characterized by innovation and rapid progress, continuous improvement is not only a goal but a necessity for sustainable growth and competitiveness. Audits serve as a catalyst for driving continuous improvement by promoting transparency, accountability, and operational excellence. By analyzing audit findings, implementing best practices, and embracing innovation, pharmaceutical companies can optimize processes, improve efficiency, and adapt to changing regulatory landscapes and market dynamics.

Preparing for External Audits

Conducting regular internal audits helps organizations prepare for external audits by government agencies or clients. When organizations have a robust internal audit program, external audits proceed more smoothly, with fewer surprises or findings. It also helps departments understand what is expected of them and fosters a culture of quality.

Conducting an internal audit

Selecting an auditor

An auditor must have sufficient knowledge of the processes being audited and have audit experience. This can come from previous participation in internal audits with a more experienced lead auditor, or from experience with external audits.

An auditor must be ethical, open-minded, observant, and objective. Objectivity can be an issue if both parties know each other, especially in smaller organizations. It may help to engage an external party; since they are not part of the organization’s operations, they can provide an unbiased and objective perspective.

Preparation

An audit must be carefully prepared. This results in an agenda and a checklist or audit flow. It determines which documents, supporting evidence, and activities an auditor wants to review. Useful documents to prepare include the procedures listed in the audit agenda, risk analyses, KPIs, previous audit reports, and associated CAPA plans.

Checklist or no checklist?

For novice auditors, a checklist can be a useful tool to ensure that no items are overlooked. It is a systematic and efficient way of working. However, using a checklist reduces freedom and flexibility and may be considered less advantageous for experienced auditors. The biggest pitfall of checklists is that they can lead to untruthful answers if the auditee is familiar with the questions when the same checklist is used multiple times.

Auditing without a checklist leads to a spontaneous conversation and can be more stimulating for an experienced auditor. However, it requires greater skill on the part of the auditor to elicit complete answers and stay on track with the agenda items.

During the audit

Every audit begins with an opening meeting that includes a round of introductions, followed by a discussion of the audit agenda and scope.

The purpose of an internal audit is not to find errors, but to understand the audited process and find evidence that it complies. An audit must follow a logical sequence (for example, the flow of a sample within a lab). Evidence such as SOPs, logbooks, nonconformities, etc., should be requested as needed.

An audit concludes with a closing meeting. During the closing meeting, an auditor must ensure that the auditee understands the conclusions, as this is the first step toward a solution. When an audited department can understand the observations, the necessary actions will be easier to implement.

Reporting

Every audit must be documented; typically, a report is written listing all observations by category (critical, major, minor, recommendation). When working as a team, all members must take the time to review the observations and prepare conclusions. If necessary, additional investigation should be conducted. The report must be written in accordance with the organization’s SOP or template. The report should be concise, complete, and an accurate reflection of the audit. But most importantly, it should be written in a constructive manner.

Conclusion

Audits are indispensable tools for ensuring the highest standards of quality, safety, and compliance in the pharmaceutical industry. By taking a proactive approach to audits, companies can maintain their commitment to excellence, mitigate risks, and protect public health. In an era where product integrity is of the utmost importance, audits serve as a means of building trust to ensure that every medication that reaches a patient is of excellent quality and efficacy.

Stay tuned for some detailed insights from an experienced lead auditor in the next blog post!