Internal audits – sometimes also called self inspections – are a crucial part of every Quality Management System. Sometimes they are perceived as a regulatory necessity only to comply with the Good Manufacturing Practices. However, it can be of very high value to your organisation if executed correctly.

Understanding audits

In the evolving landscape of pharmaceuticals, where the integrity of products directly impacts global health, maintaining unparalleled standards of quality, safety, and compliance is not just a goal – it’s a mandate. Amidst the complexities and challenges inherent in pharmaceutical manufacturing, one essential practice stands out as a beacon of assurance: audits.

At its core, an audit is a meticulous examination and evaluation of all facets of pharmaceutical operations. It involves scrutinizing processes, facilities, documentation, and systems to ensure adherence to regulatory requirements, industry standards, and internal protocols. From production facilities to supply chain management, every aspect of pharmaceutica

Advantages of internal audits

Quality Assurance & Regulatory compliance

The industry operates within a tightly regulated framework governed by stringent regulations enforced by regulatory bodies such as the FDA, EMA, and others globally. Compliance with these regulations is not just a legal obligation but a moral imperative to ensure the safety and efficacy of products.

Internal audits contribute to maintaining and improving the quality of pharmaceutical products. Regular audits help companies identify gaps in compliance and implement corrective measures to align with regulatory standards, mitigating the risk of non-compliance and potential repercussions. By systematically reviewing processes and systems, auditors can identify areas for improvement, helping organizations adhere to high-quality standards and reduce the risk of defects or deviations.

Risk mitigation

The supply chain is inherently complex, encompassing multiple stakeholders and interconnected processes. Audits help identify potential risks, vulnerabilities, and opportunities for improvement across the supply chain—from sourcing raw materials to distributing finished products. By proactively identifying and addressing risks such as counterfeit drugs, contamination, and supply chain disruptions, audits enhance risk management strategies, ensuring product integrity and patient safety.

Operational efficiency

Internal audits evaluate the effectiveness of operational processes and can identify areas for optimization. By streamlining workflows and improving efficiency, organizations can reduce costs and enhance productivity, contributing to overall operational excellence.

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

Preparedness for external audits

Regular internal audits help organizations stay prepared for external audits conducted by regulatory authorities or clients. When organizations have a robust internal audit program in place, external audits are more likely to proceed smoothly, with fewer surprises or findings. It also helps departments understand what is expected of them and promote a quality culture.

Execution of an internal audit

Selection of the auditor

An auditor should have sufficient knowledge of the audited processes as well as auditing experience. This can come from previously joining internal audits with a more experienced lead auditor or from experience in external audits.

An auditor should be ethical, open-minded, observant, and objective. Objectivity can be a problem when people know each other, especially in smaller organisations. It can help using an external party, since they are not part of the workings of the organisation it will give an unbiased and objective perspective.

Preparation

An audit should be carefully prepared, this should result in an agenda and a checklist or audit flow. It determines which documents, proof, and activities an auditor wishes to see. Useful documents to prepare for an audit are the audit program, guidelines, SOP’s, risk assessments, targets, KPI’s, previous audit reports etc.

Checklist or no checklist?

A checklist can be useful for starting auditors as a tool to not forget any parts. It is a systematic and efficient way of working. However, using a checklist reduces freedom and flexibility and can be viewed as less favorable for experienced auditors. The biggest pitfall for checklists is that it can result in false answers if the questions are known by the auditees when the same checklist is used multiple times.

Auditing without checklist will lead to a spontaneous conversation and can be more stimulating for an experienced auditor. Although, it requires more skill from the auditor to get complete answers and not deviate from the topics at hand.

During the audit

Every audit starts with an opening meeting where introductions take place, and where the agenda and scope are aligned between all parties.

The goal of an internal audit is not to find faults, it is to understand the audited process and to find proof that it is compliant. An audit should follow a logic flow (e.g. sample flow within a laboratory). Proof such as SOP’s, logbooks, deviants, etc. should be asked where necessary.

An audit is concluded with a closing meeting. During the closing meeting an auditor should make sure that the conclusions are understood by the auditees as this is the beginning of the solution. When an audited department can understand the observations, the necessary actions will be implemented easier.

Report

Every audit should be recorded, normally a report is written with all the observations per category (critical, major, minor, recommendation). When working in a team, all the members should take the time to go over the observations and prepare conclusions. If required, additional investigation should be conducted. The report should be written according to SOP or template in the organization. The report should be concise, complete and an accurate display of the audit. But most importantly, it should be written constructively.

Conclusion

Audits are indispensable tools for ensuring the highest standards of quality, safety, and compliance in the pharmaceutical industry. By embracing a proactive approach to auditing, companies can uphold their commitment to excellence, mitigate risks, and safeguard public health. In an era where the integrity of products is paramount, audits serve as guardians of trust, ensuring that every medication that reaches the hands of patients is of uncompromising quality and efficacy.

Stay tuned for an in-depth view of an experienced lead auditor in our next blog post!

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