Learn how internal audits in the pharmaceutical industry ensure product quality, safety, effectiveness and regulatory compliance.

Internal audits play a key role in ensuring the compliance and efficiency of a company’s operations. In the pharmaceutical industry, this practice is extremely important, as it involves verifying the manufacturing, storage and distribution of pharmaceutical products.

The pharmaceutical industry is governed by a number of national and international regulations and standards. Internal audits, or auto-inspections, in this area assess whether the company’s procedures and activities comply with the regulations and good practices established by health authorities.

Thus, the objectives of internal audits in the pharmaceutical industry are to identify and correct potential non-conformities, improve the quality of products and processes and avoid potential risks and problems. However, it is important to highlight that this process requires detailed planning and a systematic approach.

To carry out an effective internal audit in this area, it is necessary to follow some essential steps that we highlight below:

Step 1 – Planning

 The first step in carrying out an internal audit in the pharmaceutical industry is to clearly establish the objectives and scope of the audit. This involves identifying the specific processes and areas to be assessed and which specific standards apply.

With the objectives clearly established, it is important to develop a detailed plan for the internal audit. This includes determining the team responsible for conducting the audit, defining the audit techniques and tools to be used, and establishing a schedule for activities.

It is important to note that internal audits in the pharmaceutical industry should be conducted by competent and impartial auditors who have in-depth technical knowledge of sector-specific regulations and guidelines.

Step 2 – Assess regulatory compliance

 Once the plan is defined, the next step is to conduct the audit itself, conducting interviews, reviewing documents and records, assessing whether good manufacturing practices are being followed and whether all safety and quality requirements are being met, verifying processes and comparing what is carried out with what is established in regulatory standards.

Collecting information is essential for obtaining an overview of processes, identifying potential problems and obtaining evidence of compliance. During this process, it is essential to maintain an impartial and objective approach, prioritizing obtaining accurate and reliable information. It is also essential to document all non-conformities identified and make recommendations to correct any problems detected.

Step 3 – Monitoring and review

 After completing the audit, it is necessary to monitor and verify the effectiveness of the corrective actions implemented to resolve any non-conformities found. Moreover, it is important to periodically review the internal audit program, ensuring that it is up to date and includes any regulatory or operational changes in the pharmaceutical industry.

Finally, it is worth highlighting that internal audits in the pharmaceutical industry should not be seen as a purely bureaucratic obligation, but as an essential practice to ensure the safety and quality of products and services provided to the public, as well as ensuring compliance with regulations. This way, companies in the pharmaceutical industry can guarantee the safety and effectiveness of their products, protecting the health and well-being of consumers.

Step 4 – Automate the audit process

Automating the internal audit management process provides a number of advantages. First, automation allows pharmaceutical companies to standardize audit procedures in a consistent manner, ensuring that all relevant items are evaluated in accordance with applicable standards and regulations. Additionally, automation can analyze large volumes of data quickly and accurately, drastically reducing the time needed to complete an audit.

Automation enables real-time reporting, providing a comprehensive, up-to-date view of compliance. This real-time monitoring capability is particularly important for the pharmaceutical sector, where any deviation from compliance can have serious consequences.

Step 5 – Reports and recommendations

 Based on the data collected and the assessment of regulatory compliance, it is important to identify areas for improvement in the company. This may include processes that fall below established standards, issues with documentation, or a lack of employee training.

After collecting and analyzing the data, it is necessary to issue an audit report containing the findings and recommendations. Thus, it is important to prepare a detailed report, including findings, identified compliance gaps, and recommendations for improvement. This report should be clear, objective and based on concrete evidence, aimed at helping the company implement the necessary corrections to improve its performance.

Do you have difficulties managing audits in your company?

Are you lost among the many papers, checklists and spreadsheets?

Carrying out an audit using old methods can be stressful, right? To make the entire audit process easier, learn more about SoftExpert Audit.

SoftExpert Audit is the definitive tool to simplify all your audits, including internal, operational, IT, supplier, risk and quality audits.

  • Automate the entire audit process, from planning, preparation, schedules, and creating plans and checklists to execution, recording findings, reporting and monitoring.
  • Plan your audit using templates or personalized forms according to your audit objectives, scope, criteria and methods.
  • Carry out your audits from anywhere and at any time using mobile devices. The system also allows you to download audit checklists to work offline.
  • Manage auditor profiles, skills and schedules, ensuring correct auditor assignments to meet audit scope and requirements.
  • Manage audit findings, documents and evidence in one place and record non-conformities and corrective actions directly from the findings.
  • Reduce time and effort when performing audits with automatic task assignments, shifts, alerts and email notifications.
  • Generate customized reports and dashboards with relevant metrics to monitor internal audit performance, identify areas of non-compliance and support management decision-making.

Ensure regulatory compliance and improve your management system with SoftExpert Audit.

Learn more

Daiane Loeffler


Daiane Loeffler

Daiane Loeffler é Analista de Produto e Mercado da SoftExpert. Engenheira Química, formada pela UNISOCIESC, especialista em Engenharia de Processos pela Sustentare Escola de Negócios e especialista em Engenharia Farmacêutica pelo Instituto Racine. Possui experiência na área de Processos e Sistema da Qualidade, com conhecimentos em Boas Práticas de Fabricação, Gerenciamento de Riscos, Auditorias, Análise de causa raiz, CAPA, FMEA, PPAP, APQP e Six Sigma.

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