What to Do in Case of an ANVISA Regulatory Audit?

ANVISA conducts different categories of audits, each with specific focuses:

Scheduled Audits: These are the most common, notified in advance through an official letter. They focus on verifying general compliance with Good Manufacturing Practices (GMP), the accuracy of information in product records, and the adequacy of facilities. The call notice will specify the scope, which can range from a document check to a complete analysis of the industrial plant.

Investigative Audits: Generally unannounced, these are triggered by complaints, product recalls, quality deviations identified in the market, or technical complaints. They are more direct and investigative, and may result in immediate corrective actions and, in serious cases, the precautionary closure of the establishment.

Monitoring Audits: Conducted after a previous audit that identified non-conformities. They aim to verify that the corrective actions promised by the company have been effectively implemented and are effective.

Understanding what type of audit your company is facing is the first step toward adequate and targeted preparation.

I WANT TO PREPARE FOR AUDITS WITH SPECIALISTS

The best strategy for a smooth audit is continuous preparation, not last-minute action. Implementing a robust compliance program is essential. This includes impeccable maintenance of all mandatory documents, such as Operating Permits (AFE), GMP manuals, employee training records, quality controls, and standard operating procedures. Everything should be organized, preferably in an easily accessible digital system, for immediate presentation to auditors.

Conducting regular internal audits and simulations is another valuable practice. They help identify and correct compliance gaps before ANVISA does. Train your team, especially technical managers and guides who will accompany auditors, to understand the process, know where to find information quickly, and respond to questions clearly and transparently, always based on facts and documentary records.

I WANT TO PREPARE WITH EXPERTS

On the day of the inspection, the company's attitude is crucial. Assign a lean and prepared team to accompany the auditors, including the Technical Manager and a representative from senior management. Be transparent and cooperative, providing requested access to areas and documents, but always with a member of your team present to witness all interactions and notes.

During the opening meeting, clarify any questions about the scope. In interviews with employees, ensure that responses are accurate and consistent with documentation. If a deviation is identified, avoid defensive justifications. Instead, demonstrate proactivity in understanding the root cause of the problem and discuss possible immediate corrective actions, showing a genuine commitment to quality and compliance.

At the end of the audit, a closing meeting is held to present the preliminary findings. It is essential to listen carefully, take detailed notes, and clarify any misunderstandings on the spot, if possible. Subsequently, ANVISA will issue a formal Audit Report with the non-conformities identified, categorized by criticality.

The company has a strict deadline, usually 10 to 30 business days, to submit a robust Action Plan. This plan must address each item in the report, detailing the proposed corrective actions, implementation deadlines, and those responsible for each task. The quality of this plan is vital; generic responses or unrealistic deadlines can lead to rejection and penalties. After implementation, it is crucial to monitor the effectiveness of the corrections to ensure that the problem does not recur, closing the cycle of continuous improvement.

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Facing an ANVISA audit does not have to be a lonely challenge. The complexity of the Brazilian regulatory framework demands an ally with practical experience and in-depth technical knowledge, and this is where Stone Okamont stands out as an undisputed strategic partner. Our services are meticulously designed to transform the audit from a stressful event into an opportunity for validation and growth.

With Stone Okamont, you gain more than a consulting firm; you acquire a partner committed to basing your operation on the most solid regulatory compliance possible. Request a strategic assessment and find out how our experts can prepare your company for an audit.