What ANVISA measures in a CBPF audit?

The Certificate of Good Manufacturing Practices (CBPF) is a formal document issued by ANVISA that certifies that an establishment complies with all quality and safety requirements in its production processes. Contrary to what many believe, possession of the certificate is not mandatory for the basic operation of the company. However, it functions as a seal of quality that opens doors. Having the CBPF is practically indispensable for participating in bids, closing contracts with large retail chains, and, above all, for exporting products. It is valid for two years for the standard process, counted from the date of publication in the Federal Official Gazette. For foreign manufacturers who wish to sell in Brazil, obtaining the CBPF is a fundamental step for the release of their product registration.

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ANVISA's audit is holistic and covers all departments that directly or indirectly impact the quality of the final product. Focusing on just one area is a common mistake that leads to rejection. Auditors evaluate, without exception:

• Quality Control and Quality Assurance: The existence and effectiveness of a quality assurance system is the foundation of the entire operation. Auditors verify that procedures are strictly followed, that control records are complete and traceable, and that there is a robust program for validating methods and processes.
• Facilities and Utilities (Water, Compressed Air, and HVAC): The physical infrastructure is thoroughly inspected. This includes proper design to prevent cross-contamination, cleaning and predictive maintenance of production and storage areas, and qualification of critical systems such as purified water, compressed air, and HVAC systems that control temperature, humidity, and differential pressure.
• Production and Process Control: Here, the focus is on adherence to Standard Operating Procedures (SOPs). Auditors observe whether manufacturing steps are clearly defined, whether equipment is calibrated and validated, and whether real-time control of critical process steps is performed and documented.
• Storage and Inventory Management: The warehouse receives special attention. The assessment covers the storage conditions of raw materials and finished products (such as temperature and humidity control), batch traceability, expiration date management, and effective segregation of approved, rejected, and quarantined materials.

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At the end of the inspection, ANVISA issues a report with one of three possible classifications, each with direct implications for deadlines and business health:

• Satisfactory: This is the ideal result. It means that the company meets Good Practice requirements and the ANVISA Good Practice certificate will be issued, granting the company a passport of credibility for two years.
• Under Review: This classification indicates that non-conformities were found, but considered to be of low criticality. The company has a maximum of 120 days to implement the requested corrective actions and prove their effectiveness to ANVISA. Failure to meet this deadline results in automatic rejection of the certificate.
• Unsatisfactory: The most critical scenario, applied when the audit identifies serious flaws that compromise the quality and safety of the products. Immediate consequences may include interruption of imports (for foreign companies), suspension of activities, or even recall of products from the market. In this case, a new process can only be initiated after the flaws have been completely corrected and a new petition has been filed.

Many companies are unaware that there is more than one way to obtain certification, which can represent significant savings in time and resources. For manufacturers of Risk Class III and IV medical devices, for example, ANVISA accepts alternatives to direct on-site inspection:

• On-site Inspection by ANVISA: The traditional route, where agency auditors conduct the inspection directly at the factory.
• Documentation Assessment and Risk Analysis: A process that may dispense with physical inspection based on analysis of the submitted documentation.

MDSAP (Medical Device Single Audit Program) Report: A strategic and agile option. Manufacturers that have a valid MDSAP audit—a program recognized by regulatory agencies in several countries, including ANVISA—can use it to obtain CBPF. The great advantage of this route is that the certificate can be issued with a validity of four years, twice the validity of the conventional process, significantly speeding up entry and maintenance in the market.

Transforming ANVISA's complex regulatory framework into a competitive advantage requires more than technical knowledge; it demands strategic vision and practical experience. It is in this context that Stone Okamont establishes itself as the ideal partner for companies that cannot afford failures, delays, or bans.

With Stone Okamont, your company will not only be preparing for an audit; it will be building a solid foundation of operational excellence, protecting its market, and accelerating its growth. Contact us for an initial diagnostic assessment and find out how we can turn regulatory compliance into your greatest competitive advantage.