ANVISA has recently published RDC No. 972/2025, bringing significant changes for regulated companies, especially regarding online control during product packaging. These updates directly impact compliance with RDC No. 658/2022 and require immediate attention from industries to remain compliant.
What does the new RDC No. 972/2025 say?
The main change is in Article 372 of RDC No. 658/2022, which now allows companies to dispense with the implementation of online control during packaging, as long as they present a robust technical justification and adopt other adequate control strategies based on quality risk management. In addition, paragraphs (§1 and §2) of Article 372—which established mandatory deadlines and strict steps for implementing online control—have been revoked.
New text of Article 372:
“The implementation of online control set forth in Article 215 may be waived when there is a technical justification for doing so, provided that the company adopts other adequate control strategies based on quality risk management.”
What has changed in practice?
Previously:
RDC No. 658/2022 required companies to strictly follow deadlines for the implementation of online control at the packaging stage, including proof of execution for steps such as URS (User Requirement Specification), manufacturer selection, design qualification, purchase, installation, and operation.
Now:
With RDC No. 972/2025, companies gain flexibility: it is no longer mandatory to follow this rigid timeline, as long as there is a valid technical justification and alternative control measures are adopted based on risk management.
What is the impact for companies?
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More flexibility: It is now possible to dispense with online control, provided there is a robust technical justification.
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Greater responsibility: The requirement for strong risk management increases. Companies must carefully document their justifications and the alternative controls adopted.
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Procedure updates: Internal procedures must be reviewed, documentation updated, and teams trained for the new requirements.
Kivalita Consulting Recommendations
Given these changes, it is essential to:
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Review and update your quality risk management in packaging processes;
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Ensure that all technical justifications are well documented and aligned with the new guidelines;
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Update SOPs and train staff on new routines;
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Stay alert to further publications and interpretations from ANVISA.
Count on Kivalita to guide you through regulatory changes!
Kivalita Consulting has a specialized team ready to help your company interpret and implement the new regulatory requirements, from diagnosis to execution of all necessary adjustments.
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