Checklist: Is Your Company Ready for RDC 982/2025?

RDC 982/2025 introduced a new model for sanitary risk management and continuous compliance monitoring, directly impacting companies involved in the manufacturing, distribution, and storage of active pharmaceutical ingredients, medicines, biological products, medical devices, and even cannabis for medical purposes. To support your organization, we have prepared a practical and reliable checklist that helps you determine whether your operation is compliant with the regulation’s requirements and ready for audits. In this material, you will find:

• The 17 objective criteria defined by RDC 982/2025 for compliance assessment;

• Clear items to indicate whether your company is “Compliant” or “Non-Compliant”;

• Guidance to assess risks of losing, renewing, or canceling certificates (CBPF and CBPDA);

• A structure organized by distinct areas of the regulation, making audits easier;

• Additional fields to record responsible staff, audited unit, and review dates.

With this checklist, your team gains a clear, fast, and reliable roadmap to reduce regulatory risks, anticipate non-compliances, and ensure greater security in inspections — turning compliance into a competitive advantage for your business.