Find out how QR Group’s internal audits and inspections ensure compliance with RDC 665/2022 and agility in product registration
Focusing on internal audits, QR Group offers Good Manufacturing Practices (GMP) inspections at suppliers, preparing manufacturers to meet ANVISA requirements and ensure compliance in records. In this text, we explain the process and benefits for medical device companies.
What are internal audits and inspections?
Internal audits and inspections involve systematic analysis of supplier facilities and processes. In the case of class III and IV products, ANVISA requires GMP for registration.
Why is this service strategic?
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Cause and effect: GMP compliance prevents lock-ins in registration approval.
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Clarification: Potential failures in the chain can compromise product safety and cause delays.
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Emphasis: QR Group’s pre-audit speeds up approval and reduces rework.
QR Group’s solution
(a) Preparation for inspection
We pre-audit the supplier’s facilities to ensure compliance with RDC 665/2022.
b) Technical diagnosis
We detect gaps in manufacturing, control, traceability, and maintenance processes.
(c) Effective action plan
Proposal for improvements before ANVISA’s official inspection, minimizing risks and speeding up the registration process.
Target audience
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Manufacturers who need to ensure quality and compliance for class III and IV device registration.
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International companies without a local representative, seeking Brazilian homologation.
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Organizations that want to reduce risk and ensure supply chain efficiency.
QR Group masters the internal audit process, ensuring that its suppliers meet GMP standards and are ready for inspection by ANVISA. Contact us to ensure compliance and agility in the approval of your product!
Source: QR Group
