Certification of Good Practice

What is it?

The Certificate of Good Manufacturing Practices (CBPF) is the document issued by ANVISA to certify that the business complies with the current legislation guidelines for the manufacture of a given product. It’s issued to prove that the company has been instructed and inspected during the manufacturing process.

The Certification of Good Manufacturing Practices, in addition to being a requirement, is one of the most improved parameters in the world, attesting that the business complies with Good Manufacturing Practices. The risk classification products level III and IV need, necessarily, the Certificate of Good Manufacturing Practices with ANVISA.

Failure to implement Good Practices will result in the petition being rejected by ANVISA. Therefore, it’s very important to hire an advisory with authority in the field to avoid adversities.

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Common
QUESTIONS

Is Certificate of Good Manufacturing Practices (CBPF) mandatory for a company to function?

No. Only companies that produce products subjected to Sanitary Surveillance and with risk classification level III or IV, must obtain the Certificate of Good Manufacturing Practices.

Which establishments need CBPF by ANVISA?

Companies that manufacture (CBPF), import or export (CBPI), store or transport (CBPD) products of risk classification level III or IV.

Harmonization of the Quality System for Certificate
of Good Manufacturing Practices (CBPF) at ANVISA

Despite the high volume of companies that present the Quality System in place, many are not in compliance with ANVISA's current terms.

After making the systems compatible, Stone Okamont will develop an execution plan to point everything your company needs, improving and instructing you how to proceed to obtain the Certificate of Good Manufacturing Practices at ANVISA.

Stone Okamont conducts national and international audits harmonizing the Quality System for the Certificate of Good Manufacturing Practices (CBPF) request.

Implementation of the Quality System for Certification of Good Practices for Companies

In the case of companies that only need the implementation of the Quality System, Stone Okamont will provide all the advice and consultancy necessary to realize this. With an initial analysis, we will identify the necessary actions to proceed in a dynamic and assertive way, leveraging the implementation and maintenance of the system on the long term.

How can we help you?

We operate in an exclusive way, adjusting, elaborating and implementing all the necessary procedures for the implementation of the quality system according to each client needs.

We have specialized professionals in all areas, making it possible to appoint an expert with adequate knowledge for your field of activity so that the process flows smoothly and avoids rework.