RAGB

As stated in RDC 25/09, the companies below must request ANVISA an inspection for Certification of Good Practices and control. The companies that do not meet this standard will not be able to record the processes of products registration of these classes anymore. The certificate turned into a compulsory item on the checklist of documents for registration and revalidation of registration of:<br />
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• Manufacturers of equipment and materials for health fitted in the following risk classes, III and IV;<br />
• Manufacturers of all products of diagnosis in vitro fitted in the following risk classes, II, III and IV;<br />
• Manufacturers of products from the registration exemption list in the risk classes I and II of the IN no 07/09<br />
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RABG has a technical team skilled to implant and or adjust your quality system, our auditors are capable of carrying out a pre-inspection, orientation and training so that your team obtain the Certification of Manufacturing and or Distribution Good Practices.<br />
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Companies that need the BPF Certification – Manufacturing Good Practices and BPD – Distribution Good Practices – in compliance with the ANVISA standards can count on RAGB to implant or adjust your quality system. Out work method consists of a pre-audit that highlights all important points of improvement and non-conformities and develops an actions plan so that the company becomes able to receive BPF and BPD Certifications required by the Health Legislation in force. The service also includes professional follow-up during ANVISA inspection.<br />
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O nosso método de trabalho consiste em pré-auditoria que levanta todos os pontos importantes de melhorias e não conformidades e desenvolve um plano de ações para que a empresa esteja apta a receber a Certificação BPF e BPD exigida pela Legislação Sanitária Vigente. O serviço ainda inclui acompanhamento profissional durante a inspeção da ANVISA.<br />
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“The process of consultancy enables custom solutions for each customer, through the following steps:<br />
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Initial Diagnosis<br />
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The quality system of the organization is evaluated in relation to the specified standard requirements, where information is obtained for the elaboration of an action plan.<br />
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Planning<br />
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The actions plan includes all the necessary steps for an effective implementation of the quality management system, as well as the organization of the work groups<br />
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Initial Capacitation<br />
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The training embraces courses according to the needs identifies in the organization, whereas they’re technical or behavioral.<br />
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Management system Documentation<br />
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The documental system is designed and elaborated with our support, according to the organization needs, including the manual of Manufacturing and or Distribution Good Practices, procedures, work instructions, logs, forms, etc.<br />
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Implantation<br />
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We seek for the involvement of the whole quality and productive team aiming at a long-term sustainability and maintenance of the system.<br />
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Final Evaluation of the quality system before the certification <br />
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A full analysis of the quality system is executed in relation to the standard adopted. A report containing non-conformities and recommendations for correction and final evaluation of the quality system implanted for the certification is issued.<br />
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RAGB’s consultancy service in Quality enables custom solutions for each customer.