Consultancy in ANVISA GMP and BPD Certification

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:

• Manufacturers of equipment and materials for health fitted in the following risk classes, III and IV;

• Manufacturers of all products of diagnosis in vitro fitted in the following risk classes, II, III and IV;

• Manufacturers of products from the registration exemption list in the risk classes I and II of the IN no 07/09

Companies that need the BPF Certification – Manufacturing Good Practices and BPD – Distribution Good Practices – in compliance with the ANVISA standards can count on Amaral & Cia 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.

Our working method is to pre-audit raises all the important points of improvement and nonconformities and develops an action plan for the company is able to receive the GMP certification and BPD required by the Health Law Ruling. The service also includes professional support during the inspection of ANVISA.

“The process of consultancy enables custom solutions for each customer, through the following steps:

Initial Diagnosis

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.

Planning

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

Initial Capacitation

The training embraces courses according to the needs identifies in the organization, whereas they’re technical or behavioral.

Management system Documentation

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.

Implantation

We seek for the involvement of the whole quality and productive team aiming at a long-term sustainability and maintenance of the system.

Final Evaluation of the quality system before the certification

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.

Please contact us for more information on all of our Brazil consulting services...