Also known as Blauimuno, immunoglobulins are normal antibodies and constituents of human blood and protect us from infections. Immunoglobulin is used to increase antibody levels in the blood when the level of it is too low or if necessary additional antibodies in case of diseases.
Plasma-derived immunoglobulin from donors is used to treat a number of disorders, such as primary immunodeficiency syndromes, severe combined immunodeficiency syndrome, and variable common immunodeficiency. Administration of these antibodies may also have an effect in cases of compromised immune system.
Immunoglobulin has a number of immunosuppressive and anti-inflammatory properties providing antibodies against a wide range ofpathogens.
Immunoglobulin testing serves to investigate the levels of antibodies and antigens produced by the immune system with the function of defending our body from bacteria, toxins or viruses.
To register Immunoglobulin with ANVISA, there are several normative instructions, rules and steps that must be followed with ANVISA. if dealing with bureaucracy is complicated for you to contact Stone Okamont, we do all the work for you from start to finish. No rework and unnecessary expenses.
See what are the steps required to register Immunoglobulin in ANVISA.
Before register Immunoglobulin with ANVISA, the first step is to obtain the Operating License for your establishment. It is acquired from a survey conducted by VISA, the Local Sanitary Surveillance.
Stone Okamont works with excellence in the preparation of the Operating License process with VISA.
The Operating License is an approval document with the local Sanitary Surveillance, recognizing that your establishment has technical and operational conditions to carry out your activity and take you to the next step that is the Company Operating Authorization.
The Company Operating Authorization, better known as "AFE" is a document issued by ANVISA, published in the Official Gazette (DOU), it enables you to carry out your activity in which it was petitioned with the Agency. Obtaining AFE means that the company operates in accordance with Brazilian law and is able to operate nationwide, to register Immunoglobulin with ANVISA.
The "AFE" is necessary and indispensable for the next step that is the petitioning of the CBPF, that is, certificate of Good Manufacturing Practices.
The Certificate of Good Manufacturing Practices (CBPF), is the document that attests compliance with the guidelines of the legislation in force for the manufacture of a given product. It is issued to prove that the company has been instructed and inspected during the manufacturing process.
To register Immunoglobulin in ANVISA, assist classification is risk class III, the Certificate of Good Practices is a requirement of ANVISA, which has one of the most improved parameters in the world, attesting that the establishment complies with good manufacturing practices.
The risk classification products III and IV must need the Certificate of Good Practices with ANVISA.
The Product Registration is the document issued by ANVISA legalizing the commercialization of the same. From that moment, to register Immunoglobulin in ANVISA, the agency will analyze the petition in the most appropriate way, checking the documentation presented to certify that the company is in accordance with current legislation and able to develop its activities.
In this final step, product information such as: composition material, instructions for use, disposal instructions, and more are presented. In this way, the petitioning process must be respected, and mandatory documentation must be attached and the petition must be filed with ANVISA.
All companies offering products that may be harmful to health, such as medicines, pesticides, cosmetics, etc.; need to be up to date with all regularizations with ANVISA.
The regulatory affairs sector is responsible for the regularization of products and establishments. We have the role of guidance and technical support in the Regulatory Intelligence service in order to establish the regulatory strategy for the success and competitive advantage of the company.
So, if you need help register Immunoglobulin with ANVISA, talk with those who understand! Count on Stone Okamont, we have a team of professionals trained to meet the needs of your company and product.
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