Good Manufacturing Practices
Applicable regulations
All establishments that manufacture products subject to sanitary surveillance must comply with the requirements of Good Manufacturing Practices (GMP), as a regulatory requirement from Anvisa, including Drug Products (Medicines), Medical Devices, Personal Hygiene Products, Cosmetics and Fragrances, Sanitizers, Food and Active Pharmaceutical Ingredients (APIs), located either on national territory or abroad.
Drug Products (Medicines) - Resolution RDC 658/2022 (general aspects) and Normative Instructions associated.
Radiopharmaceuticals - Resolution RDC 658/2022 and Normative Instruction - IN 128/2022.
Medicinal Gases - Resolution RDC 658/2022 and Normative Instruction - IN 129/2022.
Herbal products - Resolution RDC 658/2022 and Normative Instruction - IN 130/2022.
Active Pharmaceutical Ingredients (APIs) - Resolution RDC 654/2022 (GMP) and RDC 204/2006 (Good Distribution and Fractionating Practices for Pharmaceutical Supplies).
Pharmaceutical Excipients - Resolution RDC 34/2015.
Personal Hygiene Products, Cosmetics and Fragrances - Resolution RDC 48/2013.
Sanitizers - Resolution RDC 47/2013.
Food - Resolution RDC 275/2002 (Technical Standard Operating Regulation Procedures applicable to Food Producing Companies and the Checklist for GMP); Ordinance SVS/MS 326/1997 (Hygienic-Sanitary Conditions and GMP for Producers/Food Industrialization Companies); and Ordinance MS 1428/1993 (Technical Rules for Food Sanitary Inspections; Guidelines for Establishing Good Food Services Production and Delivery Practices; Technical Regulations on Quality and Identification Standards for Food Products and Services).
Medical Devices - Resolution RDC 665/2022 (general aspects); Resolution RDC 687/2022 (administrative processes); Other minimal requirements for certain medical devices’ groups are in: Resolution RDC 291/2019 (parametric release and the use of biological indicators to replace the sterility test in medical devices sterilized by ethylene oxide); Specific Norms and Standards from ABNT (Brazilian Association of Technical Standards), ISO (International Organizations for Standardization) or INMETRO (Brazilian Institute of Metrology, Quality and Technology) may also be applicable, depending on specific devices or processes - for example, those applicable to electro medical equipment requirements.
GMP Certification
The GMP Certificate is a document issued by Anvisa to attest that an establishment complies with the technical requirements of GMP needed for commercializing a product, according to the current law.
Although the GMP Certificate is not mandatory for its regular functioning, all establishments that manufacture products subject to sanitary surveillance must comply with the requirements of GMP.
There are many different tools that can be used to support the decision upon the grant of the certificate, being the inspection report one of them, whether it is issued by Anvisa or by a State, District or County Health Surveillance.
The regulation that describes the procedures for obtaining GMP Certification by Anvisa is Resolution RDC 497/2021. This Resolution aims at establishing the administrative procedures for granting GMP Certification for Drugs Products (Medicines), Medical Devices, Personal Hygiene Products, Cosmetics and Fragrances, Sanitizers, Food and Active Pharmaceutical Ingredients (APIs). Also, Resolution RDC 687/2022 describes further the administrative processes applicable for granting GMP Certification for Medical Devices
GMP Certificates are valid for two years from the date of their publication in the Brazilian Official Gazette.
Currently, Drug Products (Medicines), APIs, Personal Hygiene Products, Cosmetics and Fragrances, and Sanitizers GMP Certificate can be consulted on the following links:
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Drug Products (Medicines): Consulting Anvisa - Certificates;
*includes Personal Hygiene Products and Fragrances.
There is a dashboard available that displays information regarding the inspection procedures in order to verify the compliance with GMP and other relevant information. Its main objectives are to provide greater transparency and to facilitate access to the mentioned information; to allow monitoring the facilities; to enable the inspection management of other regulatory agencies abroad; to share information with other regulatory agencies.
International inspections to verify Good Manufacturing Practices
Anvisa conducts international inspections to verify Good Manufacturing Practices in companies that manufacture Drug Products (Medicines), Medical Devices and APIs that are to be imported and marketed in Brazil. A valid GMP Certificate is a requirement for Anvisa to issue a market authorization for these products.
For Medical Devices, inspections apply only to companies that manufacture products of Risk Classes III and IV.
The Brazilian representative of the foreign applicant company must request the GMP Certificate renewal every two years. However, as mentioned before, many different tools can be used to support the decision, and a risk analysis is carried out to decide whether there is the need for a re-inspection or if the certification can be renewed based on documental analysis.
For Food, international inspections are applicable only to canned palm heart industries located abroad, as a GMP Certificate is required in order to export their products to Brazil, as established in the Resolution of the Collegiate Directory – RDC nº 7, January 27th, 2000.
Please note that it is not possible for foreign companies to make administrative arrangements for issuing of certificates directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.
Information regarding the inspection procedures in order to verify the compliance with GMP is available on the dashboard aforementioned.
Resolution RDC 687/2022 – Administrative processes applicable for granting GMP Certification for Medical Devices
In addition of the general rules of Resolution RDC 497/2021, Resolution RDC 687/2022 describes administrative processes applicable for granting GMP Certification for manufacturers of Medical Devices (Risk Classes III and IV) that:
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manufacturing site that produces a finished device in its name or for another company;
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manufacturing site that is responsible for releasing the finished device, related to at least one production stage, except for designing, shipping, sterilization, packing, and labeling stages; and
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manufacturing site of Software as a Medical Device – SaMD.
The packaging considered as a sterile barrier system of products declared as sterile is considered as a production step that can be certified for good manufacturing practices. Also Manufacturing units for in vitro diagnostic medical devices that carry out the steps of impregnation, laminating or cutting of immunochromatography strips are subject to GMP certification.
This Resolution establishes that on-site inspections by Anvisa will continue to happen, after a priority analysis, and that issuing of GMP Certificates may occur through one of the following procedures, after document assessment:
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Upon evaluation of a valid audit report, issued by a third-party auditing organization, in accordance with specific programs, both recognized by Anvisa;
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Upon evaluation of documents presented and conducting a risk analysis that supports the issuance of the Good Manufacturing Practices Certificate;
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Upon evaluation of inspection report issued by Anvisa as result of the carrying out an on-site inspection, motivated by conducting a risk analysis or by the absence of a audit report.