Good Manufacturing Practices


Applicable regulations

Good Manufacturing Practices, as a regulatory requirement from Anvisa, apply to companies that manufacture Drugs, Medical Devices, Personal Hygiene Products , Cosmetics and Fragrances, Sanitizing Products, Food and Active Pharmaceutical Ingredients (APIs), located either on national territory or abroad.

The applicable regulation varies in accordance with the type of product manufactured:

Drugs

Resolution RDC 17/2010

Radiopharmaceuticals

Resolution RDC 63/2009

Herbal products

Resolution RDC 13/2013

Medicinal Gases

Resolution RDC 69/2008

Active Pharmaceutical Ingredients

Resolution RDC 69/2014 (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

Sanitizing Products

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 16/2013 (general aspects). Other minimal requirements for certain medical devices’ groups are in Resolution RDC 4/2011 (minimum identification and quality requirements for single use transfusion materials, infusion sets for gravity feed and for infusions using infusion pumps); Resolution RDC 3/2011(minimum identification and quality requirements for sterile hypodermic single-use syringes); Resolution MS/ANVISA 9/1999 (GMP guidelines for blood bags); Resolution RDC 35/2014 (rules for plastic bags for collection, storage and transfer of human blood and its components); and Resolution RDC 55/2011 (minimum identification and quality requirements for surgical gloves and for non-surgical natural rubber, synthetic rubber, blended natural and synthetic rubbers and polyvinyl chloride gloves, under health regulation). Specific Norms and Standards from ABNT (Brazilian Association of Technical Standards) 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 attesting that a particular establishment complies with Good Manufacturing Practices. The certificate is issued (per drug line or per address in case of medical devices) covering production lines, pharmaceutical forms, acquisition procedures (in case of active pharmaceutical ingredients), special therapeutic classes and/or health risk product classes for which the company has been inspected.

The regulation that describes the procedures for obtaining GMP certification by Anvisa is Resolution RDC 39/2013, as amended by Resolution RDC 15/2014 and by Resolution RDC 179/2017. These Resolutions aim at establishing the administrative procedures for granting GMP Certification for Drugs, Medical Devices, Personal Hygiene Products , Cosmetics and Fragrances, Sanitizing Products, and Pharmaceutical Ingredients. Also, Resolution RDC 183/2017 describes further the administrative processes applicable for granting GMP Certification for Medical Devices for manufacturers located abroad.

GMP certificates are valid for two years from the date of their publication in the Brazilian Official Gazette.

 


International inspections to verify Good Manufacturing Practices

Anvisa conducts international inspections to verify Good Manufacturing Practices in companies that manufacture Drugs, 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, international inspections apply only to companies that manufacture products of Risk Classes III and IV. For synthetic API, international inspections are applicable in companies that manufacture active pharmaceutical ingredients listed in Norm IN 15/2009 and IN 03/2013. For biological API, international inspections are applicable to companies that manufacture these APIs that are to be directly imported or that are part of the composition of any drugs that are to be imported by Brazil.

The Brazilian representative of the foreign applicant company must request the GMP certificate renewal every two years. However, 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 palm heart industries located abroad, as a GMP Certificate is required in order to export their products to Brazil.

The schedule of international inspections carried out by Anvisa is publicly avaibale at:

- Drugs: http://portal.anvisa.gov.br/cronograma-de-inspecoes-medicamentos

- Medical Devices: http://portal.anvisa.gov.br/inspecoes-internacionais

- API: http://portal.anvisa.gov.br/cronograma-de-inspecoes-insumos

 

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.

 


Resolution RDC 183/2017 – GMP for manufacturers of Medical Devices

Resolution RDC 183/2017 describes administrative processes applicable for granting GMP Certification for manufacturers of Medical Devices (Risk Classes III and IV) located outside the Brazilian territory and outside Mercosur countries.

This Resolution establishes that in-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, after document assessment:

  • Upon presentation of a valid audit report, issued by a third party auditing organization, in accordance with specific programs, both recognized by Anvisa;
  • Using confidential information on inspections, received under Agreements or Covenants with health authorities of other countries;
  • By assessing inspection or audit report issued by the health authority of an IMDRF member country, or by a third party auditing organization recognized by the health authority;
  • By assessing an audit report issued by a third party auditing organization recognized by Anvisa;
  • By making a risk analysis to assess the need for in loco inspection before granting the Good Manufacturing Practices Certificate, in the case of petitions not referred to or which do not comply with the necessary requirements established for the previous situations.