Good Manufacturing Practices

Publicado em 29/10/2020 15h48 Atualizado em 23/09/2025 14h27

Applicable regulations

Alignment with PIC/S Guidelines

As a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Anvisa adopts internationally recognized standards to ensure the quality and consistency of Good Manufacturing Practices (GMP). The Agency’s regulations are harmonized with the PIC/S Guide to Good Practices for the Manufacture of Medicinal Products, including its annexes, which provide specific guidance for different types of products and processes.

Anvisa’s main regulations and their corresponding international references include:

Anvisa Regulation	International Reference (PIC/S)
RDC 658/2022 – General GMP Guidelines for Medicines	Guide – Part I
RDC 654/2022 – GMP for Pharmaceutical Inputs	Guide – Part II
IN 35/2019 – Sterile Medicines	Annex 1
IN 127/2022 – Biological Inputs and Medicines	Annex 2
IN 128/2022 – Radiopharmaceuticals	Annex 3
IN 129/2022 – Medicinal Gases	Annex 6
IN 130/2022 – Phytotherapeutic Medicines	Annex 7
IN 131/2022 – Sampling of Raw Materials and Packaging	Annex 8
IN 132/2022 – Liquids, Creams and Ointments	Annex 9
IN 133/2022 – Pressurized Dose Aerosol Medicines	Annex 10
IN 134/2022 – Computerized Systems	Annex 11
IN 135/2022 – Ionizing Radiation in Manufacturing	Annex 12
IN 136/2022 – Experimental Medicines	Annex 13
IN 137/2022 – Blood Derivative Medicines	Annex 14
IN 138/2022 – Qualification and Validation	Annex 15
RDC 636/2022 – Parametric Release	Annex 17
IN 139/2022 – Reference and Retention Samples	Annex 19

All the regulations mentioned above can be consulted in full through Anvisa’s official legislation portal: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=apresentacao&cod_menu=9434&cod_modulo=310#/visualizar/479680.

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);
Resolution RDC 850/2024 - Amends the Resolution of the Collegiate Board - RDC No. 497 of 2021 to extend the validity of the Good Manufacturing Practices Certification of medical device manufacturers granted through the MDSAP Program to four years.
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.

Food

Resolution RDC 275/2002 (Technical Standard Operating Regulation Procedures applicable to Food Producing Companies and the Checklist for GMP);
Resolution RDC 7/2000 (Certificate of Good Manufacturing Practices and control for the purposes of authorizing the export of canned palm heart to Brazil);
Resolution RDC 352/2002 (Good Manufacturing Practices for establishments producing/processing preserved fruits and/or vegetables);
Resolution RDC 172/2003 (Good Manufacturing Practices for establishments that manufacture processed peanuts and derivatives)
Resolution 267/2003 (Good Manufacturing Practices for Edible Ice Cream Manufacturing Establishments);
Resolution RDC 28/2000 (Good Manufacturing Practices in establishments processing salt intended for human consumption);
Normative Instruction IN 82/2000 (Good Manufacturing Practices for Dietary Formulas for Inborn Errors of Metabolism).
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).

Personal Hygiene Products, Cosmetics and Fragrances

Resolution RDC 48/2013.

Sanitizers

Resolution RDC 47/2013.

GMP Certification

MEDICINAL PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS, INCLUDING BIOLOGICALS

The Good Manufacturing Practices (GMP) Certificate is an official document issued by Anvisa that attests a manufacturing facility’s compliance with the applicable GMP standards required for the commercialization of regulated products in Brazil.

Although holding a GMP Certificate is not mandatory for regular operation, compliance with GMP standards is required at all times for all manufacturers of regulated products.

To support decisions on GMP certification, Anvisa may rely on different regulatory tools, including:

Inspection reports issued by Anvisa or by local health authorities (state, district, or municipal);
Inspection reports and documentation from Equivalent Foreign Regulatory Authorities, in accordance with Instruction Normative (IN) 292/2024, which establishes the use of regulatory reliance mechanisms.

The procedures for GMP Certification are detailed in Resolution RDC 497/2021, which defines the administrative process for granting certificates for Drug Products (Medicines), Medical Devices, Personal Hygiene Products, Cosmetics and Fragrances, Sanitizers, Food, and Active Pharmaceutical Ingredients (APIs).

GMP Certificates issued by Anvisa are valid for two years from the date of their publication in the Brazilian Official Gazette (Diário Oficial da União).

To consult current GMP Certificates: https://consultas.anvisa.gov.br/#/

All the regulations mentioned above can be consulted in full through Anvisa’s official legislation portal: https://anvisalegis.datalegis.net/action/ActionDatalegis.php? acao=apresentacao&cod_menu=9434&cod_modulo=310#/visualizar/479680.

MEDICAL DEVICES

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 and four years from MDSAP analysis.

INTERNATIONAL INSPECTIONS TO VERIFY GOOD MANUFACTURING PRACTICES

Anvisa carries out international inspections to verify GMP compliance in foreign companies that manufacture Drug Products (Medicines) and Active Pharmaceutical Ingredients (APIs) intended for the Brazilian market. A valid GMP Certificate is a prerequisite for granting marketing authorization in Brazil for these products.

The Brazilian legal representative of the foreign manufacturer is responsible for requesting GMP Certificate renewals every two years. Depending on a risk analysis, Anvisa may decide:

To conduct a new on-site inspection, or
To issue a certificate based solely on a documentary assessment and the available evidence from reliable sources.

Important: Foreign companies cannot contact directly with Anvisa for GMP Certification procedures. They must have a partner company legally established in Brazil, which will act as the local representative and assume legal responsibility for the imported products.