Brazil GMP

Good Manufacturing Practices (GMP) in Brazil are established and overseen by ANVISA, the country’s health regulatory authority. For medicinal products, the current general GMP framework is set out in RDC 658/2022, along with complementary regulations for specific products and manufacturing activities. These requirements cover areas such as quality management, personnel, premises, equipment, production, quality control, documentation, validation, and handling of deviations and complaints.

ANVISA GMP certification is an official certification confirming that a manufacturing establishment complies with the applicable Good Manufacturing Practices requirements established by the Brazilian health authority. The certificate is issued for a specific establishment and regulated activity after the applicable assessment process. GMP certification is relevant to manufacturers involved in regulated products, including medicines and pharmaceutical inputs, depending on the applicable regulatory requirements.

GMP certification requirements depend on the type of product and the activities performed by the company. Manufacturers of medicines and pharmaceutical inputs, for example, are subject to ANVISA’s applicable GMP requirements. Other regulated product categories can have their own specific GMP or good-practice regulations. Companies planning to manufacture or supply regulated products in Brazil should identify the requirements applicable to their product category and manufacturing activities before beginning the certification process.

During a GMP inspection, ANVISA evaluates whether the manufacturing establishment complies with applicable Good Manufacturing Practices. The assessment can cover the quality management system, personnel, facilities, equipment, production operations, quality control, documentation, qualification and validation, storage, complaints, deviations, and corrective and preventive actions. Inspectors focus not only on written procedures but also on whether the systems are properly implemented and consistently followed in day-to-day manufacturing operations.

Brazilian pharmaceutical GMP requirements cover a broad range of manufacturing and quality activities. Important areas include pharmaceutical quality systems, personnel responsibilities and training, premises and equipment, production controls, quality control testing, documentation, qualification and validation, computerized systems, handling of deviations, change control, complaints, product recalls, and quality risk management. Additional requirements may apply depending on the product, such as sterile medicines, biological products, radiopharmaceuticals, or medicinal gases.

An ANVISA GMP certificate for medicinal products is generally valid for two years from its publication in Brazil’s Official Gazette. The certificate relates to the establishment and the activities covered by the certification. Manufacturers should monitor the certificate’s validity and applicable renewal requirements well in advance. Changes to the manufacturing site, activities, or regulatory requirements may also require additional regulatory action depending on the circumstances.

Yes. Overseas manufacturing sites supplying regulated products to Brazil can be subject to ANVISA’s GMP assessment and certification requirements. ANVISA may evaluate foreign manufacturing facilities through applicable regulatory procedures, including international inspections and regulatory reliance mechanisms where permitted. The exact process depends on the product category, manufacturing activity, location of the facility, and applicable Brazilian regulations. Foreign manufacturers should therefore determine the appropriate pathway before submitting their application.

The documentation required depends on the manufacturing activity and product category. It may include information about the manufacturing site, quality management system, personnel, facilities, equipment, production processes, quality control procedures, validation and qualification activities, and other supporting records. A Site Master File or equivalent site information may also be relevant. Because ANVISA requirements vary according to scope, manufacturers should prepare documentation based on the specific certification application rather than using a generic checklist.

A practical way to prepare is to conduct a detailed GMP gap assessment before the inspection. The review should compare actual operations against the current ANVISA requirements applicable to the facility and product. Companies should pay attention to documentation, data integrity, training, equipment qualification, validation, deviations, CAPA, change control, cleaning, production controls, and quality systems. A mock inspection can also help identify weaknesses that may otherwise become findings during the regulatory inspection.

A GMP consultant can support manufacturers by assessing their existing systems against Brazilian requirements, identifying compliance gaps, reviewing procedures and documentation, and helping teams prepare for an ANVISA inspection. Consulting support may also include mock audits, GMP training, CAPA review, quality-system improvements, validation support, and inspection readiness. The consultant provides technical and regulatory assistance, while GMP certification itself remains the responsibility of ANVISA.