Brazil REBLAS / EQFAR Certification

For laboratories involved in pharmaceutical and health-related testing in Brazil, obtaining REBLAS or EQFAR certification is crucial for credibility, compliance, and market access. These certifications, issued under the authority of Brazil’s health regulatory agency (ANVISA), ensure that laboratories meet the required technical and quality standards for conducting analytical testing on regulated products such as medicines, APIs, cosmetics, food, and others.

What Are REBLAS and EQFAR Certifications?

  • REBLAS (Rede Brasileira de Laboratórios Analíticos em Saúde) refers to the national accreditation for analytical laboratories authorized to perform testing on regulated products, including pharmaceutical and cosmetic goods, under ANVISA oversight.
  • EQFAR (Equivalência Farmacêutica) certification is granted to laboratories authorized to conduct pharmaceutical equivalence studies — particularly relevant for generic drug registration.

Both certifications ensure that laboratories have the technical capability, quality systems, and regulatory approval to generate valid analytical results for regulatory use.

Who Needs REBLAS or EQFAR?

REBLAS certification is mandatory for any third-party laboratory that provides testing services for companies in the regulated health sector. This includes labs offering services to pharmaceutical companies, cosmetic manufacturers, or importers.

EQFAR certification is particularly important for laboratories that:

  • Conduct dissolution or comparative analytical studies for bioequivalence and generic submissions.
  • Support pharmaceutical equivalence submissions required by ANVISA.

In-house QC labs used only for internal purposes typically do not require REBLAS certification, unless their services are offered externally.

Key Requirements for Certification

To qualify for REBLAS or EQFAR status, laboratories must meet a series of technical, legal, and quality-related criteria:

  1. Legal and Administrative Requirements
    • Be legally registered and operating within Brazil.
    • Have a qualified Technical Responsible (RT) — a licensed professional legally authorized to oversee laboratory operations.
    • Maintain appropriate business and sanitary licenses.
  1. Laboratory Infrastructure
    • Adequate physical layout and facilities that support safe, controlled analytical testing.
    • Proper segregation of work areas to avoid contamination.
    • Equipment must be appropriate for the analytical methods proposed, validated, and regularly maintained.
  1. Quality Management System (QMS)
    • Implementation of a formal QMS based on Good Laboratory Practices (GLP).
    • Availability of standard operating procedures (SOPs), training records, equipment logs, deviation management, and CAPA (Corrective and Preventive Actions) systems.
    • For EQFAR, specific procedures for comparative dissolution studies and analytical validation are required.
  1. Personnel Competence
    • Laboratory staff must be trained and qualified in the analytical techniques used.
    • Continued training programs and performance monitoring should be in place.
  1. Documentation and Traceability
    • Complete documentation of all analyses performed.
    • Full traceability of raw data, sample handling, results, and approvals.
    • Data integrity controls and backup systems should be in place.

Step-by-Step Certification Process

Step 1: Internal Preparation

Evaluate the current laboratory setup, infrastructure, staffing, and quality systems. Address any gaps and align operations with REBLAS or EQFAR requirements.

Step 2: Application Submission

Prepare a formal application to ANVISA, including:

  • Legal documentation
  • Scope of testing
  • Evidence of QMS implementation
  • Proof of technical capabilities and personnel qualifications

EQFAR applicants also need to demonstrate experience and validation in comparative pharmaceutical analysis.

Step 3: ANVISA Review

ANVISA will analyze the application, verify documentation, and evaluate scope compatibility. If needed, additional documents or clarifications may be requested.

Step 4: On-Site Inspection

A regulatory inspection may be scheduled to assess the actual compliance of the facility. Inspectors will verify laboratory practices, QMS execution, data integrity, and scope-specific procedures.

Step 5: Certification and Publication

Once approved, the certification is granted for a period of four years, and the lab is officially listed as a certified REBLAS or EQFAR facility. The certification is published by ANVISA for public access.

Step 6: Renewal and Scope Changes

Renewal petitions must be submitted at least 3 months before the certificate expires. Laboratories can also request expansion of scope (e.g., adding new types of tests) through supplementary filings.

Benefits of REBLAS and EQFAR Certification

  • Regulatory Recognition: Validates that the lab meets ANVISA’s quality and technical standards.
  • Market Access: Enables labs to provide services for product registration and post-market control.
  • Trust and Credibility: Enhances reputation and competitive positioning in the contract lab market.
  • Eligibility for Government Contracts: Certified labs may qualify for contracts with public health programs.

How Masuu Pharma Quality and Regulatory Consultants Can Help

Navigating the REBLAS and EQFAR certification process can be time-consuming and technically demanding. Masuu Pharma provides comprehensive support at every stage:

  • Gap Analysis: We perform a full diagnostic review of your lab’s current capabilities, quality systems, and documentation — highlighting gaps and proposing corrective actions.
  • Quality System Development: We help design or optimize your QMS, including SOPs, training plans, deviation logs, and audit systems — all tailored to REBLAS/EQFAR standards.
  • Application Preparation: Our experts prepare all necessary documents and assemble a submission-ready application to ANVISA, ensuring accuracy and completeness.
  • Inspection Readiness: We conduct mock audits, train your team, and provide on-site or virtual support during regulatory inspections.
  • Ongoing Support: From scope expansion and renewal submissions to QMS maintenance and staff retraining, we stay with you for the long term.
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