How to Comply with ANVISA’s RDC 658/22: Good Manufacturing Practices, LIMS, and the Path to Compliance

If you work in the pharmaceutical industry, you know that maintaining compliance with regulations from the Brazilian Health Regulatory Agency (ANVISA), such as RDC 658/22, is not just a requirement — it’s a commitment to safety, quality, and market trust.

With the publication of Collegiate Board Resolution (RDC) No. 658, of March 30, 2022, which sets out the guidelines for Good Manufacturing Practices for Medicines (GMP) in Brazil, this commitment takes on new dimensions. The regulation demands more robust processes, rigorous data control, and a solid quality system from the beginning to the end of the production chain.

However, how can you ensure all these requirements are met efficiently, without overburdening operations?

To answer that question, in this article we show how technology — particularly the use of a Laboratory Information Management System (LIMS) — can be the foundation for meeting RDC 658/22 strategically. And at the end, we point you to a free short course to deepen your knowledge of the regulation.

What Is ANVISA’s RDC 658/22 and How Does It Affect Pharmaceutical Manufacturing?

RDC 658/22, issued by ANVISA, establishes the requirements for ensuring quality and safety in pharmaceutical manufacturing in Brazil. The regulation aims to ensure that medicines produced follow quality standards aligned with the international guidelines of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), a major international scheme aimed at harmonizing pharmaceutical inspection practices.

In this way, minimum requirements are established for pharmaceutical manufacturing, and, in addition, the competitiveness of the domestic pharmaceutical industry is strengthened through the quality assurance of the medicines made available to the public.

From investigational medicinal products used in clinical trials to commercialized products, RDC 658/22 applies to every company involved in any stage of pharmaceutical manufacturing.

With RDC 658/22, compliance is no longer an optional goal — it is now a regulatory obligation.

The Challenge of RDC 658/22 Compliance: How to Maintain Full Control Over So Many Requirements?

Implementing RDC 658/22 requires meeting numerous requirements, such as Risk Management and Supplier Qualification. To comply with Good Manufacturing Practices (GMP), every stage of production must be documented, controlled, and auditable.

However, when these processes are managed through spreadsheets, paper records, or fragmented systems, significant risks emerge. Without real-time integration and traceability, there is a greater chance of errors, data loss, and failures in critical workflow compliance — compromising both product quality and regulatory compliance.

Furthermore, Risk Management can become incomplete without a structured system to identify, classify, and monitor risks throughout the production cycle. Likewise, Supplier Qualification can fail if it does not ensure consistent evaluation criteria, performance history, or up-to-date documentation, which weakens the supply chain and can directly impact the safety and efficacy of medicines.

How LIMS Optimizes Compliance with RDC 658/22 and Good Manufacturing Practices

A LIMS is key to ensuring the laboratory meets RDC 658/22 requirements. Automating and integrating steps such as data traceability and efficient risk and supplier management becomes far easier with the support of a robust system like a LIMS, since it is an effective way to ensure compliance, control, and confidence throughout the entire production process.

By centralizing data and integrating the laboratory’s different areas, a LIMS not only facilitates audits and inspections but also reduces operational errors, improves efficiency, and ensures that all regulatory requirements are properly met.

With Actiz LIMS, for example, you automate and digitize the entire sample journey — from intake in the laboratory to the final result — creating a controlled, secure, and 100% traceable quality environment.

Want to Master RDC 658/22? Take the Short Course with Experts

Understanding the regulation’s requirements is essential, but knowing how to apply them in practice is what makes the difference. With that in mind, in partnership with Biochemie and ER Analítica, we created the online short course “RDC 658/22 — Good Manufacturing Practices for Medicines,” featuring 4 hours of practical, certified content.

You’ll learn from:

– Ingrid Ferreira Costa – CEO of Biochemie, auditor and ISO standards specialist.
– Hadassah Rocha – Postgraduate in Forensic Sciences and Quality Management.
– Renato Rainho – Director of ER Analítica, specialist in calibration and equipment control.
– Felippe Domingos – Co-founder of Actiz and a leading LIMS reference in Latin America.

The short course on ANVISA’s RDC 658/22 offers pharmaceutical industry professionals a complete opportunity to deepen their knowledge of Good Manufacturing Practices for Medicines (GMP). With 365 days of access, the content can be revisited whenever needed, supporting continuous, flexible learning.

The course syllabus covers the main points required by the regulation, including:

1. Introduction to Good Manufacturing Practices (GMP)

2. Pharmaceutical Quality Management System (PQMS)

3. Personnel and Training Requirements

4. Documentation and Records

5. Control of Raw Materials and Packaging

6. Production and Process Control

7. Complaints, Recalls, and Self-Inspection

8. Regulatory Aspects and Oversight

Access the free short course now and boost your RDC 658 compliance

Actiz LIMS: The LIMS Platform for Laboratories That Want More Efficiency and Autonomy

Actiz operates across numerous segments throughout Latin America, supporting companies in laboratory digitalization and compliance with the highest regulatory standards. With Actiz LIMS, you ensure compliance, traceability, and operational excellence, from raw material intake to the final medicine batch.

Don’t leave compliance for later. Transform your processes with the support of a robust, reliable LIMS.

Talk to our experts and discover how Actiz LIMS can transform quality management at your company