Brazil pushing pharmaceutical manufacturing GMP compliance

Jun 12, 2023
By Paulo Machado
Post também disponível em português

With directive RDC-658 from March 30, 2022, Brazil established the guidelines mandating formal “Good Manufacturing Practices”—more commonly referred to as GMP—for the pharmaceutical industry. This directive has a very far reach in creating medicines for distribution in the country. 

Good Manufacturing Practices for pharmaceuticals are guidelines and regulations that ensure the quality, safety and efficacy of pharmaceutical products. These practices are designed to establish a systematic approach to manufacturing processes, documentation and quality control to minimize the risks associated with the production and distribution of pharmaceuticals. 

GMP requires a comprehensive quality management system encompassing the entire manufacturing process, from sourcing to the distribution of finished products. All processes are documented and validated at each step, from raw materials, production, quality control, packaging and storage. 

Of particular importance are the items related to packaging and labeling in the Brazilian rule. Article 215 states: The online control of the product during packaging must include, at least, the verification of the following items: 

I – General appearance of packages. 

II – Whether the packages are complete. 

III – Whether correct products and packaging materials were used. 

IV – If impressions applied during the packaging process are correct. 

V – Correct operation of line monitors. 

These requirements essentially mandate manufacturers to have automated line vision and inspection solutions to be able to comply with this section of Brazil’s GMP rule. 

With decades of machine vision expertise, Systech solutions combine vision technology with procedural management and device communication to provide our customers with a single solution for real-time production monitoring, control, data collection and reporting – all with GMP compliance in mind. 

  • Packaging accuracy: Verify package labeling, contents, and data on a wide variety of container types. 
  • Data integrity: Confirm printed data is consistently present, readable and contains the correct information. 
  • Quality assurance: Detect packaging defects immediately and correct real time.

Per the Brazilian implementation resolution

I – By October 7, 2020, pharmaceutical companies must have completed the Elaboration of User Requirements (URS) and prospecting for vision equipment manufacturers.  

II – By April 7, 2021, the selection of the vision equipment manufacturer and the Qualification of the Design must have already been completed. 

III – By October 7, 2021, the purchase order should have been sent to the selected vision equipment manufacturer. 

IV – By October 7, 2023, the vision equipment should have been installed. 

V – By October 7, 2024, the other stages of qualification of the vision equipment necessary for the operationalization of art. 215 and its routine start-up. 

However, several pharmaceutical companies are behind schedule and have not selected a vision equipment vendor yet.  To meet these timelines and be compliant with the RDC-658 directive, you need a trusted partner with experience managing thousands of lines running packaging vision and inspection solutions – Systech is that partner. 

Read our standards paper to learn how Systech’s proven configurable model can help you fast track your serialization project.


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