Redator Kivalita em 19 de January de 2024 em Articles

All about the new API Guide No. 71/2024 in Brazil

Anvisa’s guide No. 71/2024, which deals with the continuous production of APIs (active pharmaceutical ingredients), has just been released on January 11, 2024, bringing many relevant scientific and regulatory aspects for those who want to sell inputs in Brazil, taking into account good management and development of the production life cycle.

In recent years, after the health crisis generated by Covid-19 that promoted a great movement in the market, with the exhaustion of APIs previously exported from countries such as China and India, Brazil has experienced a significant growth in the number of domestic suppliers. The Ministry of Health “expects to produce 70% of the demand for various health products in Brazil in 10 years” and brings a good outlook for the year 2024, as disclosed at the Active Pharmaceutical Ingredients seminar held by ABIFIQUI (Brazilian Association of the Pharmaceutical Ingredients Industry) in December 2023.

The guide launched on the 11th applies to chemical entities and therapeutic proteins, in addition to covering new products, and biological and biotechnological entities.

The document provides the following definition: “Continuous Production involves the continuous feeding of input materials, the continuous transformation of materials in processing, and the concomitant removal of processed materials from the manufacturing process.

The guide provided is based on some ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guides, starting from the Q7 guide, on Good Manufacturing Practices for APIs, to Q12, which brings regulatory considerations for the management of the life cycle of pharmaceutical products. The ICH, according to ANVISA, “…is the world’s leading forum for the harmonization of technical requirements, composed of regulatory authorities and the pharmaceutical industry.” The main topics covered in Guide No. 71/2024 are:

  1. Control State
  2. Process dynamics
  3. Materials characterization and control
  4. Equipment design and system integration
  5. Process monitoring and control
  6. Traceability and segregation of materials
  7. Process Modeling

Continuous improvement

When discussing some scientific approaches, Guide 71/2024 talks about how Continuous Production provides the application of the philosophies of Continuous Improvement, called here as Control Strategy. According to this philosophy, a holistic approach to CP, ICH guidelines, risk management principles and some current legislation, favors the development of a Control Strategy. For this, it is necessary to consider aspects such as:

  1. Input Material Attributes
  2. Process monitoring and control
  3. System Operation
  4. Segregation and collection of materials
  5. RTRT
  6. Integration of equipment and systems

All these attributes need to be detailed and documented in the continuous production dossiers, in order to ensure the control of the product produced and thus enable the application of performance indicators.

The Guide to Continuous Production of Active Pharmaceutical Ingredients is a document with mostly technical language, with broad definitions of how the API production system should be and how to document it. Examples of dossiers and technical diagrams can be found in the annexes. It is important to emphasize that this is not a normative document, but a guideline one, and it is up to the companies to choose whether or not to follow the instructions described therein, provided that the implications in the current health regulations are observed.

Kivalita Consulting has extremely qualified professionals, with the necessary expertise to help your company achieve this regulatory compliance, with a team specialized in the pharmaceutical sector, ensuring autonomy and speed. Talk to us today about your demands!

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