The Resolutions of the Collegiate Board are regulations created by Anvisa (National Health Surveillance Agency) to regulate several areas. In the Health sector, RDC 654 was published in 2022 and brings guidelines that talk about Good Manufacturing Practices for Active Pharmaceutical Ingredients.
Thus, compliance with this RDC is essential for companies seeking to carry out the correct pharmacovigilance of their products. In other words: it exists to ensure that the raw materials used have the quality and safety required by the Brazilian regulatory agency.
What is an RDC
But before discussing Collegiate Board Resolution 645, let’s remember what an RDC is.
All regulatory agencies have their guidelines and standards that aim to regulate the sectors in which they operate. In the case of Brazil, Anvisa has a main focus on the areas of health, education and the environment and it is the one that creates the RDCs.
Most of the Resolutions bring good practices, standards and legislation that need to be respected by companies. The RDCs aim not only to ensure the safety and well-being of those who work in these companies but also to protect the consuming public by reinforcing the quality and effectiveness of the products manufactured by them.
Learn more: Guide to Risk Management in the pharmaceutical sector
What is the purpose of RDC 654/22
In the specific case of RDC 654, Anvisa stipulates what are the good manufacturing practices (GMP) of medicines by specifically analyzing the manufacture of active pharmaceutical ingredients (also known as APIs).
Therefore, this Resolution is related to another, RDC 658. This, in turn, deals with good manufacturing practices (GMP) in general.
See below what RDC 654 says:
“Art. 1 This Resolution establishes the procedures and practices that the manufacturer must apply to ensure that the facilities, methods, processes, systems and controls used for the manufacture of active pharmaceutical ingredients are adequate, to guarantee quality and allow their use in the preparation of pharmaceutical products”.
Therefore, RDC 654 of 2022 does not assess the quality of a drug itself, but actually looks at a previous step: the manufacture of the main raw material used in the manufacture of that drug.
To this end, the Resolution brings a series of good practices and measures that aim to ensure the quality and safety of an API. In this way, Anvisa inspects companies and performs sanitary control of active pharmaceutical ingredients and all activities, tools, machines, and systems involved in this process.
You can learn all the details of RDC 654 by clicking here.
See also: How to choose the best suppliers for the pharmaceutical industry
What are active pharmaceutical ingredients
Active pharmaceutical ingredients can be considered the main “ingredients” in the manufacture of a drug. They are the raw material that gives the product its pharmaceutical properties.
In other words, the active ingredient is what makes a drug work, as it is what generates effects in the body with the objective of diagnosis, cure, treatment or prevention of a disease.
All APIs must be registered with Anvisa, whether they are used in the manufacture of national or imported medicines, in the form of semi-finished or finished products. This obligation was stipulated by another Resolution, RDC 359.
Read more: How to Implement Good Manufacturing Practices
Conclusion
With the creation of RDC 654, Anvisa made it clearer what criteria need to be followed when a company manufactures the APIs that will be used in its medicines. In this way, the agency facilitates compliance and protects the health of the population.
On the other hand, companies need to pay increasing attention to these good manufacturing practices for active pharmaceutical ingredients, not only to avoid fines and legal sanctions but also to safeguard the quality of their products and their reputation in the market.
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