The acronym RDC stands for Collegiate Board Resolution, which is a type of regulatory standard created by the collegiate board of Anvisa (Brazil’s National Health Surveillance Agency). In general, an RDC establishes the rules, guidelines, and procedures that a corporation must follow. The most common resolutions regulate areas such as health, education and the environment.
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What is an RDC?
As the name implies, every RDC needs to be prepared by a collegiate board. This group is responsible for making the decisions that will regulate aspects such as safety, product efficacy, quality of services, and manufacturing processes.
Once prepared, the Resolution of the Collegiate Board must be approved by Anvisa’s Director and then published in the Official Gazette.
Every RDC aims to create an efficient and up-to-date regulatory framework, making it clearer to companies what they need to do to comply with laws and standards related to their area of operation.
Therefore, the RDCs are essential to promote not only the protection of the health of workers and consumers but also the proper functioning of the regulated sectors.
How to adapt to an RDC?
Knowing what RDC is and understanding its importance is not enough if you want to maximize the benefits of these resolutions, as well as ensure compliance with the legislation. It is also necessary to adapt to them and follow their updates.
So, to help you with this task, we have separated a step-by-step guide with tips for you to ensure that your company will always be under the requirements of the Collegiate Board Resolutions related to your area of expertise. Check it out!
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Understand the DRC
First, study the objectives, details, and guidelines present in the DRC. Understand how it applies to your industry or area of expertise, identifying its repercussions and consequences, as well as what it aims to regulate/avoid. This step is essential to align your actions and future expectations.
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Foster communication and transparency
Then, create an open dialogue flow with your colleagues and superiors. Transparency about the changes and how they will impact the company’s performance is essential. This way, you can anticipate bottlenecks, ask questions, share knowledge, and seek clarification when necessary.
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Make sure you and your team have the necessary knowledge
Find out if you and other employees who relate to the RDC have the necessary skills or knowledge to create the demands and actions necessary for the adaptation.
If necessary, attend training, workshops, or courses to stay current. Another golden tip is to use compliance management software to automate tasks and monitor indicators quickly and intuitively.
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Organize activities
Create a plan to incorporate the new DRC guidelines and rules into the daily activities of the operation. Also make an analysis of what is already done, if everything is under the new rules.
To deal with changes in a systematic way, prioritize the areas that require the most attention and will have the strongest relationship with the Resolution.
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Adapt your processes
Armed with the analyses carried out in the previous step, it is time to evaluate and adjust your work processes to comply with the RDC. This can include changes in procedures, documentation, methodologies, tools, and even area organizational charts.
This is the time to get your hands dirty and make changes in practice that will bring the adaptation to the Resolution.
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Document everything
Remember to record the changes made and the reasons behind each one. This is important not only to maintain the organization and transparency of the adaptation process but can also be useful in quality audits.
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Monitor the progress of activities related to the DRC
Regularly assess how adaptation is impacting your company’s operation and adjust as needed. This helps to identify areas that need more attention, as well as providing a process of continuous improvement.
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Stay flexible
Finally, keep in mind that regulatory changes evolve over time. Therefore, be prepared to adjust your operation as new guidelines emerge. The key to ensuring compliance is to keep an open mind and keep your ears open to all the news, having the flexibility to adapt when necessary.
What are the main RDCs?
The most well-known RDCs are those that regulate health products and services, such as medicines, food, cosmetics, and medical devices. Below, you can learn more about the main Resolutions of the Collegiate Board.
- RDC 44/2009: Deals with Good Manufacturing Practices (GMP) for medicines, defining the standards and procedures to ensure their quality and safety.
- RDC 22/2000: Provides for the basic procedures for Registration and Exemption from the Mandatory Registration of imported products pertinent to the food area.
- RDC 275/2002: Creates Good Food Manufacturing Practices in establishments that produce or industrialize this type of product.
- RDC 658/22: Points out the general GMP guidelines for medicines.
- RDC 512/2021: Shows what are the Good Practices for Quality Control Laboratories.
Conclusion
Now you know what RDC is and understand how they are a crucial tool for the regulation and control of essential products and services in Brazil. By complying with these regulations, you help protect public health and the quality of products available on the market, as well as protect yourself against legal penalties.
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