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rdc 654
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RDC 654: How it affects drug manufacturing

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 … Continue reading “RDC 654: How it affects drug manufacturing”

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rdc 749 2022
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Understand the changes of RDC 749 2022 in the pharmaceutical sector

RDC 749/2022 is the Resolution of the Collegiate Board, created by Anvisa to regulate the exemption of bioequivalence/bioavailability studies in producing new drugs — which is called biowaiver. After being published, this resolution led to the revocation of the former RDC 37/1 RDC 37/11. The main objective of the new RDC is to ensure the … Continue reading “Understand the changes of RDC 749 2022 in the pharmaceutical sector”

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what is RDC
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What is RDC (Resolution of the Collegiate Board)?

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. … Continue reading “What is RDC (Resolution of the Collegiate Board)?”

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