19. Regulations and legislation on pharmaceutical quality control

Página 19

Regulation and legislation on pharmaceutical quality control are essential aspects to ensure the safety, efficacy and quality of medicines available to the population. There are several regulatory agencies around the world that oversee the production, distribution and sale of medicines. These agencies establish strict guidelines and standards that must be followed by all pharmaceutical companies.

In Brazil, the National Health Surveillance Agency (ANVISA) is the body that regulates and supervises all activities related to the production and sale of medicines. ANVISA establishes the Good Manufacturing Practices (GMP), which are a set of rules and guidelines that must be followed to guarantee the quality of the drugs produced. These standards cover all aspects of production, from the procurement of raw materials to the packaging and distribution of ready-made medicines.

In addition to the GMP, ANVISA also establishes specific regulations for the quality control of medicines. These regulations include conducting rigorous tests to verify the purity, potency and stability of medicines. In addition, tests are also required to verify the bioequivalence and bioavailability of generic drugs, to ensure that they are as safe and effective as the reference drugs.

Brazilian law also regulates drug advertising and promotion, to ensure that information provided to consumers is accurate and not misleading. In addition, the legislation also provides for severe penalties for companies that do not comply with the regulations, including heavy fines and the suspension of the license to manufacture and sell drugs.

In global terms, the World Health Organization (WHO) also establishes guidelines for pharmaceutical quality control. These guidelines are adopted by many countries and help to ensure the quality of medicines worldwide.

In summary, regulation and legislation in pharmaceutical quality control are essential to ensure the safety and efficacy of medicines. They help protect public health and ensure that consumers receive high-quality medicines. Pharmaceutical companies must strictly follow these regulations and standards to ensure the quality of their products and to avoid legal penalties.

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2020. Physical-chemical tests in quality control