Agencies strictly control the global pharmaceutical sector, establishing and monitoring guidelines to ensure the safety and quality of products, both those sold and those in the approval process. Additionally, these agencies play a crucial role in the ongoing oversight of manufacturing practices, thereby ensuring that standards are maintained at all stages of the product lifecycle.
ANVISA standards and Brazilian Pharmacopoeia
In Brazil, the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency – ANVISA), created by Law No. 9,782 of January 26, 1999, is responsible for establishing standards through resolutions of the collegiate board (RDCs), informative guides, technical notes and other official documents . In addition, ANVISA also prepares the Brazilian pharmacopoeia, a compendium that describes production methods for pharmaceutical products. Consequently, this pharmacopoeia ensures greater safety in industrial production, especially in preventing the formation and storage of impurities that may arise during the pharmacotechnical or storage process.
Types of Impurities and Quality Control
Undesirable substances found in the pharmaceutical ingredient or finished product, which are not the active ingredient or its excipients, are impurities. We classify these impurities as:
- Organic and Inorganic: Originated during manufacturing or storage.
- Residual Solvents: Remain after synthesis processes.
Importance of Guidelines and RDC No. 658/2022
Due to the high health risk that these impurities represent, health surveillance agencies require pharmaceutical industries to maintain sectors specialized in quality control, issuing technical reports to facilitate inspection. In Brazil, these sectors must follow RDC No. 658/2022, which establishes general guidelines for good drug manufacturing practices. In addition, there are also specific standards for quality control depending on the type of medicine or product.
Forced Degradation Procedure
An example of a procedure carried out by quality control sectors is forced degradation. In this method, the product is subjected to stress conditions such as light, temperature, humidity, heat and acidification to identify the conditions under which it begins to degrade and release potentially harmful metabolites. Furthermore, this method provides valuable information about how the product should be stored and guides industries in improving manufacturing routes. Furthermore, ANVISA regulates these procedures through RDC No. 53/2015.
For more information, see:
