All about CMC

When developing and releasing pharmaceutical products to the market, ensuring their safety and efficacy is of critical importance. Determining the impurity profile is a must, and a vital part of it is the analysis and assessment of the extractables and leachables (E&L) resulting from the interaction of the pharmaceutical products and the packaging (container-closure systems, (...)

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Stability testing is an essential part of drug development as it ensures the efficacy and safety of the medicinal product throughout its shelf life. It allows the evaluation of APIs and drug product stability under the influence of various environmental factors that will enable us to determine their behavior and changes over time. Being such (...)

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Characterization of unknown impurities found in pharmaceutical substances and pharmaceutical products is a vital part of the regulatory approval process. According to ICH guidelines, if the estimation indicates an impurity content higher than 0.1%, it must be identified and characterized ensuring compliance with all regulatory requirements. This process is also known as impurity profiling. The (...)

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The US Food and Drug Administration (FDA) has taken a significant step to address the mutagenic and carcinogenic risk associated with Nitrosamine Drug Substance-Related Impurities (NDSRIs). This past August, the FDA introduced a final guidance framework that not only predicts the risks but also sets recommended acceptable intake (AI) limits for NDSRIs in drug products (...)

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As stated by the EMA (European Medicines Agency), residual solvents are organic volatile chemicals used or produced during the manufacture of active substances or excipients, as well as in the preparation of veterinary medicinal products. These solvents are not completely removed by standard manufacturing techniques and can pose risks to the target animal and consumers (...)

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