The concept of quality by design (QbD) in pharmaceutical industry has been introduced to enhance robust manufacturing process and to facilitate product quality. Quality is built in the product and process by design and scientific approach. As the number of out-of-trend (OOT) results, out-of-specification (OOS) results are increasing in pharmaceutical industry and the current quality system is unable to address the growing concern, a strategy to make a robust manufacturing process is felt and a cocept if QbD has emerged. FDA has implemented the QbD concept first in drug formulation manufacturing processes as the finished drug products are directly consumed by the patients and any variation in the quality will adversaly affect the safety of the patients. Similar to robust product development, an equally important analytical methods employed to test the quality of product must be robust and capable of producing accurate results. The benefits of implementing AQbD are 1.con...
Impurities are any organic material besides the drug substances and excipients that may be present as an unwanted guest in the drugs. The presence of these impurities even in small amounts may influence the efficacy and safety of the drug products. Hence ICH, International Council on Harmonization, framed guidelines for identification, reporting and qualification levels of these impurities in different forms of the drugs as mentioned below. 1. Impurities in New Drug Substances in Q3A (R2) 2. Impurities in New Drug Products in Q3B (R2) 3. Guideline for Residual Solvents in Q3C (R5) 4. Guideline for Elemental Impurities in Q3D These guidelines are adopted by US, Europe and Japanese Regulatory authorities. ICH provides detailed information of acceptable level of impurities in the drugs based on maximum daily dosage calculated per day. Beyond certain level, the drug cannot be approved as such by the Regulatory agencies. Regulatory agencies basically look...
Chemical stability of pharmaceutical molecules is most important as it has impact on the safety and efficacy of the drug products. Stress testing or forced degradation is an analytical tool to study the behaviour of the products as well as to understand the resolving power of the analytical method used. Stress testing reveals the quality of pharmaceutical products exposed over the time period as well as different environmental conditions viz., heat, hydrolysis, oxidation, photolytic etc. ICH guideline defines stress testing as: Studies undertaken to elucidate the intrinsic stability of the drug substance. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing. Stress studies provides more valuable information about the degradation impurities, called as degradants, which are likely to form during the shelf life of the product lifecycle in a very short period compared to...
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