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...
Elemental impurities are traces of metals carried from raw materials, residual catalysts, manufacturing equipments, process water, excipients, containers that can be observed in finished drug products. These elemental impurities do not have any therapeutic effect and is harmful to patients due to their toxicity beyond certain limit. The presence of trace elements were tested classically by using USP's Heavy metals test, <231> , which uses as a colorimetry test by forming as a sulphide precepitate with elements. In the last decade, PDE (permitted daily exposure) of almost all elements are found which leads to monitor and control the individual elements in the drugs by measuring their level by using modern instruments like ICP OES, ICP MS etc. ICH developed a guideline specifically on Elemental impurities as Q3D and list the PDE values for each element. Based on PDE value and the route of administration ( orals, parenteral, nasal) values are diffe...
Comments
Post a Comment