Glims pharm9/19/2023 ![]() They employ digital tools like smart glasses to translate standard operating procedures into step-by-step visual guidance on how execute a process. These labs transition from manual data transcription and second-person verification to automatic data transcription between equipment and the general laboratory information-management system (GLIMS).ĭigitally enabled labs use advanced real-time data analytics and ongoing process verification to track trends, prevent deviations or out-of-specifications, and optimize scheduling. Most pharma labs have not yet achieved digital transformation, but labs can aim for one of the three future horizons of technological evolution (Exhibit 1).ĭigitally enabled labs achieve at least 80 percent paperless operations. Multiple digital and automation technologies have created opportunities for change in pharmaceutical laboratories. To succeed in the future, pharma companies need both the foresight to make long-term strategic investments, including those in R&D for developing and filing new test methods, and the agility to adapt those plans as technologies rapidly evolve. To capture opportunities offered by existing and emerging technological advances, companies should set clear goals, define robust business cases for any level of investment, and engage in rapid piloting of the new technologies followed by fast scale-up of pilots that deliver promising results. Now those moves are being superseded by new advances in equipment connectivity that enable direct transcription of thousands of data points without any manual data transcription and without any reviews. For example, many companies have already taken steps to become paperless by first simplifying paper records to minimize the number of entries and then digitizing lab testing records. On the other side, companies rarely develop a clear long-term lab-evolution strategy and blueprint, which can lead to some costly investments with unclear benefits. On one side, quality leaders often struggle to define a clear business case for the technological changes, which makes it difficult for them to convince senior management that lab digitization or automation can deliver significant impact. While most of the advanced technologies already exist today, few pharmaceutical companies have seen any significant benefits yet. Furthermore, improved agility and shorter testing time can reduce QC-lab lead times by 60 to 70 percent and eventually lead to real-time releases. Prevention of major compliance issues can in itself be worth millions in cost savings. Use cases have demonstrated more than 65 percent reduction in deviations and over 90 percent faster closure times. Digitization and automation will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and effective resolution of problems. The first real-life use cases have delivered 30 to 40 percent increases in productivity within already mature and efficient lab environments, and a full range of improvements could lead to reductions of more than 50 percent in overall quality-control costs. USP training and service are designed to help you meet regulatory compliance requirements while strengthening your quality standards.The emerging technologies that characterize Industry 4.0-from connectivity to advanced analytics, robotics and automation-have the potential to revolutionize every element of pharma-manufacturing labs within the next five to ten years. Where specified in a monograph, USP dissolution tests are legal requirements. General chapter Dissolution includes 4 standardized apparatus: basket, paddle, reciprocating cylinder, and flow-through cell. ![]() ![]() This standardization helps to show consistent quality in production and may serve as a predictive measure of efficacy.Ī dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. To properly evaluate the dissolution of drug products, it is critical for procedures to be standardized. Dissolution and drug release are terms used interchangeably. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. Modernization & Priority New Monographsĭissolution is the process in which a substance forms a solution.Pharmaceutical Analytical Impurities (PAIs). ![]()
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