Prescription drugs have become a major part of preventative care in our nation and many people rely daily on pharmaceuticals to treat a variety of health issues. Mass production is needed to meet the growing needs of this industry and manufacturers rely on color consistency for quality and safety. This technology can be used to verify batch concentrations, leading to rapid and effective analysis for a variety of pharmaceutical products.
Meeting standards and saving money
Quality and safety are a major concern in the pharmaceutical industry and the U.S. Food and Drug Administration (FDA) has developed a set of standards to ensure quality in batch-to-batch production. Batch quality not only keeps patients safe, but also saves pharma companies both time and money. Color consistency analysis provides a rapid and continual method for monitoring large batch pharmaceutical ingredients, ensuring that products meet final inspection standards. Verifying batch concentrations efficiently and accurately not only leads to safer pharmaceutical development, but significantly reduces the amount of wasted product.
The FDA uses PAT (Process Analytical Technology) guidelines as a framework for encouraging “the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance.” Spectrophotometric analysis is an approved method of analysis of pharmaceutical products for measuring color consistency and batch concentrations. Utilizing appropriate technology as an effective method for quality control in pharmaceuticals is a major step towards meeting regulations and consumer demands without compromising patient safety.
The Current Good Manufacturing Practice (CGMPs) regulations for human pharmaceuticals are the main standards used for pharmaceutical quality assurance. Each batch of medications must meet quality standards to be safe and effective. The FDA regulates drug manufacturing processes to ensure that they meet CGMP objectives, and will take regulatory action against drug manufacturers who fail to meet these standards. These manufacturing processes are dependent on advanced technology to monitor production and adhere to these strict regulations.
Using color consistency for product monitoring
In the pharmaceutical industry, color consistency is more than just a measurement of final product color outcome. Spectral technologies use color consistency measurements to verify batch concentrations and to develop precise drug formulations. Although final color measurement is important for color-coding prescription medications, measuring active pharmaceutical ingredients (APIs) is the biggest concern for consumer safety.
Spectrophotometers measure color consistency using advanced light technology. Light absorption values can be used to accurately differentiate slight variations in pharmaceutical plaques and powders. Using color consistency measurements, ingredients can be blended together to create a precise formulation for product consistency, safety, and effectiveness. These levels of color consistency can then be continually monitored to ensure repeatability in pharmaceutical production. Using spectral technology for quantitative analysis ensures that these products meet regulatory standards and consumer expectations. Spectrophotometers are a rapid and affordable method for color consistency analysis and can keep up with the demands of large batch concentration analysis.
Options in spectral technology
Spectrophotometric technology has seen many improvements and changes over the past several decades and new instrumentation options are now available to meet the growing needs of the pharmaceutical industry. At HunterLab, we specialize in pharmaceutical production and color consistency analysis. Our instrumentation is specifically designed to help meet regulatory standards and keep up with the consumer demand. We work closely with leading pharmaceutical manufacturers to develop products that are able to meet the ever-changing needs and challenges of this industry. Our friendly and knowledgeable staff is committed to finding the best solutions for every budget and manufacturing need. For more information on color consistency and batch concentration analysis in the pharmaceutical industry, please contact HunterLab today.
Mr. Philips has spent the last 30 years in product development and management, technical sales, marketing, and business development in several industries. Today, he is the global market development manager for HunterLab, focused on understanding customer needs, providing appropriate solutions and education, and helping to solve customer color challenges across these industries and cultures.