This would assure regulatory bodies that there is total consistency from site to site. Ideally, each facility would operate from a single primary recipe for each product. More companies are turning to digital batch management to ensure this consistency. How does a pharmaceutical company prove that a product being produced at several facilities is meeting the same strict requirements for each? While this new direction has created needed flexibility in meeting shifting demands, it has also prompted regulatory bodies to question the consistency of quality for drugs being sold under a single brand name. 3 rd party manufacturing sites have also been normalized as part of the global network. In the past 20 years, pharmaceutical companies have evolved from having blockbuster drugs manufactured at dedicated facilities towards diverse, multi-product facilities across the supply chain. To learn more, download ARC’s whitepaper on Smart Manufacturing in the Life Sciences Consistent operations drive regulatory compliance Now more than ever, digital transformation can be the driver of both compliance and flexibility. This transformation provides both the regulatory consistency and the flexibility that have in the past been opposing concepts in the pharmaceutical industry. To meet these demands, companies are more frequently looking to transform their operations by implementing digital batch management. How do pharmaceutical companies balance these requirements with the need to have a flexible supply chain? The emergence of large economies like China and India, aging and shifting populations, and personalized medicine are all contributing to the need for a more globalized and flexible supply chain. Of all the challenges companies face in their quest for globalization, the lack of harmonized regulatory requirements they face can be the biggest obstacle. Some of these regulations, like data integrity, are relatively consistent across the globe while others, like serialization requirements, vary greatly from country to country. This streamlines the new product introduction (NPI) process and helps you respond to changing market demands with greater agility.I’ve discussed some of the new regulations facing the pharmaceutical industry in past posts. The control-system-neutral approach allows for recipe and batch standardization across the business. Automation of the batch processes delivers consistent quality to recipe specifications, maximizes asset utilization, helps eliminate paper records, and reduces batch release cycles. Coordinate everything with the plant control systems, interface with the operators, and direct batch activity, material flow, and production data to a historical database for a full electronic batch record (EBR).ĪVEVA Batch Management software helps manufacturers to improve yields through increased product quality and operational efficiency. Adhering to the ISA-88 standards for batch control, AVEVA Batch Management provides guidance and oversight to both recipe management and batch execution. Effectively manage flexible batch operations found in process industries, including life sciences, fine chemicals, and food and beverage/CPG.
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