The regulation of the pharmaceutical industry imposes strict standards and guidelines for daily operations in an effort to protect the health and safety of those for whom the products are intended. Regulatory groups including the Food and Drug Administration (FDA) dictate protocol, procedures, reporting and more. Adhering to these protocols, while necessary, can be complex and time consuming. So an enterprise wide implementation that embraces these regulations can make compliance with them more bearable. What if a system was in place to continually monitor all stages of the product life cycle, automatically alerting the appropriate personnel when compliance indices fall short? Maintaining compliance is simplified and more successful.
The Statistica Enterprise software is the global standard GxP analytics platform for empowering engineers, analysts, operators, scientists, managers, and customers with role-based access to data, standard analyses, and reports in order to support process understanding, process monitoring, and regulatory compliance.
In the pharmaceutical industry, many implemented processes are both automated and continuous. The types of manufacturing involve complex sequences of steps and operations as raw materials move through each step. After the process is completed final drug quality will be determined by the sometimes complex interactions between upstream and downstream processing, raw materials, media, and instrumentation. In order to perform meaningful reporting, process monitoring, root cause analyses, and process optimization based on data collected at each step, it is necessary to manage views across processing steps, and across time.
Standardized Stability and Shelf Life Analysis is a required step in the manufacture of all drugs and foods, to determine the shelf life. In general, the concern is that products retain the same properties and characteristics that they possessed at the time of packaging. These properties must be within specified limits throughout a period of storage and use.
Pharmaceutical manufacturing processes are subject to stringent validation requirements to ensure product (drug) quality. This industry is critical to society’s health and well-being – thus, their processes must be highly regulated.