| Popis: |
Product or Quality details are one of the three types of information that regulators require for decision-making. These details are derived through science-based methods and data are gathered as manufacturing processes are developed and optimized. Processes must be validated by the time of later stage development in all regulatory jurisdictions. All of this development occurs in a context of Quality systems’ oversight and control. Documentation is critical to a well-controlled manufacturing environment. Validation is the manner in which the process performance parameters and reliability are established, so that the data produced can be taken as reliable and credible. In this manner, consistent products can be manufactured and quality designed into the production processes. Because regulators make science-based and evidence-based decisions, the application of regulatory science to product manufacture, including during development, is key to success. |
