Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards as defined below. Quality risk assessments begin with a well-defined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool and the types of information needed … Read more
PROCESS VALIDATION Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes … Read more
These are possible approaches to gaining a more systematic, enhanced understanding of the product and process under development. Quality Target Product Profile (QTPP): A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. The … Read more
Technology transfer is both integral and critical to drug discovery and development process for new medicinal drug products. A major decision focuses on that point where the idea or process is advanced from a research-oriented program to targeted toward commercialization. Generally, the cost of product development rises dramatically during the pilot scale-up and initial production … Read more
