The process of identifying and quantifying a GXP risk within any component of drug development and manufacturing is often done inefficiently, most often due to the focus of the exercise not being correct or as welldefined as it could be. In many cases, this can be attributed to the risk assessment process being inappropriate and/or over-complicated. The purpose of the process is not to generate comprehensive reports, but to identify where there is potential risk to the patient and then to eliminate or minimise this risk.
The International Society for Pharmaceutical Engineering (ISPE) Baseline Guide and Good Automated Manufacturing Practices (GAMP) documentation provides an excellent foundation upon which to base risk assessment. In accordance with these guidelines, it is necessary to conduct an objective assessment of each system and activity. It is important to challenge the way things have been done historically, as well as the way things are done in different parts of the organisation, as these may not always be the most appropriate solutions.For instance, the classification of environmental conditions for a work area can have a significant cost impact in terms of design, installation, validation and ongoing monitoring. For pharmaceutical companies, it is important to consider whether reducing the classification across elements of drug manufacturing can have an impact on product safety. By challenging the classification necessary to conduct GMP/GLP operations within an environment that is adequate for the operation, companies may be able to achieve significant savings. A value engineering study must challenge all areas of drug development and manufacturing, including quality, and must not be restricted to new facilities, as the robust review of existing facilities is also often beneficial.