Risk assessment is a frequently used term and today almost every industry sector has adopted this in some form as a standard
working practice. The bio/pharma industry must manage the balance between increased regulation and the need to be more efficient
and effective at each stage of drug development and manufacturing, with both factors being driven by the need for continuous
improvement. In particular, it is important to understand what truly represents a risk to a patient or critical information
that is ultimately associated with the care of a patient. If done correctly and consistently, however, business, regulatory
and legislative requirements can be aligned.
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