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Predictive modelling: putting ICH guidelines to work in process validation: when applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.

Article Excerpt
Through the International Conference on Harmonisation (ICH) process, regulatory bodies in the EU, US and Japan have been moving steadily towards a science-based approach to drug development that will revolutionize the way pharmaceutical companies validate processes and ensure product quality. Concepts such as PAT, quality by design (QbD) and design space (DS), which figure prominently in ICH Q8 and ICH Q9, (1), (2) encourage greater scientific understanding of processes and products, and hold out the promise of a lighter regulatory burden for companies that adopt such principles. Although the regulatory agencies have provided some helpful direction about how to put these principles into practice, they have not laid out a step-by-step guide. In the absence of such guidance, many companies have been slow to take advantage of the opportunities that these changes offer.

That hesitation is understandable. Consider the uncertainty surrounding validation of manufacturing processes--a key milestone in the drug approval process. The industry knows that the accepted approach to validation--the successful processing of three consecutive batches--is antiquated. Further, FDA, for example, now says that it never meant the three-batch guideline as a hard and fast rule. As recently as 2003, in the pages of this publication, a review of the literature on validation uncovered wide variations among experts in their understanding of the term and the regulatory requirements associated with it.3 However, by following a proven approach to science-based validation, forward-looking companies can cut through the uncertainty, move past outdated methods of validation and begin to realize the potential of recent ICH guidelines:

* reduced compliance risk

* greater regulatory flexibility

* more robust processes

* significant financial benefits.

The goal: managing variability

As anyone who has been involved in validating a pharmaceutical process knows, the apparently simple equation 'fixed raw materials...