Rational Revalidation

The economic problems the world is currently facing have caused severe cost pressure on pharmaceutical manufacturing. Revalidation of manufacturing processes and equipment comprises a significant cost to the industry. Maintaining a validated status is a regulatory requirement. Technical issues, patient risk, and business considerations impact the organizational approach to revalidation. This discussion addresses the need for revalidation with particular attention to business considerations. Strategies to prioritise revalidation among systems and how to decide on what, how, and when to revalidate are discussed. Alternative approaches when revalidation is not possible are suggested. Costs associated with revalidation are described. Activities to reduce the need for revalidation including statistical process control are discussed. Business models for approaching revalidation including in-house and outsourcing are considered. Change management is a key component of a revalidation program. Also key is a structured approach to validation maintenance as time-based and eventbased. Considerations in these discussions do not compromise patient safety and product quality. Business factors only determine the order in which the systems are to be revalidated. Under no circumstances would the product of a manufacturing process that is not validated to regulatory expectations be released to the marketplace. [PUBLICATION ABSTRACT]