ABSTRACT
Mergers and acquisitions within the pharmaceutical sector have become the norm in recent years and bring with them complex product portfolios involving long or even extended product lifecycles. Organizing and preserving prior knowledge can be a daunting task in the post-acquisition environment. The Roche knowledge management (KM) approach is built upon the principles described in ICH Q10. Improved document sharing would yield significant productivity value. A strategy to improve identification of product lifecycle documents was developed with the initial focus on the source documents that support regulatory submissions. The product history file (PHF) provides an index of the pharmaceutical quality system (PQS) documentation requirements to support commercial products. Product knowledge comes from various sources that collectively provide a detailed and comprehensive product and process history. A pilot program was proposed to create PHFs for five products spanning the Roche product portfolio to develop the business process and identify resource requirements for the program.
