From RFID and pedigrees to PAT and process understanding, industry professionals are eying the growing gap between ambitious high-level guidance and current practice, and wondering how they can bridge this new space and keep in compliance with the untested rules.
Pharmaceutical Technology provides perspective on pharmaceutical manufacturing activity, assessing the product portfolios, prescription volumes, revenues, and capital spending plans of more than 500 drug-makers. Novartis leads in diversity, with 889 products; Pfizer leads in number of scrips (352 million) and revenue ($44 billion). And generics companies are coming up on the inside.
This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.