Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management. Beatrice heads Quality at Abbott and used to serve as deputy director of CBER at FDA. The seven items to avoid, he notes are: bureacracy, tradition (just because you’ve always done something a certain way doesn’t make it right), excess (too many priorities), isolation (lack of communication among groups and with public), deafness (not listening to employees at all levels), and complacency.
Beatrice offered three key tools for managing quality and dealing with challenges such as globalization and economically motivated adulteration: quality management reviews, certification, and knowledge management. Quality intelligence, he noted, is key. Companies need acquire, analyze, and share information across all divisions, sites, and groups.
Beatrice also described how Abbott took 221 corporate policies and got them down to 17 such policies that were able to meet global GMP standards for the 130 plus markets that the company works in. GMPs are not a menu–you can’t pick and choose which ones to follow, he said. There is a way to group GMPs and find tools and procedures that can enable compliance across the board. The model that Abbott used involved starting with the policy or regulation, interpreting that policy, setting an application/procedure for carrying it out, and aligning a toolbox with it.
When talking about the various GMPs companies must follow today, Beatrice highlighted the World Health Organization. WHO is becoming a regulatory agency, he said. Companies need to pay attention to what the organization is doing because WHO is working with regulators and organizations worldwide.
More to come from ExcipientFest this week….