A strong quality culture in the biopharmaceutical industry is one in which all participants in the organization understand patient safety and how their roles impact patient safety risks. It is one where decisions are prioritized based on patient safety first. From a GMP perspective, that means not only abiding by the formal law but knowing the applicable current best practices, understanding the risks a company’s processes and products pose to patients and implementing effective quality risk management practices.

Londa Ritchey is Quality Director with the Quality Management and Compliance group at PharmaLex.