A survey by the International Society of Pharmaceutical Engineering (ISPE) indicates among manufacturing quality systems, aseptic processing equipment and production systems are key issues in the recent rise in drug shortages. Designed to determine the quality and manufacturing issues related to drug shortages, the anonymous survey was conducted in February and March and consisted of responses from 175 individuals and 37 companies. Fifty percent of respondents have experienced a shortage, and 30% have experienced a “near miss.” Among respondents that cited production systems as a contributing factor, nonconformances and process validation were named as the most common issues. For the 43% of respondents that were successful in preventing drug shortages, the top three factors cited as most important were strong quality systems to ensure compliance, a corporate goal of avoiding drug shortage, and a strong quality system record and GMP inspection history.

Source: ISPE