Three Key Takeaways From The PDA Annex 1 Workshop

The EudraLex Annex 1, governing sterile medicinal product manufacturing, has prompted global discussions. PDA's Dublin workshop, the 15th and final in its series, provided a platform for industry professionals and regulators to address critical interpretations and practical applications of the guidance.

Key discussions centered on regulatory expectations since Annex 1's implementation, the crucial role of Quality Risk Management (QRM), and the often-overlooked value of Knowledge Management. Regulatory presenters emphasized that risk assessments cannot justify poor practices, and highlighted the common deficiency of decentralized control strategies. Furthermore, they urged companies to adopt a streamlined, cross-functional QRM approach, utilizing a master plan for comprehensive risk management. The importance of capturing and leveraging personnel's tacit knowledge, alongside robust training initiatives, was also discussed.

To delve deeper into these crucial discussions and understand how they impact your operations, read the full article.