The manufacture of sterile medicinal products is a risk-prone process. Whereas the product safety of terminally sterilised products can usually be ensured by validating the sterilisation process, aseptic manufacture makes great demands on process safety. As early as 2001, the FDA had defined the „Risk-Based Approach“ for future inspections; involving high risk in the sense of the authority‘s definition and therefore being automatically in the focus of inspections is „aseptic processing“.
Even in advance, one has to study the question whether each process step poses a contamination risk, and if so, which one. Good risk management consists in identifying and assessing risks in time and taking measures in the production process in order to control or - if possible - eliminate these risks.
Everyday routine confronts us with a multitude of potential risks. Which of them are critical, which ones rather uncritical? How can risk assessment be done and which rationales play a role in this decision?
The speakers provide you with practice-oriented approaches to assessing, controlling and reducing risks in -sterile processes- and to get safely through inspections.