Practical GMP Workshop in Kyiv
Industry experts shared current approaches to quality, validation and risk management.
The ISPE Ukraine practical workshop brought pharmaceutical manufacturing, quality, engineering and validation professionals together in Kyiv. Instead of repeating GMP requirements, the session focused on turning them into clear, workable decisions for operational teams.
From requirements to working processes
Participants followed the complete path from a regulatory expectation to a specific procedure on the shop floor. The speakers demonstrated how risk assessment, equipment qualification, change control and deviation management can operate as one coherent system.
Particular attention was given to documents that formally meet a requirement but do not help people make decisions. Using practical examples, the group explored how procedures can become shorter, clearer and more useful for the colleagues who apply them every day.
Key workshop topics
- risk-based qualification and validation;
- managing change without losing process control;
- deviation investigations and root-cause analysis;
- building defensible evidence for inspections;
- collaboration between manufacturing, quality and engineering teams.
Working through realistic scenarios
During the practical session, participants worked in small groups. Each team received a scenario involving a manufacturing process change, incomplete source data and a potential impact on product quality. Their task was to identify the critical risks, define the necessary actions and justify the scope of requalification.
This format allowed professionals from different companies to compare approaches and see that the same requirement can be implemented in several valid ways. The key outcome was not one “correct” answer, but a transparent decision-making process that could be explained to colleagues and inspectors.
A resilient quality system begins when a team understands not only what must be done, but why it matters to the patient and the process.
What participants took away
At the end of the workshop, every participant prepared a short improvement plan for their organization. Priorities included reviewing risk-assessment templates, defining responsibilities between functions more clearly and creating regular multidisciplinary discussions for complex changes.
ISPE Ukraine will continue to create space for practical knowledge exchange. Future sessions will develop the themes of computerized system validation, data integrity and modern approaches to technology transfer.