Prague will host the 2nd Cleaning Process & Validation Conference on 19–20 November 2025, as regulators and manufacturers intensify their focus on contamination control in pharmaceutical production. The event comes at a time when cleaning validation has moved from a compliance formality to a central pillar of Good Manufacturing Practice (GMP).
Rising Regulatory Pressure
The European Medicines Agency’s revised Annex 1 and recent FDA inspection findings have drawn attention to weak points in cleaning programs. Auditors now expect companies to demonstrate:
- Health-based exposure limits (HBELs) as the foundation for residue acceptance criteria.
- Validated sampling and analytical methods capable of detecting low-level residues.
- Ongoing monitoring and lifecycle verification, not just one-time validation exercises.
Industry Challenges
Despite progress, inspection reports show recurring deficiencies. Firms have faced observations for relying on outdated residue limits, conducting limited swab recovery studies, and failing to document ongoing verification. Equipment design is another frequent issue, with poorly accessible surfaces complicating cleaning and sampling.
What to Expect in Prague
The upcoming conference will address these issues through case studies, regulatory updates, and practical sessions. Key topics on the agenda include:
- Integration of Annex 1 requirements into cleaning and disinfection strategies.
- Equipment design principles that support cleanability and reduce validation burdens.
- Approaches to high-potency APIs (HPAPIs) and biologics, where risk levels demand tighter controls.
- The role of digital tools and data integrity in building audit-ready cleaning programs.
Beyond Compliance
Industry experts emphasize that cleaning validation is not only about avoiding regulatory citations. Well-designed processes can reduce downtime, cut chemical and water use, and improve sustainability. Forward-looking companies see validation as both a compliance requirement and a driver of operational efficiency.
Conference Details
The 2nd Cleaning Process & Validation Conference will take place in Prague on 19–20 November 2025. Further information is available at Speak-Pharma.
