Quality/Compliance Services
Pharmapath is GMP certified by Local and International Health Authorities (ANVISA – Brazil, Gulf Cooperation Council – GCC, Ministry of Health of Russian Federation) and can offer to its partners a wide range of highly professional quality-related services in compliance with EU GMP and international standards. Our Quality System is being succesfully audited routinely by our customers including the most recognized European generic pharma companies.
EU Batch Release
Suppliers’ Qualification
Auditing processes, evaluation of alternative resources, CAPA management and follow-up.
Quality Risk Management
Wide experience in risk evaluation for different segments such as excipients, elemental impurities, Nitrosamines and manufacturing processes.
Process Validation and Continued Process Verification (CPV)
During product development or technology transfer activities.
Stability Studies
Trend analysis, evaluation and relative reports.
Product Quality Reviews (PQRs)
Towards overall process robustness evaluation based on advanced statistical analysis of Critical Quality Attributes.