Good Manufacturing and Distribution Practices
The implementation of Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) are essential to ensure that medical devices are manufactured, stored, transported, and delivered safely, effectively, and in full compliance with regulatory and quality requirements.
We offer support in evaluating, developing, and improving manufacturing and distribution processes, ensuring they comply with the principles of good practices and applicable regulations, including the MDR (Regulation (EU) 2017/745), IVDR (Regulation (EU) 2017/746), and ISO 13485.
Our services include
Analysis of existing manufacturing and distribution processes
Analysis of existing manufacturing and distribution processes, identifying gaps and improvement opportunities
Implementation or enhancement of quality systems
Implementation or enhancement of quality systems based on Good Practice principles, focusing on traceability, document control, process validation, environmental control, and staff training
Support in preparation for audits and inspections
Support in preparation for audits and inspections, ensuring all process stages are properly documented and compliant
Ongoing consultancy
Ongoing consultancy in maintaining compliance, including monitoring of legal requirements and applicable good practices
