The strengths and weaknesses of the quality management system owned by the manufacturers are determined and recommendations are made for the establishment of an effective and feasible system within the scope of GMP, ICH Q10 and ISO 9001 .
Validation Documentation
Documentation and implementation support are provided to manufacturers for product process validation, cleaning validation and equipment qualifications of in compliance with GMP guidelines.
Risk Analysis
All risks on product quality are analyzed proactively and/ or retrospectively by using various risk analysis tools based on ICH Q9 and WHO guidelines, and suggestions are made considering the benefit-risk balance to reduce/ eliminate risks.
Series Documentation
Batch production records and batch packaging records having traceability of all important stages are established in line with GMP rules and Master Formula or existing documents are reviewed for medical product manufacturers.
QMS Review 