GMP Qualification & Validation Consulting
1.Guide the clients to complete risk-based qualifications/validations compliant with both US/EU/WHO/Chinese GMP requirements and good industry practices, covering facility & equipment qualification, process validation, cleaning validation, analytical method validation and computerized system validation
2.Establish risk-based master validation plan and validation plans in combination with facility design, and guarantee continual GMP compliance of qualifications/validations via complete quality plans
3.Based on a bilingual validation team with rich experiences in high-end projects of bio/pharmaceutical products, provide complete qualification/validation protocols as well as qualification/validation reports based on experimental/measured data provided by clients/third parties