Pharmaceutical finished dosages form projects
Vendor assessment audits for plant.
Assessment of
Plant layout design, equipment, infrastructure, process flow, flow of men & materials, raw materials and finished product storage, Documentation.
CAPA and Risk arrangement and appropriate mitigation and contingency plan
GAP Assessment
Validation and Qualification
GMP Approval from regulatory authorities
Training and skill development
Cleaning validation
Contamination and Cross-contamination
GMP, GLP
Quality Risk Management
Pharmaceutical Quality System
Data Integrity
Qualification and Validation
Process Validation
