* According to the requirements of ICH-Q7, through the process validation, to prove the personnel, equipment, materials, methods, process and operation procedures and production environment are able to manufacture the products which can meet the intended purpose and registration requirements, the process is stable and reliable, and meet the GMP requirements. 

* Available Relevant documents for process validation (bilingual version ) :VMP for the project, Risk assessment of workshop introduces the production line, Equipment Suitability Assessment Report, Analysis Method Validation Report,  Batch Record template and corresponding procedures, Demo batch protocol & report, Process Validation Protocol, Process Validation Report, Stability Study Protocol....