• 


      


      



      金年会 | 诚信至上金字招牌
      




    
      
        
      
            
            
            
            
      
                
      ENG
      
                
            
      
        
      
    
      
    
    
    
            
        
      
            
      
                
      
                    
                    
                
      
                
      
                    
      
                        
      
                        
      
                            Solution & Service                        
      
                        
      
                    
      
                
      

                            
      
        
      
        
                
    








    
      
        
      
            
            
      
            
      
            
      
                
      
                    
                    
      
                        
      
                            
      
                                
      
                                    
      Process Validation
      
                                
      

                                 
                                      
                                                                                
      
                                            
      
                                                
      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
      
                                            
      
                                        
      
                                                
                                        
                                                                                

                                                                                                
      
                        
      

                    
      
                
      
            
      
        
      
            
    
      
    




    


    
    
    
    






      友情链接: