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Validation of Quality Control Labs


  • Validation of Quality Control Labs

    • Overview


     Schematic diagram of lab lifecycle and relevant activities:
    Validation consultation services that can be provided by Austar for the above lab lifecycle are as follows:

    1) GMP review & review report for lab design

    Overall layout of lab                                                                           
    Layout of equipment and instruments
    Work flow                                                                                             
    Sample flow
    Waste flow
    Toxic waste flow
    Utilities                                                                                         
    EHS
    Quality assurance system                                                                                 
    Documentation system
    Personnel                                                                                                  
    Facility and Equipment
    Raw materials and excipient and their suppliers                                                                              
    Sampling and samples
    Test                                                                                                 
    Test result and release

    2) Compilation and review of lab system documents




    3) Lab validation
    Analytical method validation: physicochemical method/ microbiological method/ biological activity test method/ cleaning and sanitization procedures 
      
    Analytical instrument qualification: physicochemical lab/ microbiology lab/ biology lab


    4) Quality management for a lab
    Quality manual of the lab                                                                               
    Quality control plan of the lab
    Risk assessment report of the lab testing methods                                                    
    Impact assessment report of lab equipment and instruments
    Lab risk assessment report                                                                      
    Microbiological lab risk assessment report

    5) Relocation services for a lab
    Summary of a lab relocation execution process
     

    Relevant documents on lab relocation
    Master plan for lab relocation                                                                         
    Risk assessment report for lab relocation
    Lab relocation schedule and project management                                                      
    Necessary BSL lab instrument cleaning and decontamination report
    Relocation protocol for lab instruments                                                                        
    IOPQ/ CAL/ PM protocol & report for lab instruments
    Periodic reports for lab relocation                                                                    
    Overall report for lab relocation
    Handover

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