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process validation - Coggle Diagram

- - - - 4.1.3 process design of WuXi Biologics
        
        4.1.4 process design
        
        4.1.4.1 Quality Target Product Profile Report (QTPP)
        
        4.1.4.2 Critical Quality Attributes (CQA)
        
        4.1.4.3 Manufacturing Process Flow Diagram
        
        4.1.4.4 Risk assessment for Pre-Process Characterization
        
        4.1.4.5 Qualification of Small Scale Models
        
        4.1.4.6 Validation/verification/qualification of Analytical Mthods
        
        4.1.4.7 The protocal and report of Process Characterization Study
        
        4.1.4.8 Risk assessment for Post-Process Characterization
        
        CPP
        
        KPP
        
        GPP
        
        4.1.4.9 Process design report
  - - - 4.2.2 Key elements of Stage2
        
        4.2.2.1 PPQ MP
        
        4.2.2.2 Prerequisites of Process Qualification
        
        ① design and qualification of the facility, equipment and utilties
        
        ② review IOPQ documents
        
        ③ selection and suirability of cleaning agents for product-contact surfaces
        
        ④ establish the program for equipment PM, instrument clibration and CC
        
        ⑤ Acquisition of preliminary process date and knowledge early in stage 1
        
        ⑥ personnel training
        
        4.2.2.3 PPQ options, approaches and scale of studies
        
        4.2.2.4 PPQ
        
        ① VC study
        
        ② Impurity Clearance
        
        ③Process Consistency Study
        
        ④Process Intermediate Stability
        
        ⑤Process Solution Stability
        
        ⑥DS fill, freeze, thaw and storage
        
        ⑦ mixing study
        
        ⑧ resinn and membrane lifetime validation
        
        ⑨filtration reprocessing
        
        ⑩end of production cell bank
        
        11 E&L
        
        4.2.2.5 PPQ protocal Execution
        
        4.2.2.6 PPQ reports
        
        4.2.2.7 post-PPQ RA
    - - 4.3.1
        
        4.3.2 Key elements of Stage 3
        
        ① Roles and responsibilities of various functional groups
        
        ②Sampling and testing strategy
        
        ③Data analysis methods
        
        ④Acceptance criteria
        
        ⑤strategy for handling OOT and OOS
        
        ⑥Mechanism for determining what process changes/trens require going back to Stage 1/2
        
        ⑦timing for re-evaluation of CPV testing plan
      - 4.4 Process Re-validation