In the context of GMP inspections, how should data integrity…

In the context of GMP inspections, how should data integrity be understood with respect to GMP records and documentation?                                                                                                                                       

During the manufacturing of a sterile injectable, a filter s…

During the manufacturing of a sterile injectable, a filter shows a small defect. No contaminated batches have been detected yet. At what point does this defect (hazard) become a risk?