1[1]Jeanne Moldenhauer.Performance Qualification of a Stopper Washer[J].Journal of Validation Technology,2001,7(7):158.
2[2]Guidance for Industry-Sterile Drug Products Produced by Aseptic Processing-Current Good Manusfacturing Practice(Draft Guidance)[J].U S FDA,CDER,CBER,ORA,August,2003.