1Associate commissioner for regulatory affairs - United States Food and Drug Administration compliance policy guide 7132a.13. Parametric release terminally heat sterilized drug products [EB/OL]. [2006-3-10]. http://www.fda.gov/.
1Associate commissioner for regulatory affairs. United States Food and Drug Administration compliance policy guide 7132a. 13. Parametric release-terminally heat sterilized drug products[S].
2Eu GMP Annex 17. Parametric release 2001[S].
3Parenteral drug association, Inc. Technical monograph No. 1. Validation of steam sterilization cycles[S].
4Pflug IJ. Microbiology and engineering of sterilization processes [M]. Philadelphia:Pa. Parenteral Drug Association, 1977. 210-236.
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6ISO 11134. Sterilization of health care products-Requirements for validation and routine control-Industrial moist heat sterilization[S].
7The European agency for the evaluation of medicinal product CPMP/QWP3015/99. Note for guidance on parametric release[S].
