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安全性检查是药品包装材料检验标准的重要内容之一,是确保药品质量安全不可缺少的检验项目。近几年来,笔者在进行药品包装材料生物试验方面的检验工作中发现,药品包装材料现有检验标准有待进一步完善、提高和统一,尤其是与生物安全性检查相关的方法,如细胞毒性、热原、急性全身毒性、皮肤致敏、不溶性微粒、细菌内毒素和无菌检查方法。现将有关问题进行探讨,供药品包装材料标准制修订参考,并提请检验人员、生产企业及药监部门注意。
Safety inspection is one of the important content of pharmaceutical packaging materials testing standards, is to ensure the quality and safety of drugs indispensable test items. In recent years, the author in the biological testing of pharmaceutical packaging materials testing found that the existing testing standards for pharmaceutical packaging materials to be further improved, improved and unified, especially with biosafety inspection methods such as cytotoxicity, heat Original, Acute Systemic Toxicity, Skin Sensitization, Insoluble Particles, Bacterial Endotoxins and Sterility Test Methods. The relevant issues are now discussed for the pharmaceutical packaging materials standard revision reference, and drew inspectors, manufacturers and drug regulatory authorities attention.