On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take pl
The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. It ha
On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to bre
Supply chain oversight: what to expect from —and how to prepare for— an increasingly global supply chain and heightened FDA scrutinyAs more drugs are manufactured overseas and supply chains become
今年四月份公司生产的三批工艺验证批胶囊其中一批成品溶出度结果偏低(该批溶出度结果单值未超下限但普遍偏低,且均值相比同工艺验证另外两批
WHO 3月30日发布的数据可靠性指南中 4.10 中 database build, data collection, data review, blinded data, randomization 中 blinded data 如何理解?
比如当炽灼残渣标准限度为<0.1%时,是否可以不做平行样? 背景:①原料药特别昂贵,如进行平行样至少要多用1g;②中国药品检验标准操作规范2010
高致敏、高活性、细胞毒等产品生产可能会有活性物质残留在洁净服上,在更衣时洁净服上的活性物可能会经呼吸或者粘附到人员的体内或者自身衣服
变更管理办法规定要依据技术指导原则进行充分评估和研究,确定类别,对于需要经批准,备案后实施或报告的有关变更,在申报期间可否同步开展了
药品研发过程中,质量标准与检验SOP会不断更新升级,那么稳定性试验检验过程中,应遵循哪个版本的检验SOP呢?比如检验SOP里有关物质计算公式变了
中试生产中,对原辅料的要求是级别越高越好,像有些添加物没有临床级别的,只有科研级别的,使用后有什么注意事项?比如人胰岛素作为细胞培养
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179