The fenofibrate micronized powders were prepared using lactose and MCC as the main expicients for preparation of fenofibrate tablets.
以乳糖和微晶纤维素作主要
制备非诺贝特
微粉化物,并以此制备片剂,
以预胶化淀粉调节片剂
溶出度。
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The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
(a) 应设置具有批准和拒绝所有原辅料、药品容器、密封件、中间产品、包装材料、标签及药品的职责与权力的质管理部门。 且有权审查生产记录,确保没有差错,如出现差错,确保展开充分调查。该质
管理部门负责批准
拒绝根据合同由其它公司生产、加工、包装
贮存的药品。
(a)There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.
(a) 应制订并遵循详细描述原辅料、药品容器及密封件的接收、鉴别、贮存、处理、取样、检验和批准拒绝的书面操作规程。