307车间胶囊生产线引入奥利司他胶囊60mg,120mg的变更（后续处

Drag capsule production line 307 is introduced orlistat capsules 60mg, changing (subsequent process) 120 mg of the: <br>1. The process related to the product file orlistat capsules 60mg, 120 mg of the final mixed particles revised orlistat pellets, according to the product recipe, its specifications will be set at 50% (W / W), and the establishment of quality standards and stability after packaging quality standards developed based on the file transfer. <br>2. Capsule Orlistat pellets intermediate production process validation batches, samples were taken for stability studies pellets. <br>3. Plan for orlistat pellets large package needs to add for orlistat pellets packed 10kd, 2kg medicinal aluminum bottle supplier Shanghai Shengxin Metal Container Co., Ltd., and suppliers review. "

307 workshop capsule production line introduced Olista capsule 60mg, 120mg change (follow-up treatment):<br>1. In the product process-related documents, Olista capsule60mg, 120mg final mixed particles revised to Olista micropills, according to the product formulation, its specifications as 50% (W/W), and according to the research and development transfer documents to establish post-packaging quality standards and stability quality standards.<br>2. When Olista capsule process verifies the production of intermediate micropills, sampling is carried out for the stability study of micropills.<br>3. Plan to carry out large packaging of Ollista micropills, need to add 10kd for Olista micro-pill packaging, 2kg pharmaceutical aluminum bottle supplier Shanghai Shengxin Metal Container Co., Ltd., and suppliers to review. "

Change of 60mg and 120mg orlistat capsules introduced into capsule production line of workshop 307 (subsequent treatment):<br>1. In the relevant documents of the product process, the final mixed granules of 60mg and 120mg of orlistat capsule were revised to orlistat pellets. According to the product formula, the specification was set as 50% (w / W), and the post packaging quality standard and stability quality standard were established according to the documents of R & D transfer.<br>2. During the production of orlistat capsule process validation batch intermediate pellets, samples were taken to study the stability of pellets.<br>3. It is planned to carry out large-scale packaging for orlistat pellets. The supplier of 10kd and 2kg medical aluminum bottles for orlistat pellets shall be added to Shanghai Shengxin metal container Co., Ltd. and the supplier shall be reviewed. "<br>