项目生产工艺总结报告模板

2Y CHEM LTD Document Code 2020 3 311 6 XXX 项目生产总结报告项目生产总结报告 或者 或者 XXX 项目工艺验证总结报告 项目工艺验证总结报告 中文版中文版 产品名称 产品名称 CAS 号 号 产品代号 产品代号 生产地点 生产地点 生产日期 年生产日期 年 月月 日日 产出 产出 总重 总重 批数 批数 目录 1 概述 1 2 合成路线 2 3 工艺操作规程 SOP 2 3 1 第一步 2 3 1 1 反应方程式 2 3 1 2 原料投料表 2 3 1 3 工艺规程 2 3 2 第二步 2 3 2 1 反应方程式 2 3 2 2 原料投料表 2 3 2 3 工艺规程 2 4 新工艺与旧工艺的对比变化 2 5 批数据总结 收率 纯度 规模 2 5 1 中间体和成品数据总结 2 5 2 中控总结 2 5 3 中间体纯度总结 2 6 生产后要点总结 讨论 2 6 1 第一步 2 6 2 第二步 2 6 3 试产中发现问题和注意事项 2 7 生产批次 COA 原始数据列表统计 2 注意 每部分的具体内容要求 参见下面英文版说明部分 2Y CHEM LTD Document Code 2020 3 312 6 XX project code Campaign Report 英文版英文版 Product Name CAS Product code Manufacturing Site Date Target kg 1 Introduction 简要介绍工艺或中试研究的背景 目的 生产地 成果等 或这种大事件的简要描述 评 价一下生产 A short summary of the total work May include the background goal achievement etc The following is an example On June 24 2005 we were assigned GMP preparation 600g of XXXX An eleven step synthetic procedure was originally provided by XXX ref 1 The original synthesis was developed by XXX ref 2 During the developmental work carried out concurrently we modified the initial four steps to obtain intermediate phenol 4 in high yield and purity After the last submission of XXX 300g 5 17 05 we changed the preparation of acetophenone 9 The use of XXX step was replaced with lithiation and subsequent coupling with DMF to produce the require ketone 9 The modified synthetic route used in the current preparation is outlined above Due to multi step nature of the synthesis it was decided to prepare intermediates 7 and 9 under non GMP conditions Intermediateds 7 and 9 were then qualified for GMP and used in the preparation of the XXX Treatment of commercially available XXX with XXX resulted in the carbonate 1 98 Nitration of the ethyl carbonate 1 in sulfuric acid afforded crude XXX 1a Reduction of the above crude nitro compound 1a was carried out in ethyl acetate using 10 palladium on carbon The catalyst was filtered and the product solution of 2 was treated with pyridine 1 2equ and pivalolyl chloride 1 2equ The workup resulted in crude intermediate 3 The crude carbonate 3 was then hydrolyzed using sodium carbonate in aqueous methanol and acidified to yield XXX 60 4 yield over 4steps the following is the description of the next steps Intermediates 7 2717g Lot ML 09 134 and 9 1425g Lot PKG 10 172 were used in the 2Y CHEM LTD Document Code 2020 3 313 6 GMP preparation of XXX Lot No XXX 2 Reaction scheme 包括起始原料 中间体 主要试剂和主要反应条件 The scheme should include starting materials intermediates main reagents and the main reaction conditions 3 Procedure 格式参见工艺模板 Procedure of XXX template 4 Changes comparing with the previous procedure if available StepsChangesAdvantage ABC 0The volume of dichloromethane was decreased from 88vol to 33 4vol The volume decreased about 2 3 of original The cost was decreased and the reactor efficiency was increased 5 Batch summary yield purity scale 至至少应分步对各批投料规模 产品数量 收率 纯度进行比较 同时应分析与前次中试或 中试以前的经典反应批相比发生的偏差 StepBatch No SM kgproduct kgYieldPurity ABC 1F08 0680 090 55594 4 F08 0694 04 9680 00 98 8 F08 0715 06 2480 58 98 8 ABC 2 F08 0722 892 9969 39 199 4 May include a short comparison between batches Also analysis some deviations among the current batches or between the current batches and the previous batch Batch history or tracing tree 是将从产品向上追溯 中途经历的中间体 原料一直到最 初始原料做成一个树状图 表明原料和中间体及产品的因果关系 图中需包括各物质 的批号 投料日期 净重 纯度或含量 2Y CHEM LTD Document Code 2020 3 314 6 Compound 1 Compound 2 Compound 3 Compound 4 Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay Lot yyy Date Net Weight Purity Assay aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg aaa kg IPC summary 总结相关中控数据及信息 List if the customer required If not list separately for QA achievement Steps Batch No IPC No SpecificationResult TLC Eluent or HPLC GC method No IPC 1 1NUC 0 5 5 DCM methanol 8 1 F08 069 IPC 1 2LOD 2 0 02 IPC 1 1NUC 0 5 5 DCM methanol 8 1 F08 071 IPC 1 2LOD 2 0 02 ABC 2 F08 072IPC 1 1NUC 0 5 5 DCM methanol 8 1 2Y CHEM LTD Document Code 2020 3 315 6 IPC 1 2LOD 2 0 02 Intermediate purity summary Steps Batch No Purity Specification ResultImpurities F08 06998 8 F08 07198 8 ABC 2 F08 072 98 0 99 4 Critical and key parameters Such as Equ temperature reaction time pH water content charge order impurities purification method etc 当量 温度 反应时间 pH 水分含量 投料顺序 杂质 纯化方法等 StepparameterRecommendedRemarksNoteRef ABC 2Reaction temperature Reflux 65 C The reaction should be run at reflux If not the reaction will become very slowly Important paramete r YXG 1 81 Others such as stability test results other special test results 6 生产后要点总结生产后要点总结 Discussions 英文版报告建议此部分采用中文 方便记录下关键信息 分步总结 把生产过程中观察到 怎样能做的更好的方面记录下来 哪些方面还需要小试 哪些方面还值得研究等等 内容 不限 7 Data summary of all COA 3 5 批中试或者放大生产项目 如果没有三批 有几批写几批 需要将关键原始数据摘 出来列表总结 列表的时候严格按照 COA 的每个要求一一对应 项目 items 规格 Specs 批号 Lot No 批号 Lot No 批号 Lot No Appearance ID Purity 2Y CHEM LTD Document Code 2020 3 316 6 注意事项 注意事项 1 以上项目没有内容的 以以上项目没有内容