批记录.docx

1、批记录批记录Grnenthal Pharmaceutical (China) Co., Ltd. MANUFACTURING RECORD DOCUMENT No. 文件号 COVER SHEET A1/22 MPD-IJP-001-R01 生产指令 PRODUCT NAME/品名 BATCH SIZE/批重量 MATERIAL CODE/代号 STRENGTH/规格 BATCH NO./批号 Tramadol hydrochloride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 PLANNING MANAGER

2、/计划主管签名: DATE /日期: PRODUCTION MANAGER/生产主管接收: DATE/日期: Tramadol hydrochloride MASTER FORMULA DOCUMENT NO. Capsules M0201-02 工艺规程 文件号 盐酸曲马多胶囊 MASTER DOCUMENT/文件 SIGNED BY/签名 DATE/日期 ORIGINATED BY 起草人 HEAD OF QUALITY CONTROL CHECK 质量部经理审核 HEAD OF PRODUCTION CHECK 生产部经理审核 APPROVED BY 批准使用人 VALID DATE Y

3、/年 M/月 D/日 生效日期 Grnenthal Pharmaceutical (China) Co., Ltd. DOCUMENT No. MANUFACTURING RECORD 文件号 A2/22 230201-02 CONTENT/目录 PRODUCT NAME/品名 BATCH SIZE/批重量 MATERIAL CODE/代号 STRENGTH/规格 BATCH NO./批号 Tramadol hydrochloride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 PAGE DOCUMENT NAME

4、/文件名 页号 1 COVER SHEET/生产指令 2 CONTENT/目录 3 RAW MATERIALS CHECK BEFORE DISPENSING/配料前原辅料检查 4 PRE-START CHECK FOR DISPENSING/配料前检查 5 RAW MATERIALS DISPENSING/配料 6 LINE CLEARANCE AFTER DISPENSING/配料工序清场记录 7 PRE-START CHECK FOR BLENDING/混合前检查 8 RAW MATERIALS CHECK BEFORE BLENDING/混合前原辅料检查 9 BLENDING/混合 1

5、0 LINE CLEARANCE AFTER BLENDING/混合工序清场记录 11 PRE-START CHECK FOR CAPSULE FILLING/胶囊填充前检查 12 CAPSULE FILLING/胶囊填充 13-14 CAPSULE WEIGHT CHECK /胶囊粒重检查 15-19 IPC RECORD OF FILLED CAPSULE WEIGHT AND APPERANCE/胶囊粒重、外观IPC检查 20 IPC RECORD FOR DISINTEGRATION /胶囊崩解时限IPC检查 21 LINE CLEARANCE AFTER CAPSULE FILLIN

6、G/胶囊填充工序清场记录 22 JUDGEMENT OF MANUFACTURING AND IPC/生产和IPC的评价 Documentation checked in each step against work result on site by production manager. 每一步生产结束后，生产主管在工作现场检查生产记录和工作结果。 Head of production and head of quality assurance check this record after manufacturing work is completed. 生产经理和质量经理在生产结束后检

7、查本记录。 NOTE/备注: Grnenthal Pharmaceutical (China) Co., Ltd. MANUFACTURING RECORD DOCUMENT No. 文件号 RAW MATERIALS CHECK BEFORE DISPENSING A3/22 230201-02 配料前原辅料检查 PRODUCT NAME/品名 BATCH SIZE/批重量 MATERIAL CODE/代号 STRENGTH/规格 批号 BATCH NO./Tramadol hydrochloride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp

8、. 900,000 caps/粒 MATERIAL CODE MATERIAL NAME TYPE STANDARD QTY QTY STAGING BATCH NO. COA NO. CHECKED BY 代号 物料名称 规格 批用量 暂存量(kg) 批号 报告书编号 检查人 Tramadol Hydrochloride Ground 100008 45.000 kg 盐酸曲马多 粒状 Microcrystalline Cellulos 200022 PH102 25.200 kg 微晶纤维素 Sodium Starch Glycollate 200020 18.000 kg 羧甲基淀粉钠

9、Magnesium Stearate 200004 4.500 kg 硬脂酸镁 Colloidal silicon dioxide 200003 1.800 kg 微粉硅胶 Empty Capsules 900,000 200013 4# 空心胶囊 pieces/粒 NOTE/备注: PRODUCTION MANAGER/生产主管 DATE/日期 Grnenthal Pharmaceutical (China) Co., Ltd. MANUFACTURING RECORD DOCUMENT No. 文件号 PRE-START CHECK FOR DISPENSING A4/22 230201-

10、02 配料前检查 PRODUCT NAME/品名 BATCH SIZE/批重量 MATERIAL CODE/代号 STRENGTH/规格BATCH NO./批号 Tramadol hydrochloride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 Checked by INSTRUCTIONS/操作指导 检查人 Start date and time/开始时间: y/年 m/月 d/日 h/时 m/分 Temperature/温度: _ Relative Humidity/相对湿度: _ (1) Previou

11、s batch handled in dispensing /上批产品 Name of product/品名: Batch No./批号: (2) All materials and documents related to the previous batch have been removed. 所有与上批产品有关的物料和文件已清除。 (3) The area and equipment have been cleaned by approved procedures and the line clearance certificate is available. 设备和场地已按批准程序清

12、洁，并有上批的清场合格证。 LINE CLEARANCE CERTIFICATE 贴清场合格证处 (4) All materials necessary for dispensing are released and available for use. 本次生产所需物料有合格状态标签。 Finish date and time/结束时间: y/年 m/月 d/日 h/时 m/分 Protective mask must be worn during dispensing. 配料过程须戴好防尘口罩。 NOTE/备注: PRODUCTION MANAGER/生产主管 DATE/日期 Grnent

13、hal Pharmaceutical (China) Co., Ltd. MANUFACTURING RECORD DOCUMENT No. 文件号 RAW MATERIALS DISPENSING A5/22 230201-02 配料 PRODUCT NAME/品名 BATCH SIZE/批重量 MATERIAL CODE/代号 STRENGTH/规格BATCH NO./批号 Tramadol hydrochloride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 Actual Qty Batch No. Ope

14、rator Checked by INSTRUCTIONS/操作指导 实际量(kg) 批号 操作者 复核人 Start date and time/开始配料时间: y/年 m/月 d/日 h/时 m/分 (1) According to the dispensing order bellow, dispense raw materials to double decks plastic bags. 参照如下的配料指令称取原辅料至双层塑料袋中扎好口。 _ 100008 Tramadol Hydrochloride/盐酸曲马多 45.000kg _ _ _ 200022 Microcrystall

15、ine Cellulose /微晶纤维素 25.200kg 200020 Sodium Starch Glycollate/羧甲基淀粉钠 18.000kg 200004 Magnesium Stearate/硬脂酸镁 4.500kg _ _ _ 200003 Colloidal silicon dioxide/微粉硅胶 1.800kg _ _ _ (2) Put labels on each dispensed material indicating material code, name, and batch No. and quantity. Put the materials in dr

16、ums. Label the drums and put them on pallet. 在每种原辅料上贴好配料标签，标明原辅料代号、品名和批号及产品 代号、品名、批号和数量。将各原辅料装在大桶中，挂上中间产品状 态标签，放在托盘上。 (3) Then make a record on related material card in staging area. 在暂存区各自货卡上登记。 (4) Seal the remained materials and fill the quantity from which the previous quantity subtract the weig

17、hed quantity on the label. Return them to the raw materials staging area. 把剩下的原辅料重新封好，将原重量减去已称去的重量所得的重量填 写在标签上，并将其退回原辅料暂存区。 (5) Transfer the dispensed materials to room No. 2.21. 将已称量好的原辅料送至2.21房间摆放整齐。 (6) Inform the production manager to check the dispensed materials. 通知生产主管检查配好的原辅料。 Finish date an

18、d time/结束时间: y/年 m/月 d/日 h/时 m/分 NOTE/备注: PRODUCTION MANAGER/生产主管 DATE/日期 Grnenthal Pharmaceutical (China) Co., Ltd. MANUFACTURING RECORD DOCUMENT No. 文件号 LINE CLEARANCE AFTER DISPENSING A6/22 230201-02 配料工序清场记录 PRODUCT NAME/品名 BATCH SIZE/批量 MATERIAL CODE/代号 STRENGTH/规格 BATCH NO./批号 Tramadol hydroch

19、loride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 Operator Checked by INSTRUCTIONS/操作指导 操作者 检查人 Start date and time/开始时间: y/年 m/月 d/日 h/时 m/分 (1) All materials related to this batch of product have been removed. 与本批产品有关的物料已清理干净。 (2) Floor, walls, door, window and table have been c

20、leaned. 地面、台面、墙面、门窗等已清洁干净。 (3) All equipment, containers and tools have been cleaned and the status signs of equipment are correct. 设备、容器、工具等已清洁干净，设备有正确清洁状态标志。 (4) Air outlet and filter have been cleaned. 回风口及回风口过滤器已清洁干净。 (5) Line clearance certificate has been filled. 清场合格证已填写。 Line clearance certi

21、ficate(Original) 清场合格证 (正本) Section/岗位: Equipment/设备: Room no./房间号: Material code/物料代号: Material name/物料名称: Batch no./批号: Operated by/清场人: Date/日期: Inspected and approved by/检查批准人: Date/日期: Finish date and time/结束时间: y/年 m/月 d/日 h/时 m/分 In case of working with the same product in next dispensing, on

22、ly clear away dispensed materials and relevant documents from previous batch. 如下批产品相同，则只需清走已配好的物料和本批有关文件即可。 NOTE/备注: PRODUCTION MANAGER/生产主管 DATE/日期 Grnenthal Pharmaceutical (China) Co., Ltd. MANUFACTURING RECORD DOCUMENT No. 文件号 PRE-START CHECK FOR BLENDING A7/22 230201-02 混合前检查 PRODUCT NAME/品名 BAT

23、CH SIZE/批量 MATERIAL CODE/代号 STRENGTH/规格 BATCH NO./批号 Tramadol hydrochloride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 Checked by INSTRUCTIONS/操作指导 检查人 Start date and time/开始时间: y/年 m/月 d/日 h/时 m/分 Temperature/温度: _ Relative Humidity/相对湿度: _ (1) Previous batch handled in blending

24、/上批产品 Name of product/品名: Batch No./批号: (2) All materials and documents related to the previous batch have been removed. 所有与上批产品有关的物料和文件已清除。 (3) The area and equipment have been cleaned by approved procedures and the line clearance certificate is available. 设备和场地已按批准程序清洁，并有上批的清场合格证。 LINE CLEARANCE C

25、ERTIFICATE 贴清场合格证处 (4) All materials necessary for blending are released and available for use. 本次生产所需物料有合格状态标签。 Finish date and time/结束时间: y/年 m/月 d/日 h/时 m/分 Protective mask must be worn during blending. 混合过程须戴好防尘口罩。 NOTE/备注: PRODUCTION MANAGER/生产主管 DATE/日期 Grnenthal Pharmaceutical (China) Co., Lt

26、d. MANUFACTURING RECORD DOCUMENT No. 文件号 RAW MATERIALS CHECK BEFORE BLENDING A8/22 230201-02 混合前原辅料检查 PRODUCT NAME/品名 BATCH SIZE/批量 MATERIAL CODE/代号 STRENGTH/规格 BATCH NO./批号 Tramadol hydrochloride Capsules 129.60 kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 Before blending check the label on the m

27、aterials. Be sure that the material name, type, material code, batch No. and quantity are indicated. 混合前先核对物料上的标签，确认物料名称、规格、代号、批号和重量。 MATERIAL CODE TYPE BATCH NO. STD QTY ACTUAL QTY CHECKED BY MATERIAL NAME 物料号 物料名称 规格 批号 批用量(kg) 实际量(kg) 检查人 Tramadol Hydrochloride Ground 100008 45.000 盐酸曲马多 粒状 Micro

28、crystalline Cellulos 200022 PH102 25.200 微晶纤维素 Sodium Starch Glycollate 200020 _ 18.000 羧甲基淀粉钠 Magnesium Stearate 200004 _ 4.500 硬脂酸镁 Colloidal silicon dioxide 200003 _ 1.800 微粉硅胶 94.500 Total Dry Weight/总重量: NOTE/备注: PRODUCTION MANAGER/生产主管 DATE/日期 Grnenthal Pharmaceutical (China) Co., Ltd. MANUFAC

29、TURING RECORD DOCUMENT No. 文件号 BLENDING A9/22 230201-02 混合 PRODUCT NAME/品名 BATCH SIZE/批重量 MATERIAL CODE/代号 STRENGTH/规格 BATCH NO./批号 Tramadol hydrochloride Capsules 129.60kg 500002 50mg 盐酸曲马多胶囊 corresp. 900,000 caps/粒 Operator Checked by INSTRUCTIONS/操作指导 操作者 复核人 Starting time and date/开始时间: y/年 m/月

30、d/日 h/时 m/分 (1) Pre-mix/预混合 Put Tramadol Hydrochloride, microcrystalline cellulose, Sodium starch glycol late, Magnesium Stearate and Colloidal silicon dioxide into the Bohle container MCG300. 将盐酸曲马多、微晶纤维素、羧甲基淀粉钠、硬脂酸镁和微粉硅胶加入MCG300 容器中。 Mix the materials with the Bohle PM1000 container mixer for 10 m

31、inutes at 6rpm. 用Bohle PM1000容器混合机以6rpm速度混合10分钟。 From To_(Hour: Min) At rpm (2) Sieving/过筛 Sieve the material with round hole sieve 0.8mm Bohle Turbo sieve BTS200 at 300rpm into the MCG300 container. 将上述物料在300rpm的转速下过孔径0.8mm的BTS200的Bohle Turbo 孔筛，装入MCG300容器。 (3) Final mix/终混 Mix the sieved materials with the Bohle PM1000 container mixer for 40 minutes at 6rpm. 将过好筛的物料用Bohle PM1000容器混合机在6rpm的速度下混合40分钟。 Minutes/分钟 rpm (4) Put label on the container after final mix and transfer the container to staging area (material code 400003). 混合好后在