英文 原料药批生产记录 模板
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
BATCH PRODUCTION RECORD
The following code has been given to the finished product.
Revision level:
Reasons for Revision:
INPUT DETAILS
Product Name: Flunixin meglumine Doc No:
Batch No: Stage: Ⅰ
PRODUCT OUTPUT DETAILS
Out put weight/ Output Molecule mass Actual yield ratio calculation: Yield ratio = -------------------------------------------------- Input weight / Input Molecule mass Calculated by Verified by
Product Name: Flunixin meglumine Doc No: Batch No: Stage: Ⅰ
Op. No Operation Date Time (hrs) Remarks Done
by
Checked
by
From To Duration
01 Make sure that R2201 is clean and
dry
02 Charge 98kg of purified water , 53kg
of MA , 38.7kg of CA , and 3.67kg
of TS into R2201
03 Start agitation and keep for
15~20minutes
04 Heat to reflux and maintain the reflux
for 2 hours at 10±5℃
05 Prepare 36% potassium hydroxide
solution by adding 25.2kg of
potassium hydroxide and
44.8kg of purified water
06 Add 30.5kg of hydrochloric acid and
9.5kg of purified water to prepare
another 23% hydrochloric acid
solution
07 Then charge excess 4 kg of purified
water to R2201
08 Adjust the reaction mass at pH=9
by dropping 36% potassium
hydroxide solution
09 Cool the temperature below 10℃
and recheck whether pH is still at
9～10, if not , add 36% potassium
hydroxide further to correct it
10 Make sure that ST2202 is dry and
clean
11 Centrifuge the mass from R2201 and
wash the wet cake and R2201 with
100kg of purified water (clean the
R2201 as per procedure specified in
Page No of)
12 Spin dry for 40~50minutes and
introduce mother liquid back R2201
Note: Shift in–charge should cross check the S. No:and shall sign in ‘checked by’ column.
BATCH PRODUCTION RECORD
Product Name: Flunixin meglumine Doc No: Batch No: Stage: Ⅰ
ANALYTICAL DATA RECORD
、
BATCH PRODUCTION RECORD
Product Name: Flunixin meglumine Doc No: Batch No: Stage: Ⅰ
Deviation Record
1) Deviations in Operation :
2) Deviations in Yield :
Remarks:
Production
BATCH PRODUCTION RECORD
Product Name:Flunixin meglumine Doc No: Batch No: Stage: Ⅰ
Temperature Sheet
BATCH PRODUCTION RECORD
Product Name:Flunixin meglumine Doc No: Batch No: Stage: Ⅰ
WEIGHING RECORD
INPUTS
EQUIPMENT BATCH TO BATCH CLEANING PROCEDURE
Product Name: Flunixin meglumine Doc No:
Batch No: Stage: Ⅰ
Ref. No :
Operation No. :EQ. ID No.: RE402
Operation no: (visual observation) should be done by shift in charge.