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BATCH MANUFACTURING RECORD

Product: Paracetamol 500 Generic Name: NA
BMR No.: MPL/PG/BMR/PQ/00 B. No.: Page No. 1 of 6
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CONFIDENTIAL–NOT TO BE REPRODUCED WITHOUT PERMISSION

Mfg. Date Exp. Date

Market: Dummy
Storage Condition: Keep in a cool dry place
Protect from light Shelf Life: NA

Reason for Revision: Mfg. Location: Nalagarh (Block-N2)

Effective date: Review Period: NA

BMR Supersedes No.: NIL Product Code: PQ

MMF No. Standard Batch size Recovery added Actual Batch Size
NA 1000.0 ltr NA NA
Reason for Issue: For Performance Qualification of Manufacturing tank

Contents of Batch Manufacturing Record

Sr. No. Process Stage Page No.
1. Dispensing of Materials 2-4
2. Manufacturing Process 5 -6

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production
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BATCH MANUFACTURING RECORD

Product: Paracetamol 500 Generic Name: NA
BMR No.: MPL/PG/BMR/PQ/00 B. No.: Page No. 2 of 6

STAGE 1: DISPENSING
Equipment Name Equipment Code No. Operation SOP No. Cleaning SOP No.
Reverse Laminar Air flow

Dispensing Tools

Area: Dispensing Area

Check the following and take line clearance from QA as per SOP No.: ____
Removal of previous product and batch , Equipment cleanliness , Area cleanliness , Status Labelling
, Environmental condition , Balance calibration record , Equipment log sheets , Pressure
differential of LAF .

Checked by Approved by
(Store) (QA)
Sign & Date

INSTRUCTIONS:
1. Follow gowning procedure for respective area
2. Use hand gloves, Safety goggles (wherever required) and nose mask during dispensing.
3. Dispense approved materials.
4. Dispensing of material is in single lots.
5. Dispensing of Extra Material is in single lot.

Balances used
Stores Production
Balance ID No. Checked by Balance ID No. Checked by

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production
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BATCH MANUFACTURING RECORD

Product: Paracetamol 500 Generic Name: NA
BMR No.: MPL/PG/BMR/PQ/00 B. No.: Page No. 3 of 6

RAW MATERIAL ISSUANCE SHEET (Production copy)

Batch Size: 1000.0 Ltrs Date

S Item Ingredients U Std. Actua Gr Tar Net A.R. Issu Checked *Verified
. Cod O Quantit l oss e wt. NO. ed by By Sign
N e y Quan wt wt. by (Product & Date
M
o (Kg) t--ity (stor ion)
e)
Paracetamol 1.00*
1. Kg
IP
2. Sugar IP Kg
150.00

3. Propylene Kg

glycol IP 10.00

6. Purified q.s. to
water IHS 1000 L

Calculation:

Exact quantity of Paracetamol IP required for a batch in kg is calculated using following formula.

* Quantity of Paracetamol IP (in kg) = 1 x 100 X Batch size

Assay on as such basis 1000

Corrected quantity of Paracetamol IP = kg

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production
 XYZ.com

BATCH MANUFACTURING RECORD

Product: Paracetamol 500 Generic Name: NA
BMR No.: MPL/PG/BMR/PQ/00 B. No.: Page No. 4 of 6

STAGE 2: Line Clearance In Manufacturing Area Date:

Equipment Name Equipment Code No. Operation SOP No.

2000 ltrs sugar dissolving tank
1000 ltrs S S Manufacturing Tank
Basket filter assembly

3000 ltrs S S Holding tank

Filter Press
Put “” if complies and put “x” if does not complies in the check box.

Previous Product: Batch No.:

Check the following and take line clearance from QA as per SOP No. _____________
Removal of previous product and batch , Equipment cleanliness , Area cleanliness ,
Status Labelling , Environmental condition , Balance calibration record , Equipment log
sheets .

Checked by (Production) Approved by (QA)

Sign & Date

INSTRUCTIONS:
Follow these general precautions before starting the manufacturing
1. Ensure all equipments are cleaned and having proper status label.
2. Ensure all gowning of the respective area is followed.
3. Ensure that all SOP’s are followed at all stage of manufacturing.
4. Maintain Raw material and finished product at temperature between 25°C± 2°C.

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production
 XYZ.com

BATCH MANUFACTURING RECORD

Product: Paracetamol 500 Generic Name: NA
BMR No.: MPL/PG/BMR/PQ/00 B. No.: Page No. 5 of 6
STAGE 3: MANUFACTURING PROCESS

● Ensure that all the Raw materials weights are crosschecked before processing.

3.1 SOLUTION PREPARATION Date :

Process:
3.1.1. Take 250.0 L of Purified Water in 2000 ltrs sugar dissolving tank , heat up to 80°C, Add Sucrose
under Continue stirring till total quantity of sucrose dissolves. Boil the syrup for 2 minutes. Cool to room
temp. Filter the syrup through # 100 basket filter to 1000-liter ss vessel equipped with mechanical stirrer.

Preparation of Sucrose Syrup

A.R. NO. Quantity Addition & Done by Checked by
Dissolving Time
From To
Purified Water
Sucrose

Temprature of liquid : RPM :

Boiling time : Observations:

Filtration Record
Started at Completed at Done by Checked by

3.1.2. Take 10.0 kg of propylene glycol in ss vessel, warm up to 60°C. Then add paracetamol in it, heat
up to 80°C till get a clear solution. Cool to room temp; Transfer this solution to the syrup of step 3.1.1
under stirring. check for clarity of the solution.

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production
 XYZ.com

BATCH MANUFACTURING RECORD

Product: Paracetamol 500 Generic Name: NA
BMR No.: MPL/PG/BMR/PQ/00 B. No.: Page No. 6 of 6
Record of preparation & Addition of paracetamol
A.R. NO. Quantity Preparation , Done by Checked by
Dissolving &
Addition Time
From To
Propylene glycol
Paracetamol
Temperature of liquid :
Clarity of the solution :

3.1.3 Make up the volume to 1000 liter with Purified Water stir for 30 minutes. Intimate the QC
Department to collect the samples for analysis as per approved Performance qualification protocol.

Volume make up
A.R. Quantity Volume Makeup Stirring Time Done by Checked by
NO. Time
From To From To

3.1.4 Filter the solution through filter pad and take the syrup for bottle filling.
Filtration Record
Date Started at Completed at Done by Checked by

Results:

Sr. No. Location Assay Content %

01 Top
02 Middle
03 Bottom
BMR. Verified by

Head Production ________________ Head QA _____________

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production
 XYZ.com

BATCH MANUFACTURING RECORD

Product: Paracetamol 500 Generic Name: NA
BMR No.: MPL/PG/BMR/PQ/00 B. No.: Page No. 7 of 6
Sign & Date Sign & Date

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production
 Macleods Pharmaceuticals Limited 1
Village Theda, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh
BATCH MANUFACTURING RECORD
Product: Generic Name: NA
BMR No.: B. No.: Page No 1 of 1

Prepared By Checked By Approved By

Sr.Officer QA Officer Sr.Executive Head Head QA
Production QA Production