Mediron Plus New

BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
Department: Production Section: Liquid

ISO No. PRD-LIQ / BMO /3/009
PRODUCT: Mediron Plus syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 1 of 7
19.04.2016 19-04-2021
WRITTEN BY REVIEW BY CHECKED BY APPROVED BY AUTHORIZED BY
Sign. __________ Sign. ________________ Sign. ________________ Sign. ________________ Sign. ________________
Name. waseem shah Name. Mushtaq Ahmed_ Name. Amber khan_____ Name. Irfan Wahid___ Name. Fawad Ishtiaq_________
Desig. Section Incharge Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___
Batch No: Product Code: MR Shelf Life: 02 Years Batch Size: 1200Lts.
Act. Issued Verified

S. No Ingredients Std. Qty Factor Addn Unit Q.C. No
Qty By By
1 Thiamine HCl 0.288 Kg
2 Pyridoxine HCl 0.576 Kg
3 Ferric ammonium citrate 11.340 Kg
4 Folic acid 0.144 Kg
5 Nicotinamide 2.880 Kg
6 Sugar 360.00 Kg
7 Liquid Glucose 480.000 Kg
8 Methyl paraben 1.200 Kg
9 Propyl paraben 0.240 Kg
10 Sodium citrate 0.360 Kg
11 Benzoic acid 2.400 Kg
12 Caramel color 7.380 Kg
13 Chocolate flavor 1.200 Lt
14 Vanilla flavor 0.200 Lt
15 Neotame 0.020 Kg
16 Sodium chloride 4.350 Kg
MANUFACTURING FORMULA
Note: Quantity of active materials to be adjusted on the basis of its potency.
Section Inchage QC Manager RMS Inchage Date


SOP No.: NEW
19.04.2016 19-04-2021
CLEANING RECORD
NAME OF EQUIPMENT
EQUIPMENT NUMBER
PRODUCT LAST
MANUFACTURED
BATCH NO.
CLEANED BY
DATE
VERIFIED BY
DATE

SOP No.: NEW
19.04.2016 19-04-2021
MANUFACTURING INSTRUCTIONS
PRECAUTIONS:
1. PROCESS WORKER MUST WEAR FACEMASK,AND GLOVE.

2. ALL EQUIPMENTS MUST BE CLEANED AND PROPERLY LABELED.
3. PROTECT THE PRODUCT FROM EXPOSURE TO LIGHT.
PROCEDURES.
VERIFIED
STEP PARAMETER
OPERATION PERFORMED BY
NO. CHECKED DATE
BY
1 Take
200 liters D.I. water in SS tank. Temperature
Heat up to 75ºC to 80 ºC .Add to it
1.200 kg Methylparaben,
0.240 kg Propylparaben,
2.400 kg Benzoic acid,Neotame Time On

0.020kg.
200kg Sugar and mix till completely

dissolved. Time off
Note
Temperature should not exceed

above 80ºC.Cool the syrup to 50C.
2 Add into the another tank Volume


SOP No.: NEW
19.04.2016 19-04-2021
480.0kg Liquid glucose,
Transfer the syrup base of step 1 Temperature

and mix for 30 minutes and check
the volume.
Time ON
Time OFF
3 Dissolve in 5 litres D.I water
Nicotinamide_______________kg
Volume
Folic acid ____________Kg
Sodium citrate 0.360 kg, add this Time ON

solution to step 2 and mix and mix
for 10 minutes.
Time OFF

SOP No.: NEW
19.04.2016 19-04-2021
VERIFIED
STEP PARAMETER
OPERATION PERFORMED BY
NO. CHECKED DATE
BY
4 Dissolve in 5 lts. D.I water

_________ kg Thiamine Hcl, Volume
__________kg Pyridoxine Hcl,
Add this solution to step 2 and mix
and mix for 10 minutes. Time ON
Time OFF
5 Dissolve in D.I water
___________Ferric ammonium
citrate, 4.350 kg Sodium chloride, Volume
Add to step 2 and mix for 10

minutes. Time ON
Time OFF

SOP No.: NEW
19.04.2016 19-04-2021
6 Lastly add to step 2,

Volume
7.380 kg Caramel color,
1.20 liters Chocolate flavor,
0.20 liters Vanilla flavor, Time ON
Make up the volume 1200lts. and
mix for 15 minutes,filter the batch
though filter assembly and intimate
QAD for sampling.
Time OFF
Production Remarks: __________________________________________________________________________________

_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_____________________________________________________________________________________________
DOCUMENT VERIFICATION:
Verified By: _________________________ Authenticated By: _________________________
Section Incharge Manager Prod.
Date: ______________________________
Date: ___________________________________
SUBMISSION OF BATCH HISTORY:

Submit Batch Manufacturing Order to Quality Control for collection of sample and Analysis

SOP No.: NEW
19.04.2016 19-04-2021
B.M.O. SUBMITTED BY: ______________________________ Date :_________________
B.M.O. RECEIVED BY: _______________________________ Date: _________________
Quality Assurance Remarks:____________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_____________________________________________________________________________________________

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BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

Act. Issued Verified

Note: Quantity of active materials to be adjusted on the basis of its potency.

Section Inchage QC Manager RMS Inchage Date

Department: Production Section: Liquid

Department: Production Section: Liquid

1. PROCESS WORKER MUST WEAR FACEMASK,AND GLOVE.

2.400 kg Benzoic acid,Neotame Time On

200kg Sugar and mix till completely

Temperature should not exceed

2 Add into the another tank Volume

Department: Production Section: Liquid

480.0kg Liquid glucose,

Transfer the syrup base of step 1 Temperature

3 Dissolve in 5 litres D.I water

Sodium citrate 0.360 kg, add this Time ON

Department: Production Section: Liquid

4 Dissolve in 5 lts. D.I water

5 Dissolve in D.I water

Add to step 2 and mix for 10

Department: Production Section: Liquid

6 Lastly add to step 2,

Production Remarks: __________________________________________________________________________________

Verified By: _________________________ Authenticated By: _________________________

Section Incharge Manager Prod.

SUBMISSION OF BATCH HISTORY:

Department: Production Section: Liquid

B.M.O. SUBMITTED BY: ______________________________ Date :_________________

B.M.O. RECEIVED BY: _______________________________ Date: _________________

Quality Assurance Remarks:____________________________________________________________________________

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Verified By: _ Authenticated By: _

B.M.O. SUBMITTED BY: ______________ Date :_

B.M.O. RECEIVED BY: _______________ Date: _