PRODUCT: Medfen 100 MG / 5 ML (Ibuprofen U.S.P) : Potency Overage

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

ISO No. PRD-LIQ / BMO /307
PRODUCT: Medfen 100 mg / 5 ml
( Ibuprofen U.S.P ) Supercedes date: May, 2007
ISSUE DATE: To REVISED ON: Revision No: 02 Page No: 1 of 7
28-10-2016 28-10-2021
WRITTEN BY: REVIEW BY: CHECKED BY: APPROVED BY: AUTHORIZED BY:
Sign. ___________________ Sign. ____________________ Sign. ____________________ Sign. ____________________ Sign. _____________________
Name. Waseem Shah______ Name. Mushtaq Ahmed______ Name. Javed Iqbal_________ Name. Irfan Wahid__________ Name. Fawad Ishtiaq_________
Desig.Section Incharge ____ Desig. Prod. Manager_______ Desig. QA Manager________ Desig. QC Manager_________ Desig. Prod.director__________
Batch No: Product Code: MF Batch Size: 1000lts. Shelf Life: 03 Years
MANUFACTURING FORMULA
Potency Overage
S. No Ingredients mg/5ml Std. Qty Act. Qty Unit Q.C. No Issued By Verified By
Included
1. *Ibuprofen U.S.P 100 21.000 05% Kg.

2. Sugar 1000.000 200.000 Kg.
3. Methylparaben 5.000 1.000 Kg
4. Propylparaben 1.650 0.330 Kg.
5. Citric acid (Monohydrate) 4.200 0.840 Kg.
6. Vee Gum 15.000 3.000 Kg
7. Sorbitol 70% 230.000 46.000 Kg.
8. Xanthan Gum 19.200 3.840 Kg.
9. Tween 80 1.000 0.200 Kg.
10. Glycerine 83.400 16.680 Kg.
11. Sodium Saccharin 4.000 0.800 Kg.
12. Aerosil 200 1.700 0.340 Kg.
13. Colour Orange 1.250 0.250 Kg.
14. Flavour Orange 2.800 0.560 Lt.
15. D.I Water QS Lt.
* Quantity of Active Ingredient to be adjusted on the basis of its Factor
Raised By Checked By Verified By Received By
Section incharge Production Manager QC Manager RMS


28-10-2016 28-10-2021
CLEANING RECORD
NAME OF EQUIPMENT
PRODUCT LAST
MANUFACTURED
BATCH NO.
CLEANED BY
DATE
__________ ___________
Section incharge: Verified by QAI
LINE CLEARANCE

28-10-2016 28-10-2021
PREVIOUS PRODUCT
Product
B. No
Batch size
Date of completion
Time of completion
Traces of last product
Remarks
CURRENT PRODUCT
Product
B. No
Batch size
Machine status
Manufacturing date
Expiry date
Retail price
Remarks
__________________ __________________
Printing Officer QA Inspector
Date: ______ Time: ________ Date: _______ Time: ________
MANUFACTURING INSTRUCTIONS
PRECAUTIONS:

28-10-2016 28-10-2021
1. PROCESS WORKERS MUST WEAR FACEMASK, GLOVES AND GMP / SAFETY SHOES.
2. ALL EQUIPMENTS MUST BE CLEANED AND PROPERLY LABELED.
3. PROTECT THE PRODUCT FROM EXPOSURE TO LIGHT.
PROCEDURE:
STEP PARAMETER PERFORMED VERIFIED

OPERATION DATE
NO. CHECKED BY BY
1. Base Preparation Tank No
Take
400.000 Liters D.I. water in SS tank.
Heat up to 75ºC to 80 ºC. Temperature
Add into it Time ON
1.000 Kg Methylparaben
0.330 Kg Propylparaben and
200.0 Kg Sugar and Time OFF
Note: Temperature should not exceed

above 80ºC. Temperature
Cool the syrup 45ºC to 50ºC.
2. Transfer the syrup base to batch Volume

manufacturing tank through Nylon/Teflon
cloth

NO. OPERATION DATE
CHECKED BY BY

28-10-2016 28-10-2021
3. Soaking Time ON
In separate bucket take 10 liter of D.I

Time OFF
3.840 Kg Xanthan Gum
3.000 Kg Vee Gum
Mix for 30 minutes

Time ON
Add to step # 2 with continuous stirring
Time OFF
4. Paste preparation Time ON
Add ___________ Kg Ibuprofen with
46.000 Kg Sorbitol 70% Time OFF
16.680 Kg Glycerin
Volume
0.200 Kg Tween-80
Mix for 20 minutes and add it in the step #

02

NO. OPERATION DATE
CHECKED BY BY

28-10-2016 28-10-2021
5. Dissolve separately in D.I. water Time ON
0.340 Kg Aerosil-200 and

Time OFF
0.800 Kg Sodium Saccharine
Add into step# 02 and mix for 10 minutes Volume
6. Dissolve in _______D.I. water Time ON
0.840 Kg Citric acid and Time OFF
Add it into step # 02

7. Dissolve in ______D.I. water Time ON
0.250 Kg Orange colour and Time OFF
Add it into step # 02

8. Finally add Volume
0.560 liter Flavour Orange
Make up the volume to 1000 liters with D.I. Time ON
water
Mix for 25 minutes Time OFF
Note:
Time ON
Keep the suspension for overnight to
remove the entrapped air and again make
the volume (if required) with D.I. water Time OFF
Mix for 15 minutes.
OPERATION DATE
NO. CHECKED BY BY

28-10-2016 28-10-2021
9. Intimate QA department to take sample Sample taken by

and Submit the sample for analysis
PRODUCTION REMARKS:
_______________________________________________________________________________________________
_______________________________________________________________________________________________
DOCUMENT VERIFICATION:
Verified By: _________________________ Authenticated ________________________

(Section Incharge) (Manager Production)
Date: _____________________________ Date: _______________________________
SUBMISSION OF BMO:
Finally Submit Batch Manufacturing Order to Quality Assurance department.
BMO SUBMITTED BY: _______________________ Date: _________________________
BMO RECEIVED BY: ________________________ Date: _________________________
QUALITY ASSURANCE REMARKS:
_______________________________________________________________________________________________
_______________________________________________________________________________________________

PRODUCT: Medfen 100 MG / 5 ML (Ibuprofen U.S.P) : Potency Overage

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BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid syrup

1. *Ibuprofen U.S.P 100 21.000 05% Kg.

Raised By Checked By Verified By Received By

Section incharge Production Manager QC Manager RMS

Department: Production Section: liquid syrup

Department: Production Section: liquid syrup

Department: Production Section: liquid syrup

STEP PARAMETER PERFORMED VERIFIED

Add into it Time ON

Note: Temperature should not exceed

Cool the syrup 45ºC to 50ºC.

2. Transfer the syrup base to batch Volume

STEP PARAMETER PERFORMED VERIFIED

Department: Production Section: liquid syrup

In separate bucket take 10 liter of D.I

Mix for 30 minutes

4. Paste preparation Time ON

Add ___________ Kg Ibuprofen with

46.000 Kg Sorbitol 70% Time OFF

Mix for 20 minutes and add it in the step #

STEP PARAMETER PERFORMED VERIFIED

Department: Production Section: liquid syrup

5. Dissolve separately in D.I. water Time ON

0.340 Kg Aerosil-200 and

Add into step# 02 and mix for 10 minutes Volume

6. Dissolve in _______D.I. water Time ON

0.840 Kg Citric acid and Time OFF

Add it into step # 02

0.250 Kg Orange colour and Time OFF

Add it into step # 02

Department: Production Section: liquid syrup

9. Intimate QA department to take sample Sample taken by

Verified By: _________________________ Authenticated ________________________

Finally Submit Batch Manufacturing Order to Quality Assurance department.

BMO SUBMITTED BY: _______________________ Date: _________________________

BMO RECEIVED BY: ________________________ Date: _________________________

QUALITY ASSURANCE REMARKS:

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Verified By: _ Authenticated

BMO SUBMITTED BY: _ Date: ___

BMO RECEIVED BY: Date: _