Mega Iron Syrup (Elemental Iron-50 MG) : Product

BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
Department: Production Section: liquid
PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320
( Elemental Iron-50 mg) Supercedes date:

SOP No.:
NEW
NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 1 of 7
12.04.2016 12-04-2021
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: MI Batch Size:600Ltrs Shelf Life:03 Years
DATE BATCH STARTED DATE BATCH COMPLETED
S. Poten Overage Issued Verified

Ingredients Std. Qty Act. Qty Unit Lot No
# cy include By By
Iron Polymaltose
1 22.073 Kg 3% Kg
Complex
2 Methyl Paraben 1.20kg Kg
3 Propyl Paaben 0.020 Kg
4 Citric Acid (Mono) 0.70 kg Kg
5 Sorbitol 70% 100.00 kg Kg
6 Sugar Granular 90.00 kg Kg
7 Chocolate flavor 0.750Lt Lt

SOP No.:
NEW
NEW
12.04.2016 12-04-2021
8 Vanilla flavor 0.750Lt Lt

9 Coconut Flavor 0.750Lt Lt
10 Neotame 0.01125 Kg
0
Note: * Quantity of Iron Polymaltose Complex is calculated considering the assay of the material 28%.
Actual quantity to be
Calculated as per the actual potency (as is) given by Q.C as follows:-
Actual Quantity of Iron Polymaltose Complex = 22.073 x 28 = ____________kg
MATERIAL RET URN TO RMS: Potency
S. No Material Quantity lot No. Returned By Received By Remarks
Raised By Verified By Received By Required Date/Time
Section Incharge QC Manager RMS Date:


SOP No.:
NEW
NEW
12.04.2016 12-04-2021
CLEANING RECORD
NAME OF EQUIPMENT
EQUIPMENT NUMBER
PRODUCT LAST
MANUFACTURED
BATCH NO.
CLEANED BY
DATE
VERIFIED BY
DATE
Section In charge: ________________ Checked By QAI: __________________
Date:_________________ Date:__________________

SOP No.:
NEW
NEW
12.04.2016 12-04-2021
MANUFACTURING INSTRUCTIONS
PRECAUTIONS:
1. PROCESS WORKER MUST WEAR FACE MASK, AND GLOVE.

2. ALL EQUIPMENTS MUST BE CLEANED AND PROPERLY LABELED.
3. PROTECT THE PRODUCT FROM EXPOSURE TO LIGHT.
PROCEDURES.
STEP PARAMETER VERIFIED

OPERATION PERFORMED BY
NO. CHECKED DATE
BY
1 Take Temperature
200 liters D.I. water in SS tank.
Heat up to 75ºC to 80 ºC.
Add to it
Time ON
01.20 kg Methyl paraben,
0.020 kg Propyl paraben,
90.00 kg Sugar and 0.011225kg

Neotame
Time OFF
Note: Temperature should not
exceed above 80ºC.
Cool the syrup to 50ºC.


SOP No.:
NEW
NEW
12.04.2016 12-04-2021

OPERATION PERFORMED BY
NO. CHECKED DATE
BY
2 Cool the base to 40 – 45ºC Check Volume
the volume and mix.
Add into the main tank

Temperature
Citric Acid (Mono) 0.70 kg
Sorbitol70% 100.00 kg
Time ON
Time OFF
3 Dissolve __________kg Iron

Polymaltose Complex in 50 lts D.I
water and add this solution to step Volume
2 and mix for 20 min.
Time ON
Time OFF

OPERATION PERFORMED BY DATE
NO. CHECKED BY

SOP No.:
NEW
NEW
12.04.2016 12-04-2021
4 Lastly add to step 2, Volume

0.750 liters Coconut flavor,
0.750liters Chocolate flavor,
0.750 liters Vanilla flavor, Time ON
Make up the volume up to 600lts
and mix for 45 min
Time OFF
5 Intimation for Sampling
Send Analysis request to QAD for Qty _____Lts

collection and Analysis of sample.

SOP No.:
NEW
NEW
12.04.2016 12-04-2021
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
B.M.O. submitted by: ______________________________
B.M.O. received by: _______________________________
Quality Assurance Remarks:

____________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________

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BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320

( Elemental Iron-50 mg) Supercedes date:

Batch No: Product Code: MI Batch Size:600Ltrs Shelf Life:03 Years

DATE BATCH STARTED DATE BATCH COMPLETED

S. Poten Overage Issued Verified

Department: Production Section: liquid

PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320

( Elemental Iron-50 mg) Supercedes date:

Batch No: Product Code: MI Batch Size:600Ltrs Shelf Life:03 Years

8 Vanilla flavor 0.750Lt Lt

Raised By Verified By Received By Required Date/Time

Section Incharge QC Manager RMS Date:

Department: Production Section: liquid

PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320

( Elemental Iron-50 mg) Supercedes date:

Batch No: Product Code: MI Batch Size:600Ltrs Shelf Life:03 Years

Section In charge: ________________ Checked By QAI: __________________

Department: Production Section: liquid

PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320

( Elemental Iron-50 mg) Supercedes date:

Batch No: Product Code: MI Batch Size:600Ltrs Shelf Life:03 Years

1. PROCESS WORKER MUST WEAR FACE MASK, AND GLOVE.

STEP PARAMETER VERIFIED

0.020 kg Propyl paraben,

90.00 kg Sugar and 0.011225kg

Cool the syrup to 50ºC.

Department: Production Section: liquid

PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320

( Elemental Iron-50 mg) Supercedes date:

Batch No: Product Code: MI Batch Size:600Ltrs Shelf Life:03 Years

STEP PARAMETER VERIFIED

Add into the main tank

3 Dissolve __________kg Iron

STEP PARAMETER VERIFIED

Department: Production Section: liquid

PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320

( Elemental Iron-50 mg) Supercedes date:

Batch No: Product Code: MI Batch Size:600Ltrs Shelf Life:03 Years

4 Lastly add to step 2, Volume

5 Intimation for Sampling

Send Analysis request to QAD for Qty _____Lts

Department: Production Section: liquid

PRODUCT: Mega Iron Syrup ISO No. PRD-liq/3/320

( Elemental Iron-50 mg) Supercedes date:

Batch No: Product Code: MI Batch Size:600Ltrs Shelf Life:03 Years

Verified By: ______________ Authenticated By: _______________

B.M.O. submitted by: ______________________________

B.M.O. received by: _______________________________

Quality Assurance Remarks:

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Section In charge: Checked By QAI: __

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