BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/
PRODUCT: Medgel Suspension
(Sucralfate) Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 1 of 5
21.06.2016 21-06-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: MG Batch Size: 1200 ltrs. Shelf Life: 03 years

DATE BATCH STARTED : DATE BATCH COMPLETED:

MANUFACTURING FORMULA
Act. Issued Verified
S.No Ingredients Std. Qty Factor Addnl Unit Q.C.No By By
Qty
1. *Sucralfate 276.0 Kg.
2. Sodium Benzoate 1.080 Kg.
3. Sodium citrate 1.200 Kg
4. Xanthane Gum 1.680 Kg.
5. Sodium saccharine 1.200 Kg.
6. Flavor Anise 0.480 Lts.
7. Sorbitol 70% 168.0 Kg.
8. Tween-80 1.680 kg
9. D.I water 1200 Lt.
*Quantity of Active ingredients to be adjusted on the basis of potency if less than 99%.

Raised By Reviewed By Verified By: Received By:

Section Incharge Prod.Manager QC Manager RMS

Date/Time: Date/Time: Date/Time: Date/Time:

 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/
PRODUCT: Medgel Suspension
(Sucralfate) Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 2 of 5
21.06.2016 21-06-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: MG Batch Size: 1200 ltrs. Shelf Life: 03 years

CLEANING RECORD

NAME OF EQUIPMENT

EQUIPMENT NUMBER

PRODUCT LAST
MANUFACTURED

BATCH NO.

CLEANED BY

DATE

VERIFIED BY

DATE

Section incharge:--------------------------------------- Verified By Q.A.I----------------------------------------

 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/
PRODUCT: Medgel Suspension
(Sucralfate) Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 3 of 5
21.06.2016 21-06-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: MG Batch Size: 1200 ltrs. Shelf Life: 03 years

MANUFACTURING INSTRUCTIONS
PRECAUTIONS:

1. PROCESS WORKER MUST WEAR FACE MASK AND GLOVES AND GMP/SAFETY SHOES.
2. ALL EQUIPMENTS MUST BE CLEANED AND PROPERLY LABELED.
3. PROTECT THE PRODUCT FROM EXPOSURE TO LIGHT.
PROCEDURE

STEP PARAMETERS PERFORMED

OPERATION VERIFIED BY DATE
NO. CHECKED BY

1 Take Tank No
400 Lt. D.I. water in SS tank.
Heat up to 60º C.
Temperature
Add into it
Time ON
1.680kg Tween-80,mix for 10 minutes,then
add into it 168.0kg Sorbitol

Thooughly mix for at least 15 minutes Time OFF

2 Take 80.00 Lt D.I. water in SS tank . Time ON

1.680 Kg Xanthane Gum ,with overnight

stay if necessary
Time OFF

3 Take 20 lts DI water add into it: Time ON

 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/
PRODUCT: Medgel Suspension
(Sucralfate) Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 4 of 5
21.06.2016 21-06-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: MG Batch Size: 1200 ltrs. Shelf Life: 03 years

1.080kg Sodium Benzoate Time OFF

1.200kg Sodium citrate

1.200kg sodium saccharine Solution Clarity

Mix thoroughly until clear the solution

Then add into step#1

Note:Mix in separate bucket

4 Add directly Time ON

__________kg sucralfate into step#1 and

mix continuously and
Time OFF
Add0.480Lts.
Anise Flavor and mix for 30 minutes
Leave for overnight if necessary

STEP PARAMETER PERFORMED

OPERATION VERIFIED BY DATE
NO. CHECKED BY
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/
PRODUCT: Medgel Suspension
(Sucralfate) Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 5 of 5
21.06.2016 21-06-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: MG Batch Size: 1200 ltrs. Shelf Life: 03 years

5 Next day make up the volume and mix for

30 minutes and inform QAI for sampling. Time ON

Time OFF

PRODUCTION REMARKS:
____________________________________________________________________________________________

DOCUMENT VERIFICATION:

Verified By:________________________________ Authenticated By:----------------------------------

( InchargeSection ) (Prod.manager)

SUBMISSION OF BMO:

Submit Batch Manufacturing Order to Q.A Department for collection of sample and Analysis.

BMO SUBMITTED BY:_______________________ Date :_________________

BMO RECEIVED BY: ________________________ Date :_________________

QUALITY ASSURANCE REMARKS:

________________________________________________________________________