BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/312
PRODUCT: CTZINE SYRUP
Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 1 of 6
01.04.2016 01-04-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: CT Batch Size: Shelf Life: 03 years

MANUFACTURING FORMULA
Act. Issued Verified
S.No Ingredients Std. Qty Factor Addnl Unit Q.C.No By By
Qty
1. *Cetirizine 1.224 Kg.
Hydrochloride
2. Citric acid 1.200 Kg.
3. Sodium citrate 0.840 Kg
4. Sugar 360.0 Kg.
5. Sorbitol (70 % solution) 120.0 Kg.
6. Methylparaben Sodium 2.160 Kg
7. Propylparaben Sodium 0.240 Kg.
8. Orange flavour 0.072 Lt.
9. Neotame 0.0228 kg
10. D.I.Water q.s to make 1200 Lt.
*Quantity of Active ingredients to be adjusted on the basis of factor.

Raised By Verified By: Received By: Required Date/Time

Section Incharge QC Manager RMS

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

MATERIAL RETURN TO RMS:

S. No Material Quantity QC No. Returned By Received By Remarks

 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/312
PRODUCT: CTZINE SYRUP
Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 2 of 6
01.04.2016 01-04-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: CT Batch Size: 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/3/312
PRODUCT: CTZINE SYRUP
Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 3 of 6
01.04.2016 01-04-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: CT Batch Size: 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
300.00 Lt. D.I. water in SS tank.
Heat up to 75º C to 80º C.
Temperature
Add
Time ON
360.0 Kg Sugar (local)

Stir until Dissolve,and add 0.0228kg

Neotame Time OFF

Note: Temperature should not exceed Temperature

above 80ºC.

Cool the syrup base 45 to 50ºC.

2 Take 150.00 Lt D.I. water in SS tank . Time ON

2.160 Kg Methylparaben Sodium

0.240 Kg Propylparaben Sodium

Time OFF
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/312
PRODUCT: CTZINE SYRUP
Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 4 of 6
01.04.2016 01-04-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: CT Batch Size: Shelf Life: 03 years

0.840 Kg Sodium citrate

Mix for 10 minutes

3 Add to step# 2 Time ON

120.0 Kg Sorbitol Solution

Time OFF
Mix for 15 minutes.

4 Dissolve in 10.0 Lt. D.I. water Time ON

1.20 Kg Citric acid
Add to step # 3.
Time OFF
Mix for 5 minutes.
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/312
PRODUCT: CTZINE SYRUP
Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 5 of 6
01.04.2016 01-04-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: CT Batch Size: Shelf Life: 03 years

STEP PARAMETER PERFORMED

OPERATION VERIFIED BY DATE
NO. CHECKED BY

5 Dissolve in 10.0 Lt. D.I water Solution Clarity

_____ Kg Cetirizine HCl

Time ON
Check the clarity of solution

Add to step #4

Mix for 15 minutes. Time OFF

6 Add to step # 5 Volume

0.072 Lt Flavour orange
Make up the volume to 1200 Lt. with D.I
water and filter through filter assembly. Time ON
Mix for 15 minutes.
Time OFF

PRODUCTION REMARKS:
_______________________________________________________________________________________________
_______________________________________________________________________________________________

DOCUMENT VERIFICATION:

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

( InchargeSection ) (Prod.manager)

Date:_____________________
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: Liquid

ISO No. PRD-LIQ/3/312
PRODUCT: CTZINE SYRUP
Supercedes date: Prd-LIQ/3/003
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 6 of 6
01.04.2016 01-04-2021
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. I/C Section Desig. Prod. Manager_ Desig. Sr.Q.A.I___________ Desig. QC Manager_ Desig. Prod.director___

Batch No: Product Code: CT Batch Size: Shelf Life: 03 years

SUBMISSION OF BMO:

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

BMO SUBMITTED BY:_______________________ Date :_________________

BMO RECEIVED BY: ________________________ Date :_________________

QUALITY ASSURANCE REMARKS:

________________________________________________________________________