BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /307
PRODUCT: Kufrid Syrup
(Aminophyllin, Diphenhydramine and Supercedes date:
SOP No.:
Ammonium Chlorid)
ISSUE DATE: To REVISED ON: Revision No: Page No: 1 of 7
14.04.2016 14-04-2021
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: KF Batch Size: 1200lts. Shelf Life: 02 Years

MANUFACTURING FORMULA
Overage
S. No Ingredients Std. Qty Factor Included Addn Act. Qty Unit Q.C. No Issued By Verified By

1 *Aminophylin B.P 8.060 05% Kg.

2 *Diphenhydramine HCl B.P 2.020 05% Kg.
3 *Ammonium Chloride B.P 7.600 05% Kg
4 *Menthol B.P 0.235 Kg.
5 Ethanol (Alcohol) 30.00 Lt.
6 Sorbitol 70% 48.00 Kg
7 Glycerine 60.00 Kg.
8 Citric acid (Monohydrate) 2.400 Kg.
9 Sodium Citrate 0.410 Kg.
10 Sugar (Local) 250.0 Kg.
11 Caramel Colour 1.800 Kg.
12 Methylparaben 1.200 Kg.
13 Propylparaben 0.450 Kg.
14 Sodium Saccharin 0.240 Kg.
15 Neotame 0.0288 kg
16 Raspberry Flavour W/S 0.300 Lt.
17 Vanilla flavour W/S 0.300 Lt.
18 D.I Water qS to make 1200 Lt.
* Quantity of Active Ingredient to be adjusted on the basis of
its Factor
Raised By Verified By Received By
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /307
PRODUCT: Kufrid Syrup
(Aminophyllin, Diphenhydramine and Supercedes date:
SOP No.:
Ammonium Chlorid)
ISSUE DATE: To REVISED ON: Revision No: Page No: 2 of 7
14.04.2016 14-04-2021
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: KF Batch Size: 1200lts. Shelf Life: 02 Years

Section incharge QC Manager RMS

CLEANING RECORD

NAME OF EQUIPMENT

EQUIPMENT NUMBER

PRODUCT LAST
MANUFACTURED

BATCH NO.

CLEANED BY

DATE

__________ ___________
Section incharge: Verified by QAI
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /307
PRODUCT: Kufrid Syrup
(Aminophyllin, Diphenhydramine and Supercedes date:
SOP No.:
Ammonium Chlorid)
ISSUE DATE: To REVISED ON: Revision No: Page No: 3 of 7
14.04.2016 14-04-2021
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: KF Batch Size: 1200lts. Shelf Life: 02 Years

MANUFACTURING INSTRUCTIONS
PRECAUTIONS:

1. PROCESS WORKER 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 PERFORME VERIFIED

OPERATION DATE
NO. CHECKED D BY BY
1. Base Preparation Tank No
Take
250 Lt. D.I. water in SS tank.
Heat up to 75ºC to 80 ºC. Temperature

Add 1.200 Kg Methylparaben and0.450 Kg Time ON

Propylparaben,250.0 Kg Sugar and
0.0288kg Neotame

Mix till dissolved. Time OFF

Note: Temperature should not exceed Temperature

above 80ºC.

Cool the syrup 45ºC to 50ºC.

 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /307
PRODUCT: Kufrid Syrup
(Aminophyllin, Diphenhydramine and Supercedes date:
SOP No.:
Ammonium Chlorid)
ISSUE DATE: To REVISED ON: Revision No: Page No: 4 of 7
14.04.2016 14-04-2021
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: KF Batch Size: 1200lts. Shelf Life: 02 Years

2. Transfer the syrup base to batch

manufacturing tank through Nylon/Teflon
cloth

STEP PARAMETER PERFORME VERIFIED

NO. OPERATION DATE
CHECKED D BY BY
3. Dissolve in
Clarity of Solution:
200 Lt. D.I water

_____________ Kg Ammonium chloride

B.P
Temperature
0.240 Kg Sodium Saccharin
0.410 Kg Sodium Citrate
2.400 Kg Citric acid
Time ON
60.00 Kg Glycerin

Mix for 10 minutes.

Time OFF
If required heat it to 50ºC.

Add to step # 2

4. Dissolve in 20.0 Lt D.I water

Time ON
_____________ Kg Aminophyline B.P Add
to step #3, Mix for 10 minutes.
Time OFF
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /307
PRODUCT: Kufrid Syrup
(Aminophyllin, Diphenhydramine and Supercedes date:
SOP No.:
Ammonium Chlorid)
ISSUE DATE: To REVISED ON: Revision No: Page No: 5 of 7
14.04.2016 14-04-2021
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: KF Batch Size: 1200lts. Shelf Life: 02 Years

5. Dissolve in 10.0 Lt. D.I water

____________ Kg. Diphenhydramine HCl Time ON
B.P
Mix for 5 minutes.
Add to step # 4 Time OFF

STEP PARAMETER PERFORME VERIFIED

NO. OPERATION DATE
CHECKED D BY BY
6. Dissolve in 30.0 Lt Alcohol (Ethanol)
__________ Kg Menthol B.P Time ON

1.800 Kg Caramel Colour Time OFF

Mix for 5 minutes then

Time ON
Add to step # 5

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

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /307
PRODUCT: Kufrid Syrup
(Aminophyllin, Diphenhydramine and Supercedes date:
SOP No.:
Ammonium Chlorid)
ISSUE DATE: To REVISED ON: Revision No: Page No: 6 of 7
14.04.2016 14-04-2021
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: KF Batch Size: 1200lts. Shelf Life: 02 Years

7. Add to step # 6
48.00 Kg Sorbitol 70% Time ON
0.300 Lt Raspberry flavour
0.300 Lt Vanilla flavour
Time OFF
Mix for 5 minutes

Filter the batch through filter assembly in

Batch Storage Tank. Make up the volume Time ON
1200 Lt

Time OFF
Mix for 10 minutes
 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /307
PRODUCT: Kufrid Syrup
(Aminophyllin, Diphenhydramine and Supercedes date:
SOP No.:
Ammonium Chlorid)
ISSUE DATE: To REVISED ON: Revision No: Page No: 7 of 7
14.04.2016 14-04-2021
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: KF Batch Size: 1200lts. Shelf Life: 02 Years

PRODUCTION REMARKS:
_______________________________________________________________________________________________
_______________________________________________________________________________________________

DOCUMENT VERIFICATION:

Verified By: _________________________ Authenticated _________________________

(Section Incharge) (Manager Production)

SUBMISSION OF BMO:

Submit Batch Manufacturing Order to Quality Assurance department for collection of sample and analysis.

BMO SUBMITTED BY: _______________________ Date: _________________________

BMO RECEIVED BY: ________________________ Date: _________________________

QUALITY ASSURANCE REMARKS:

_______________________________________________________________________________________________
_______________________________________________________________________________________________