BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /3/011
PRODUCT: Mediplex-L Syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: 1 Page No: 1 of 7
18.04.2016 18-04-2021
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: MP Shelf Life: 2 years Batch Size: 1200Lts.

Manufacturing Formula

S.No Ingredients Std. Qty % Purity Addnl Act. Qty Unit Q.C.No Issued By Verified By
0.300
1 Thiamine HCl (B1) Kg
0.300
2 Riboflavin(B2) Kg

3 Pyridoxine HCl (B6) 0.200 Kg

4 Nicotinamide (B3) 2.300 Kg
5 L –Lysine Mono HCl 4.000 Kg
6 Sugar (Local) 240.00 Kg
7 Liquid Glucose 300.00 Kg
8 Sorbitol (70% Solution) 30.00 kg
9 Methyl Paraben 2.160 Kg
10 Propyl Paraben 0.240 Kg
11 Sodium benzoate 1.200 Kg
12 Citric Acid(Mono Hydrate) 2.160 Kg
13 Flavour Orange 1.080 Lts
14 CMC –7HOF 2.350 Kg
15 Sodium Saccharin 0.480 Kg
16 Neotame 0.0075 kg
17 D.I Water q.s 1200.00 Lts

Raised By Verified 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 / BMO /3/011
PRODUCT: Mediplex-L Syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: 1 Page No: 2 of 7
18.04.2016 18-04-2021
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: MP Shelf Life: 2 years Batch Size: 1200Lts.

CLEANING RECORD

NAME OF EQUIPMENT

EQUIPMENT NUMBER

PRODUCT LAST
MANUFACTURED

BATCH NO

CLEANED BY

DATE

VERIFIED BY

DATE

Production Officer:____________ QA Inspecter:_____________

Date: ____/____/___Time:________ Date: ____/____/___Time:________

 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /3/011
PRODUCT: Mediplex-L Syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: 1 Page No: 3 of 7
18.04.2016 18-04-2021
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: MP Shelf Life: 2 years Batch Size: 1200Lts.

MANUFACTURING INSTRUCTIONS
PRECAUTIONS:

1. PROCESS WORKER MUST WEAR FACEMASK AND GLOVE.

2. ALL EQUIPMENT MUST BE CLEANED AND PROPERLY LABELED.
3. PROTECT THE PRODUCT FROM UNNECESSARY EXPOSURE TO LIGHT.
PROCEDURES.

STEP OPERATION PARAMETER PERFORM CHECKED

NO. CHECKED ED BY BY DATE

1 Take Tank No
170 liters D.I. water in Main S.S tank.
Heat up to 75ºC to 80ºC.
Temperature
Add Into It

240.0 kg Sugar(Local)

2.160 Kg Methyl paraben Time On:

0.240 Kg Propyl paraben

0.0075kg Neotame
Time Off:
Mix For 10 Minutes

Note: Temperature should not exceed above 80ºC.

Cool the syrup to 40ºC-80ºC

 BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /3/011
PRODUCT: Mediplex-L Syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: 1 Page No: 4 of 7
18.04.2016 18-04-2021
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: MP Shelf Life: 2 years Batch Size: 1200Lts.

STEP OPERATION PARAMETER PERFORM CHECKED

NO. CHECKED ED BY BY DATE

2 Transfer the syrup base to suitable batch

Volume:
manufacturing tank through Nylon cloth.

Mix for 30 minutes Time ON:

Time OFF:

3 Add To step 2
Time on
300.00Kg Liduid glucose

30.00 Kg Sorbitol(70% Solution) Time off

Mix For 30 Minutes.

STEP OPERATION PARAMETER PERFORM CHECKED

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

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /3/011
PRODUCT: Mediplex-L Syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: 1 Page No: 5 of 7
18.04.2016 18-04-2021
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: MP Shelf Life: 2 years Batch Size: 1200Lts.

4 Volume
Dissolve in 5.000 Lts D.I. Water
Time on
1.200 Kg Sodium Benzoate
0.480 Kg Sodium Saccharin Time off
Mix for 5 minutes
And add to step # 3

Take 50.00 Lts D.I. Water in bucket

Add on by one
5 ___________ Kg Thiamine HCl Time on
___________ Kg Pyridoxine HCl
___________ Kg Nicotinamide Time off
___________Kg L-Lysine HCL

Mix for 10 minutes and add to step # 04

STEP OPERATION PARAMETER PERFORM CHECKED

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

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /3/011
PRODUCT: Mediplex-L Syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: 1 Page No: 6 of 7
18.04.2016 18-04-2021
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: MP Shelf Life: 2 years Batch Size: 1200Lts.

6.
Take 150.000 Lts D.I. Water in S.S Container: Volume
and add into it

__________ Kg Riboflavin
Time on
2.160 Kg Citric acid

Mix for 10 minutes

Check the solution clarity Time off

And add to step # 05
Solution Clarity

7. Take 50.000 Lts. D.I. Water in separate bucket and

soak into it.
Volume
2.350 Kg CMC 7HOF

Mix for 10 minutes

Time on
Leave for overnight and

Add to step # 02
Time off

STEP OPERATION PARAMETER PERFORM CHECKED

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

Department: Production Section: liquid

ISO No. PRD-LIQ / BMO /3/011
PRODUCT: Mediplex-L Syrup
Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: 1 Page No: 7 of 7
18.04.2016 18-04-2021
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: MP Shelf Life: 2 years Batch Size: 1200Lts.

8. Finally add Volume

1.080 Lts. Flavor Orange

Filter the batch through filter assembly to Time on

Storage tank. Make up the volume up to

1200 Lts Time off

Mix for 5 minutes

Production Remarks:
_______________________________________________________________________________________________
______________________________________________________________________________________________

DOCUMENT VERIFICATION:

Verified By: _________________________ Authenticated By: ____________________

SUBMISSION OF BMO:

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

BATCH HISTORY SUBMITTED BY:_______________________ Date :_________________

BATCH HISTORY RECEIVED BY: ________________________ Date: _________________

Quality Assurance Remarks:

_______________________________________________________________________________________________
_______________________________________________________________________________________________