BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
Department: Production Section: Liquid
ISO No. PRD-LIQ/3/
PRODUCT: Neuropal Suspension
(Pyritinol dihydrochloride=100mg) Supercedes date:
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 1 of 5
28.06.2016 28-06-2021
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: NC Shelf Life: 02 year Batch Size:
DATE BATCH STARTED : DATE BATCH COMPLETED:
MANUFACTURING FORMULA
Std. Issued Verified
S.No Ingredients Factor Addnl Act. Qty Unit QC# By By
Qty/5ml
*Pyritinol dihydochloride 100mg Kg.
1. (Factor=1.242)
2. Sugar 1500mg Kg.
3. Liquid glucose 4000mg Kg
4. Methyl paraben Sodium 3.7mg Kg.
5. Propyl paraben sodium 1.125mg Kg.
6. Orange flavor 5.0µl Lts.
7. Polysacrolose 60mg Kg.
8. Aspartame 30mg kg
9. Titanium dioxide 8.0mg kg
10. 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: Neuropal Suspension
(Pyritinol dihydrochloride=100mg) Supercedes date:
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 2 of 5
28.06.2016 28-06-2021
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: NC Shelf Life: 02 year Batch Size:
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: Neuropal Suspension
(Pyritinol dihydrochloride=100mg) Supercedes date:
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 3 of 5
28.06.2016 28-06-2021
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: NC Shelf Life: 02 year Batch Size:
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 300 Lt. D.I. water in SS tank Tank No
Heat up to 60º C.
Add into it Temperature
________kg sugar Time ON
________kg Methyl paraben sodium
________kg Propyl paraben sodium Time OFF
Thoroughly mix for at least 15 minutes
BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
Department: Production Section: Liquid
ISO No. PRD-LIQ/3/
PRODUCT: Neuropal Suspension
(Pyritinol dihydrochloride=100mg) Supercedes date:
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 4 of 5
28.06.2016 28-06-2021
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: NC Shelf Life: 02 year Batch Size:
2 Take ________kg liquid glucose and mix for Time ON
30 minutes
Time OFF
3 Take ________ liters DI water add into it: Time ON
________Kg Tio2
Time OFF
Mix thoroughly for 10 minutes
4 Take________ liters DI water add into it: Time ON
____________kg Aspartame
Time OFF
Mix thoroughly for 10 minutes
BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
Department: Production Section: Liquid
ISO No. PRD-LIQ/3/
PRODUCT: Neuropal Suspension
(Pyritinol dihydrochloride=100mg) Supercedes date:
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 5 of 5
28.06.2016 28-06-2021
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: NC Shelf Life: 02 year Batch Size:
5 Take________liters DI water add into it: Time ON
___________kg Polyscrolose
Time OFF
Mix thoroughly for 10 minutes
6 Take________ liters DI water add into it: Time ON
____________kg Pyritinol dihydrochloride
Mix thoroughly for 10 minutes
Time OFF
7 Finally add ___________________ltrs flavor
orange,mix it for 10 minutes and make up
the volume________liters
BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
Department: Production Section: Liquid
ISO No. PRD-LIQ/3/
PRODUCT: Neuropal Suspension
(Pyritinol dihydrochloride=100mg) Supercedes date:
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 6 of 5
28.06.2016 28-06-2021
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: NC Shelf Life: 02 year Batch Size:
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:
_______________________________________________________________________________________________
_______________________________________________________________________________________________
