Manufacturing Formula: PRODUCT: Enzovit Syrup

BATCH MANUFACTURING ORDER
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

ISO No. PRD-ANT / BMO /3/313
PRODUCT: Enzovit Syrup Supercedes date: NEW
SOP No.: NEW
ISSUE DATE: To REVISED ON: Revision No: New Page No: 1 of 6
25.04.2016 25-04-2021
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: EZ Shelf Life:18 months Batch Size: 2400Lts.
MANUFACTURING FORMULA
Issued
Act. Verified By
S. No Ingredients Std. Qty Factor Addn Q.C. No By
Qty(KG)
1. *30.00
*Pepsin
*30.00
2. *Papain
*2.880
3. *Thiamine HCl
4. *Riboflavin *1.152
5. *Pyridoxine HCl *1.152
6. *Cyanocobalamine *0.003120
7. *Nicotinamide *11.520
8. *Calcium-D-Pentothenate *0.576
9. Sugar (local) 360.00
10. Liquid Glucose 360.00
11. Sorbitol 70% 60.00
12. Methylparaben 1.920
13. Propylparaben 0.600
14. Sodium Benzoate 3.600
15. CMC 7 HOF 4.200
16. Citric Acid (Monohydrate) 4.500
17. Acidacid(Monohydrate)
Colour Apple Green 0.900
18. Flavour Pineapple 2.016
19. Sodium Hydroxide (Pellets) 0.168
20. Neotame 0.015

21. Sodium Saccharine 0.960
22. D.I. Water q.s to 2400
Note:Quantity of active ingredients to be adjusted on basis of its factor.
Raised By(I/c Liquid) Verified By(Q.C.M) Received By(R.M.S) Required Date/Time
SOP No.: NEW
25.04.2016 25-04-2021
CLEANING RECORD
NAME OF EQUIPMENT
EQUIPMENT NUMBER
PRODUCT LAST
MANUFACTURED
BATCH NO.
CLEANED BY
DATE
VERIFIED BY
DATE
Checked By(section incharge): __________________ Verified By(QAI):_______________

SOP No.: NEW
25.04.2016 25-04-2021
MANUFACTURING INSTRUCTIONS
PRECAUTIONS:
1. PROCESS WORKER MUST WEAR FACE MASK, 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
OPERATION PERFORMED BY VERIFIED BY
NO. CHECKED DATE
1 Take Temperature
500.0 Lt. D.I. water in SS tank.
Heat up to 75ºC to 80 ºC.
Add in to it, Solution clarity
1.920 Kg Methylparaben
0.600 Kg Propylparaben
3.600 Kg Sodium benzoate
4.500 Kg Citric Acid (Monohydrate).
360.000 kg sugar and 0.015kg Neotame Temperature
Stir till dissolved. .
Check the clarity of Solution.
Cool to 40 to 45oC.
2 Add to step # 1
60.000 Kg Sorbitol 70% Time ON:
360.000 Kg Liquid Glucose
0.960kg sodium saccharine
Mix for 30 minutes.
Time OFF:
SOP No.: NEW
25.04.2016 25-04-2021
3 Dissolve in 20.000 Lt D.I. water

Time ON:
_______ Kg Thiamine HCl
_______ Kg Pyridoxine HCl
Mix for 10 minutes
Add to step # 2 Time OFF:
4 Dissolve in 20.00 Lt. D.I. water

______ Kg Nicotinamide Time ON:
______ Kg Calcium-D-Pentothenate
______ Kg Cyanocobalamine
Time OFF:
Mix for 15 minutes.
Add to step # 3.
5 Dissolve in 30.0 Lt D.I Water

Time ON:
0.168 Kg Sodium Hydroxide(pellets)
_____ Kg Riboflavin
Stir till dissolve Time OFF:

Mix for 5 minutes.
Add to step # 4
6 Dissolve separately in 50.000 Lt.
D.I Water Time ON:
_____ Kg Pepsin
_____ Kg Papain
Stir till dissolve
Add to step # 5
Mix for 5 minutes. Time OFF:
SOP No.: NEW
25.04.2016 25-04-2021
7 Disperse separately in 70.00 Lt. D.I. water
4.20 Kg CMC 7 HOF Time ON:
Stir well.
Mix for 30 minutes
Add this to step # 6
Time OFF:
8 Dissolve in 10.0 Lts of D.I Water

0.900 Kg Colour Apple green Time ON:
2.0160 Lt Flavour Pine apple
Mix for 5 minutes
Add into step # 7 Time OFF:
Filter the batch through filter assembly to
storage tank. Make the volume to 2400 Lits.
Mix for 15 minutes.
Volume
Time ON:
Time OFF:
PRODUCTION REMARKS:
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
SOP No.: NEW
25.04.2016 25-04-2021
DOCUMENT VERIFICATION:
Verified By(section incharge): ________________ Authenticated By(Prod.manager): __________________
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:___________________________________________________________________
________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
______________________________________________________________________________________________________

Manufacturing Formula: PRODUCT: Enzovit Syrup

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Manufacturing Formula: PRODUCT: Enzovit Syrup

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BATCH MANUFACTURING ORDER

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

20. Neotame 0.015

Checked By(section incharge): ____ Verified By(QAI):_

3 Dissolve in 20.000 Lt D.I. water

4 Dissolve in 20.00 Lt. D.I. water

5 Dissolve in 30.0 Lt D.I Water

Stir till dissolve Time OFF:

8 Dissolve in 10.0 Lts of D.I Water

Verified By(section incharge): Authenticated By(Prod.manager): __

BMO. SUBMITTED BY: _ Date: ___

BMO. RECEIVED BY: Date: _

QUALITY ASSURANCE REMARKS:___________________________________________________________________

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