MFR OF MULTIVITAMIN SYRUP

PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

1. Master Copy: Manager Quality Assurance
2. Copy No. 1: Production Pharmacist
3. Copy No. 2: Manager Quality Control
4. Copy No. 3: Liquid Section

 MANUFACTURING SPECIFICATION:

1. Average fill of each Bottle is 225 ml.
2. Volume variation limit allowed in each filled Bottle is 225 ml to 226 ml.
3. Make up the final volume of the syrup accurately.
4. Filter the completely charged batch using Filter Press L-21 by operating it as per its SOP.
5. Transfer the syrup from charging tank L-10 to storage tank L-14 after complete charging of batch.
6. Mix the batch, Fill the bottles and also perform the primary packing of bottles at temperature not more than 25⁰ C and Relative Humidity not more than 40.

Yield:

• Theoretical Yield is 13333 Bottles.
• Expected Practical Yield is 13333 + 2% Bottles.

Packing Details:

1. Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP.
2. Transfer the Syrup from storage tank to Digipack Bottle Filling and Sealing Machine for filling and sealing of the bottles as per its SOP.
3. Fill 225 ml syrup in amber glass brute bottle and use 25 mm PP Cap to seal the bottle mouth.
4. Inspect the each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.
5. Label every inspected bottle by using the Automatic Bottle Labelling Machine .
6. Pack each filled and sealed bottle in unit carton individually.
7. Pack 30 unit cartons in specified corrugated box to give a pack size of 30 x 225 ml.
8. Seal each corrugated box with adhesive tape and label it properly by affixing the specified label. 

MANUFACTURING PROCESS:

1. I) Preparation of Sugar Syrup:

1. Take Purified water 600 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank .
2. Run the steam into the jacket so as to heat the water.
3. Add 1800 kgs of sugar into the tank and start stirring by operating the tank .
4. Heat continuously till the sugar dissolves completely to give uniform Sugar Syrup.
5. Transfer the prepared Sugar Syrup to Sugar Syrup Storage Tank through transfer pump.
6. Transfer the 300 kgs Liquid Glucose to the Sugar Syrup Storage Tank and stir it vigoursly for half an hour to dissolve it  in the Sugar Syrup completely.
7. Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank through transfer pump.
8. II) Addition of Ingredients into the Charging Tank L-10 while stirring continuously:
9. Dissolve 3.0 kgs of Methyl Paraben Sodium, 0.750 kgs of Propyl Paraben Sodium in 20  Ltrs of  Purified water and add to the bulk batch.
10. Dissolve 15.0 kgs of Sodium Benzoate in 60 Ltrs of  Purified water and add to the bulk batch.
11. Dissolve 2.4 kgs of Citric Acid in 10  Ltrs of  Purified water and add to the bulk batch.
12. Dissolve 3.75 kgs of Vitamin B1 HCl in 20 Ltrs of Purified water and add to the bulk batch.
13. Dissolve 2.551 kgs of Vitamin B2 Phosphate in 60 Ltrs of DM water and add to the bulk batch.
14. Dissolve 1.200 kgs of Vitamin B6 HCl in 10 Ltrs of Purified water and add to the bulk batch.
15. 650 kgs of D – Panthenol in 10 Ltrs of Purified water and add to the bulk batch.
16. Dissolve 16.5 kgs of Niacinamide in 50 Ltrs of Purified water and add to the bulk batch.
17. Dissolve 3.0 gms of Vitamin B12 in 6 Ltrs of Purified water and add to the bulk batch.
18. Dissolve 3.0 gms of Carmoisine colour in the 5 Ltrs of hot water and add to the bulk batch.
19. Add 1.5 Ltrs of Lemon Flavour, 1.5 Ltrs of Orange Flavour ,1.5 Ltrs of Pineapple Flavour ,1.5 Ltrs of Raspberry Flavour to the bulk batch.
20. Add 60 x 450 ml of the Spirit Chloroform to the bulk batch.
21. Make up the volume with DM water and mix until homogeneous.
22. Check the pH of Solution to be in between 4.0 – 4.5.
23. Filter the batch through Filter Press by operating it as per its SOP and transfer it to the Storage Tank.
24. Send the sample to Quality Control Department for bulk testing.

IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
2. All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
4. Final volume should be made as per Standard Operating Procedure using correct dipstick in the Manufacturing Chemist.
5. pH of the bulk should be checked and it should be with in specified limits.
6. Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
7. Intermittently filled volume should be checked at 30 minutes interval by the Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.
8. The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

      Limit for Volume Variation  :  Volume claimed on the label + 2ml

9. Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.
10. Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.
11. The labels and cartons should be checked thoroughly for proper batch coding.
12. Intimation should be sent to Quality Control Department for finished product sampling and testing.
13. After the completion of labelling and packaging, the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.
14. It will be ensure that filling or packaging equipment has been properly cleaned.
15. Filling or packaging of next product should not commence until the ‘Line Clearance’ has been given by the IPQA.

MFR OF GATIFLOXACIN 400MG TABLET