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:
- Master Copy: Manager Quality Assurance
- Copy No. 1: Production Pharmacist
- Copy No. 2: Manager Quality Control
- Copy No. 3: Liquid Section
|PRODUCT NAME:||VITCON SYRUP||BATCH SIZE:||3000 LTRS.|
|DOSAGE FORM:||LIQUID DEPARTMENT||UNIT SIZE:||225 ml|
|EXPIRY DATE:||AFTER 18 MONTHS FROM THE DATE OF MANUFACTURING||PACK SIZE:||30 x 225|
|Each 5 ml contains:|
|Vitamin B1||IP||5 mg|
|Vitamin B12||IP||2.5 mcg|
|Vitamin B2-5 Phosphate Sodium eq. to Vitamin B2||IP||2.5 mg|
|Vitamin B6||IP||1.5 mg|
|Vitamin B12||IP||2.5 mcg|
|EQUIPMENTS TO BE USED:|
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING|
AS PER SOP NO.
AS PER SOP NO.
|1||Sugar Syrup Manufacturing Tank|
|2||Sugar Storage Tank|
|3||Charging Tank – V – 3500 Ltrs.|
|5||Storage Tank – III – 3500 Ltrs|
|6||Linear Bottle Washing Machine|
|7||Digipack Bottle Filling and Sealing Machine|
|8||Automatic Bottle Labelling Machine|
|1.||CARMOSINE COLOUR||F.G||3.000||3.000 GMS|
|2.||CITRIC ACID||I.P.||2.400||2.400 KGS|
|3.||D – PANTHENOL||I.P.||1.500||10.00||1.650 KGS|
|4.||LEMON FLAVOUR||F.G.||1.500||1.500 LTRS.|
|5||LIQUID GLUCOSE||I.P.||300.00||300.000 KGS|
|6||METHYL PARABEN SODIUM||I.P.||3.000||3.000 KGS|
|8||ORANGE FLAVOUR||I.P.||1.500||1.500 LTRS|
|9.||PROPY PARABEN SODIUM||I.P.||0.750||0.750 KGS|
|10.||PINEAPPLE FLAVOUR||F.G.||1.500||1.500 LTRS|
|11.||RASPBERRY FLAVOUR||F.G||1.500||1.500 LTRS.|
|12.||SODIUM BENZOATE||I.P.||15.000||15.000 KGS|
|13.||SPIRIT CHLOROFORM||I.P.||12.000||12.00 KGS|
|15.||VITAMIN B1 HCL||I.P.||3.000||25.00||3.750 KGS|
|16.||VITAMIN B2 – 5 PHOSPHATE||I.P.||2.085||22.34||2.551 KGS|
|17.||VITAMIN – B6 HCL||I.P.||0.900||33.33||1.200 KGS|
|18.||VITAMIN – B12||I.P.||1.500||100.00||3.000 GMS|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR |
|TOTAL QUANTITY USED|
|1.||200/ 225 ML AMBER ROUND BRUT BOTTLES||13333.333||13333.333 NOS|
|2.||ADHESIVE TAPE ROLL BROWN||6.000||6.000 NOS|
|4.||UNIT CARTON||13333.333||13333.333 NOS|
|5||GUM ACCACIA||1.000||1.000 KGS|
|6||CORRUGATED BOXES I||444.444||444.444 NOS|
|PILFER PROOFS CAPS 25 MM||13333.333||13333.333 NOS|
- Average fill of each Bottle is 225 ml.
- Volume variation limit allowed in each filled Bottle is 225 ml to 226 ml.
- Make up the final volume of the syrup accurately.
- Filter the completely charged batch using Filter Press L-21 by operating it as per its SOP.
- Transfer the syrup from charging tank L-10 to storage tank L-14 after complete charging of batch.
- 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.
- Theoretical Yield is 13333 Bottles.
- Expected Practical Yield is 13333 + 2% Bottles.
- Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP.
- Transfer the Syrup from storage tank to Digipack Bottle Filling and Sealing Machine for filling and sealing of the bottles as per its SOP.
- Fill 225 ml syrup in amber glass brute bottle and use 25 mm PP Cap to seal the bottle mouth.
- Inspect the each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.
- Label every inspected bottle by using the Automatic Bottle Labelling Machine .
- Pack each filled and sealed bottle in unit carton individually.
- Pack 30 unit cartons in specified corrugated box to give a pack size of 30 x 225 ml.
- Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
- I) Preparation of Sugar Syrup:
- Take Purified water 600 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank .
- Run the steam into the jacket so as to heat the water.
- Add 1800 kgs of sugar into the tank and start stirring by operating the tank .
- Heat continuously till the sugar dissolves completely to give uniform Sugar Syrup.
- Transfer the prepared Sugar Syrup to Sugar Syrup Storage Tank through transfer pump.
- 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.
- Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank through transfer pump.
- II) Addition of Ingredients into the Charging Tank L-10 while stirring continuously:
- 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.
- Dissolve 15.0 kgs of Sodium Benzoate in 60 Ltrs of Purified water and add to the bulk batch.
- Dissolve 2.4 kgs of Citric Acid in 10 Ltrs of Purified water and add to the bulk batch.
- Dissolve 3.75 kgs of Vitamin B1 HCl in 20 Ltrs of Purified water and add to the bulk batch.
- Dissolve 2.551 kgs of Vitamin B2 Phosphate in 60 Ltrs of DM water and add to the bulk batch.
- Dissolve 1.200 kgs of Vitamin B6 HCl in 10 Ltrs of Purified water and add to the bulk batch.
- 650 kgs of D – Panthenol in 10 Ltrs of Purified water and add to the bulk batch.
- Dissolve 16.5 kgs of Niacinamide in 50 Ltrs of Purified water and add to the bulk batch.
- Dissolve 3.0 gms of Vitamin B12 in 6 Ltrs of Purified water and add to the bulk batch.
- Dissolve 3.0 gms of Carmoisine colour in the 5 Ltrs of hot water and add to the bulk batch.
- 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.
- Add 60 x 450 ml of the Spirit Chloroform to the bulk batch.
- Make up the volume with DM water and mix until homogeneous.
- Check the pH of Solution to be in between 4.0 – 4.5.
- Filter the batch through Filter Press by operating it as per its SOP and transfer it to the Storage Tank.
- Send the sample to Quality Control Department for bulk testing.
The following in-process controls should be maintained during the processing:
- Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
- 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.
- Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
- Final volume should be made as per Standard Operating Procedure using correct dipstick in the Manufacturing Chemist.
- pH of the bulk should be checked and it should be with in specified limits.
- Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
- 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.
- 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
- 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.
- Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.
- The labels and cartons should be checked thoroughly for proper batch coding.
- Intimation should be sent to Quality Control Department for finished product sampling and testing.
- 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.
- It will be ensure that filling or packaging equipment has been properly cleaned.
- Filling or packaging of next product should not commence until the ‘Line Clearance’ has been given by the IPQA.