MASTER FORMULA OF MULTI VITAMIN – 100 ML
PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE: This MFR 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 and cGMP Administrator are accountable for the strict adherence to the master.
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 : cGMP Administrator
5. Copy No. 4 : Liquid Section
|PRODUCT NAME: MULTI VITAMIN SYRUP||BATCH SIZE: 2000 LTRS.|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 100 ml|
|GENERIC NAME: N.A.||PACK SIZE: 42 x 100 ML|
|DOSAGE FORM: SYRUP||STRENGTH: N.A.|
|DEPARTMENT: LIQUID DEPARTMENT||EXPIRY DATE: AFTER 18 MONTHS FROM THE DATE OF MANUFACTURING|
Each 5 ml contains:
Vitamin A (as Palmitate) I.P. 1600 I.U. Nicotinamide I.P. 10 mg
Vitamin D3 I.P. 200 I.U. D-Panthenol I.P. 2.5 mg
Thiamine Hydrochloride I.P. 1.5 mg Ferrous Gluconate I.P. 26 mg
Riboflavine I.P. 1.5 mg (equ. To Elemental Iron 3 mg)
Pyridoxine Hydrochloride I.P. 1 mg Zinc Sulphate I.P. 44 mg
Cynocobalamin I.P. 1 mcg (equ. To elemental Zinc 10 mg)
SPECIMEN OF LABEL :
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 – 3500 Ltrs.|
|5||Storage Tank – 3500 Ltrs|
|6||Linear Bottle Washing Machine|
|7||Digipack Bottle Filling and Sealing Machine|
|8||Automatic Bottle Labelling Machine|
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|1.||CITRIC ACID||I.P.||0.200||0.200 KGS|
|2.||D – PANTHENOL||I.P.||1.000||20.00||1.200 KGS|
|3.||FERRIC AMMONIUM CITRATE||I.P.||5.900||10.00||6.490 KGS|
|4||LIQUID GLUCOSE||I.P||600.000||600.000 KGS|
|5||METHYL PARABEN SODIUM||I.P.||2.000||2.000 KGS|
|7||ORANGE FLAVOUR||I.P.||10.000||10.000 LTRS.|
|8||PROPY PARABEN SODIUM||I.P.||0.500||0.500 KGS|
|10||THIO – UREA||–||2.000||2.000 KGS|
|11||TWEEN – 80||I.P.||10.000||10.000 KGS|
|12||VITAMIN – A PALMITATE||I.P.||0.380|
|13||VITAMIN – B HCL||I.P.||0.600||67.00||1.002 KGS|
|14||VITAMIN B2 – 5 PHOSPHATE||I.P.||0.816||47.00||1.200 KGS|
|15||VITAMIN – B6 HCL||I.P.||0.400||50.00||0.600 KGS|
|16||VITAMIN – D3||I.P.||2.000||100.00||4.000 GMS|
|17.||VITAMIN – B12||I.P.||17.600|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR |
|TOTAL QUANTITY USED|
|1.||100 ML AMBER RD. BRUT BTLS||10000.000||10000.000 NOS.|
|2.||ADHESIVE TAPE ROLL||6.000||6.000 NOS|
|4||UNIT CARTONS||10000.000||2.000||10002.000 NOS|
|5||CORRUGATED BOXES B -03||238.095||238.095 NOS|
|6||GUM ACCACIA||1.000||1.000 KGS|
|7||PILFER PROOFS – 25 MM||10000.000||10000.000 NOS|
1.Average fill of each Bottle is 100 ml.
2.Volume variation limit allowed in each filled Bottle is 100 ml to 101 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 25˚ C.
Theoretical Yield is 20000 Bottles.
Expected Practical Yield is 20000 + 2% Bottles.
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 L-25 for filling and then sealing of the bottles as per its SOP.
3. Fill 100 ml syrup in amber glass brute bottle and use 25 mm PP Cap to seal the bottle mouth.
4. Inspect 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 L-26 as per its SOP.
6. Pack each filled and sealed bottle in unit carton individually.
7. Pack the 42 unit cartons in specified corrugated box B-03 to give a pack size of 42 x 100 ml.
Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
I) Preparation of Sugar Syrup:
1. Take Purified water 450 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank L-03.
2.Run the steam into the jacket so as to heat the water.
3. Add 1400 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 L-04 through transfer pump.
6.Transfer the 600 kgs Liquid Glucose to the Sugar Syrup Storage Tank and stir it vigrously 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 L-10 through transfer pump.
II) Preparation of Vitamin A and Vitamin D3 Emulsion:
1.Heat 10.0 kgs of Tween – 80 in a Stainless Steel Containers upto 600 C and transfer it to Mixer. Add 0.665 kg Vitamin A and 4.0 g of Vit. D3 to the Mixer and stir it vigoursly for half an hour.
2. Add previously heated DM water maintained at 600 C in 2:1 ratio to the mixer and stir it for 30 minutes continuously.
III) Addition of Ingredients into the Charging Tank L-10 while stirring continuously:
1.Dissolve 2.0 kgs of Methyl Paraben Sodium, 0.500 kgs of Propyl Paraben Sodium in 10 Ltrs of DM water and add to the bulk batch.
2.Dissolve 0.200 kgs of Citric Acid in 3 Ltrs of DM water and add to the bulk batch.
3.Dissolve2.0 kgs of Thiourea in 4 Ltrs of DM water and add to the bulk batch.
4.Dissolve 6.490 kgs of Ferric Ammonium Citrate in 30 Ltrs of DM water and add to the bulk batch.
5.Dissolve1.20 kgs of D – Penthenol in 5 Ltrs of DM water and add to the bulk batch.
6.Dissolve 4.60 kgs of Niacinamide in 20 Ltrs of DM water and add to the bulk batch.
7.Dissolve 1.002 kgs of Vitamin B1 HCl in 4 Ltrs of DM water and add to the bulk batch.
8.Dissolve 1.200 kgs of Vitamin B2 Phosphate in 30 Ltrs of DM water.
9.Dissolve 0.600 kgs of Vitamin B6 HCl in 3 Ltrs of DM water and add to the bulk batch.
10.Dissolve 0.800 gms of Vitamin B12 in 3 Ltrs of DM water and add to the bulk batch.
11.Dissolve 18.480 kgs of Zinc Sulphate in 40 Ltrs of DM water and add to the bulk batch.
12. Add Vitamin A Palmitate and D3 Emulsion prepared in step II to the bulk batch.
13. Add 10.0 Ltrs of Orange Flavour to the bulk batch.
14. Make up the volume with DM water and mix until homogeneous.
15. Check the pH of Solution to be in between 4.0 – 4.5.
16. Filter the batch through Filter Press L-21 by operating it as per its SOP and transfer it to the Storage Tank.
17. 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 Assistant 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 Assistant 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.
- The Assistant Manufacturing Chemist should check intermittently filled volume at 30 minutes interval 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.