MFR OF VITATONE SYRUP
PURPOSE: This Master Formula Record 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 and cGMP Administrator 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 : cGMP Administrator
- Copy No. 4 : Liquid Section
|PRODUCT NAME: VITATONE SYRUP||BATCH SIZE: 2000 LTRS.|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 300 ml|
|GENERIC NAME: N.A.||PACK SIZE: 30 x 300 ml|
|DOSAGE FORM: SYRUP||STRENGTH: N.A.|
|DEPARTMENT: LIQUID DEPARTMENT||EXPIRY DATE: AFTER 18 MONTHS FROM THE DATE OF MANUFACTURING|
COMPOSITION: Each 15 ml contains:
|Vitamin A (as Palmitate)||I.P.||2500 I.U.|
|Vitamin D3||I.P.||200 I.U.|
|Thiamine Hydrochloride||I.P.||1.5 mg|
|Riboflavin Sodium Phosphate Iodine (as Potassium Iodide I.P.) Equ.to Riboflavin I.P. 1.7 mg||I.P.||150 mcg|
|Iron (as Ferrous Gluconate I.P.)||I.P.||9 mg|
|Pyridoxine Hydrochloride||I.P.||1.5 mg|
|Zinc (as Zinc Gluconate U.S.P.)||U.S.P.||3 mg|
|Vitamin B12||I.P.||1 mcg|
|Manganese (as Manganese Chloride U.S.P.)||U.S.P.||2.5mg|
|Vitamin C||I.P.||50 mg|
|Chromium (as Chromium Chloride U.S.P.)||U.S.P.||25 mcg|
|Vitamin E Acetate||I.P.||10 I.U.|
|Molybdenum (as Sodium Molybdate U.S.P.)||U.S.P.||25 mcg|
List Of Equipments
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING
AS PER SOP NO.
AS PER SOP NO.
|3||Charging Tank – V – 3500 Ltrs.|
|5||Storage Tank – III – 3500 Ltrs|
|6||Linear Bottle Washing Machine|
|7||Digi Pack Bottle Filling and Sealing Machine|
|8||Automatic Bottle Labelling Machine|
Raw Material Details
|S.NO.||INGREDIENTS||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|2.||ASPARTUM (P)||2.000||2.000 KGS.|
|4.||CHROMIUM CHLORIDE||17.100||15.00||19.665 GMS.|
|5.||D – PANTHENOL||0.670||20.00||0.804 KGS.|
|6.||D – BIOTIN||4.000||50.00||6.000 GMS.|
|7.||FERRIC AMMONIUM CITRATE||6.000||10.00||6.600 KGS.|
|10.||LEMON FLAVOUR||2.000||2.000 LTRS.|
|11.||LIQUID GLUCOSE||800.000||800.000 KGS.|
|12.||MANGANESE CHLORIDE||1200.000||15.00||1380.000 GMS.|
|14.||ORANGE FLAVOUR||2.000||2.000 LTRS.|
|15.||POTASSIUM IODIDE||0.026||15.00||0.030 KGS.|
|6.||PINEAPPLE FLAVOUR||2.000||2.000 LTRS.|
|17.||SODIUM BISULFITE||2.000||2.000 KGS.|
|18.||SODIUM MOLYBDATE||8.416||15.00||9.678 GMS.|
|19.||TWEEN – 80||20.000||20.000 KGS.|
|20.||VITAMIN A – PALMITATE||0.196||75.00||0.343 KGS.|
|21.||VITAMIN – B1 HCL||0.200||60.00||0.320 KGS.|
|22.||VITAMIN B2 – 5 PHOSPHATE||0.310||50.00||0.465 KGS.|
|23.||VITAMIN – B6 HCL||0.200||30.00||0.260 KGS.|
|24.||VITAMIN – D3||0.666||100.00||1.332 GMS.|
|25.||VITAMIN – B12||0.134||100.00||0.268 GMS.|
|26.||VITAMIN – C (PLAIN)||6.668||25.00||8.335 KGS.|
|27.||VITAMIN – E (ACETATE)||1.332||25.00||1.665 KGS.|
|28.||ZINC GLUCONATE||3.060||15.00||3.519 KGS.|
Packing Material Details
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1.||300 ML AMBER ROUND DANDA BTLS||6666.666||6666.666|
|2.||ADHESIVE TAPE ROLL BROWN||3.000||3.000 NOS|
|3.||CORRUGATED BOXES V – 40||222.222||222.222 NOS|
|4.||GUM ACCACIA||1.000||1.000 KGS|
|5||PILFER PROOFS – 25 MM||6666.666||6666.666 NOS|
Average fill of each Bottle is 300 ml.
Volume variation limit allowed in each filled Bottle is 300 ml to 301 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 6666 Bottles.
Expected Practical Yield is 6666 + 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 L-25 for filling and sealing of the bottles as per its SOP.
Fill 300 ml syrup in 300 ml amber glass round 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 L-26.
Pack each filled and sealed bottle in unit carton individually.
Pack the 30 unit cartons in specified corrugated box V-40 to give a pack size of 30 x 300 ml.
Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
Add 1000.0 kgs of Invert Sugar through transfer pump to the charging tank.
Add 800.0 kgs of Liquid Glucose through transfer pump to the charging tank.
Add 200.0 kgs of Glycerine through transfer pump to the charging tank.
Preparation of Vitamin A and Vitamin D3 Emulsion:
Heat 20.0 kgs of Tween – 80 in a Stainless Steel Containers upto 600 C and transfer it to Mixer. Add 0.343 kgs Vitamin A Palmitate, 1.665 kgs of Vitamin E Acetate and 1.332 gms of Vitamin D3 to the Mixer and stir it vigoursly for half an hour.
Add previously heated Purified water maintained at 600 C in 2:1 ratio to the mixer and stir it for 30 minutes continuously.
Addition of Ingredients into the Charging Tank while stirring continuously:
Dissolve 1.0 kgs of Bronopol in 10 Ltrs of Purified water and add to the bulk batch.
Dissolve 2.0 kgs of Sodium Bi Sulphite in 10 Ltrs of Purified water.
Dissolve 0.300 kgs of Aspartum in 1 Ltrs of Purified water and add to the bulk batch.
Dissolve 2.0 kgs of Aspartum (P) in 15 Ltrs of hot Purified water and add to the bulk batch.
Dissolve 3.082 kgs of Niacinamide in 15 Ltrs of Purified water and add to the bulk batch.
Dissolve 0.771 kgs of D – Penthenol in 4 Ltrs of Purified water and add to the bulk batch.
Dissolve 0.320 kgs of Vitamin B1 HCl in 1 Ltrs of Purified water and add to the bulk batch.
Dissolve 0.260 kgs of Vitamin B6 HCl in 2 Ltrs of Purified water and add to the bulk batch.
Dissolve 0.268 gms of Vitamin B12 in 2 Ltrs of Purified water and add to the bulk batch.
Dissolve 18.480 kgs of Zinc Gluconate in 100 Ltrs of Purified water and add to the bulk batch.
Dissolve 6.0 gms of D – Biotin in 3 Ltrs of hot Purified water and add to the bulk batch.
Dissolve 18.810 gms of Chromium Chloride in 3 Ltrs of hot Purified water and add to the bulk batch.
Dissolve 1320.0 gms of Manganese Chloride in 10 Ltrs of hot Purified water and add to the bulk batch.
Dissolve 0.029 kgs of Potassium Iodide in 1 Ltrs of hot Purified water and add to the bulk batch.
Dissolve 9.342 gms of Sodium Molybdate in 2 Ltrs of hot Purified water and add to the bulk batch.
Dissolve 6.6 kgs of Ferric Ammonium Citrate in 40 Ltrs of Purified water and add to the bulk batch.
Dissolve 0.434 kgs of Vitamin B2 Phosphate in 10 Ltrs of Purified water.
Dissolve 7.668 kgs of Vitamin C in 30 Ltrs of hot Purified water.
Add Vitamin A Palmitate, Vitamin E Acetate and D3 Emulsion prepared in step II to the bulk batch.
Add 2.0 Ltrs of Orange Flavour, 2.0 Ltrs of Lemon Flavour and 2.0 Ltrs of Pineapple Flavour to the bulk batch.
Make up the volume with Purified water and mix until homogeneous.
Check the pH of Solution to be in between 4.0 – 5.0.
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 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 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.