MFR of Multi Vita Syrup
PURPOSE: This Master Formula Record (MFR) 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:
- 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:||BATCH SIZE: 2000 LTRS.|
|UNIT SIZE: 100 ml||PACK SIZE: 42 x 100 ML|
|DOSAGE FORM: SYRUP||EXPIRY DATE: 36 MONTHS|
|DEPARTMENT: LIQUID DEPARTMENT||STRENGTH: N.A.|
|Each 5 ml contains:|
|Vitamin B1||BP.||5 mg|
|Vitamin B12||BP||2.5 mcg|
|Vitamin B2 5 phosphate Sodium Equ.to Vitamin B2||BP||2.5 mg|
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING AS PER SOP NO.||CLEANING AS PER SOP NO.|
|1.0||Sugar Syrup Manufacturing Tank|
|2.0||Sugar Storage Tank|
|3.0||Charging Tank – V – 3500 Ltrs.|
|5.0||Storage Tank – III – 3500 Ltrs|
|6.0||Linear Bottle Washing Machine|
|7.0||Digipack Bottle Filling and Sealing Machine|
|8.0||Automatic Bottle Labelling Machine|
Raw Material Used
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|1.||CITRIC ACID||B.P.||1.600||1.600 KGS|
|2.||D – PANTHENOL||B.P.||1.000||20.00||1.200 KGS|
|3.||SODIUM BENZOATE||B.P.||10.000||10.000 KGS|
|4||LIQUID GLUCOSE||B.P||200.000||200.000 KGS|
|5||METHYL PARABEN SODIUM||B.P.||2.000||2.000 KGS|
|7||ORANGE FLAVOUR||F.G.||1.000||1.000 LTRS.|
|8||PROPY PARABEN SODIUM||B.P.||0.250||0.250 KGS|
|10||CARMOISINE COLOUR||FCF||2.000||2.000 GMS|
|11||LEMON FLAVOUR||F.G||1.000||1.000 LTRS|
|13||VITAMIN – B1 HCL||B.P.||2.00||60.00||3.200 KGS|
|14||VITAMIN B2 – 5 PHOSPHATE||BP.||1.000||56.00||1.560 KGS|
|15||VITAMIN – B6 HCL||B.P.||0.600||50.00||0.900 KGS|
|16||RASPBERRY FLAVOUR||F.G.||1.000||1.000 LTRS|
|17.||VITAMIN – B12||B.P.||1.000
Packing Material Used
PACKING MATERIAL USED:
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1.||100 ML AMBER BTLS||10000.000||10000.000 NOS.|
|2.||ADHESIVE TAPE ROLL||6.000||6.000 NOS|
|4||UNIT CARTONS||10000.000||10002.000 NOS|
|5||CORRUGATED BOXES||238.095||238.095 NOS|
|6||GUM ACCACIA||1.000||1.000 KGS|
|7||PILFER PROOFS – 25 MM||10000.000||10000.000 NOS|
Average fill of each Bottle is 100 ml.
Volume variation limit allowed in each filled Bottle is 100 ml to 101 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 25˚C.
Theoretical Yield is 20000 Bottles.
Expected Practical Yield is 20000 + 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 then sealing of the bottles as per its SOP.
Fill 100 ml syrup in amber glass brute bottle and use 25 mm PP Cap to seal the bottle mouth.
Inspect 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 SOP.
Pack each filled and sealed bottle in unit carton individually.
Pack the 42 unit cartons in specified corrugated box 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.
Preparation of Sugar Syrup:
Take Purified water 400 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank L-03.
Run the steam into the jacket so as to heat the water.
Add 1200 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 200 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.
Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank L-10 through transfer pump. .
Addition of Ingredients into the Charging Tank L-10 while stirring continuously:
Dissolve 2.0 kgs of Methyl Paraben Sodium, 0.500 kgs of Propyl Paraben Sodium in 10 Ltrs of Purified water and add to the bulk batch.
Dissolve 1.600 kgs of Citric Acid in 6 Ltrs of DM water and add to the bulk batch.
Dissolve 10.0 kgs of sodium benzoate in 30 Ltrs of DM water and add to the bulk batc
Dissolve1.20 kgs of D – Panthenol in 5 Ltrs of DM water and add to the bulk batch.
Dissolve 12.00 kgs of Niacinamide in 30 Ltrs of DM water and add to the bulk batch.
Dissolve 3.200 kgs of Vitamin B1 HCl in 10 Ltrs of DM water and add to the bulk batch.
Dissolve 1.560 kgs of Vitamin B2/5 Phosphate in 10 Ltrs of DM water.
Dissolve 0.900 kgs of Vitamin B6 HCl in 5 Ltrs of DM water and add to the bulk batch.
Dissolve 2.000 gms of carmosine colour in 1Ltrs of DM water and add to the bulk batch.
Add 1.0 Ltrs of LEMON Flavour to the bulk batch
Add 1.0 Ltrs of Orange Flavour to the bulk batch.
Add 1.0 Ltrs of pineapple Flavour to the bulk batch.
Add 1.0 Ltrs of raspberry 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 – 4.5.
Filter the batch through Filter Press L-21 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.
The 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.