MFR OF CETRIZINE DIHYDROCHLORIDE SYRUP
PURPOSE: This Standard Operating Procedure 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
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:CETRIZINE DIHYDROCHLORIDE SYRUP||BATCH SIZE: 1000 LTRS.|
|PRODUCT REFERENCE CODE:||UNIT SIZE: 60 ml|
|GENERIC NAME: CETRIZINE DIHYDROCHLORIDE SYRUP||PACK SIZE: 12 x 12 x 60|
|DOSAGE FORM: SYRUP||STRENGTH: N.A.|
|DEPARTMENT: LIQUID DEPARTMENT||EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING|
Each 5 ml contains:
Cetrizine Dihydrochloride B.P. 5 mg
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 – 1000 Ltrs.|
|5||Storage Tank – 1000 Ltrs|
|6||Linear Bottle Washing Machine|
|7||Linear Bottle Filling And Sealing Machine|
|8||Automatic Bottle Labelling Machine|
|9||Shrink Packing Machine|
RAW MATERIAL DETAILS
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total Quantity Used|
|1.||CETRIZINE DI HCL||I.P.||1.000||5.00||1.050 KGS|
|2.||CITRIC ACID||I.P.||0.300||0.300 KGS|
|3.||ORANGE FLAVOUR||F.G.||2.000||2.000 LTRS|
|4.||SODIUM BENZOATE||I.P.||5.000||5.000 KGS|
|5||SORBITOL SOLUTION||I.P.||50.000||50.000 KGS|
PACKING MATERIAL DETAILS
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR
|TOTAL QUANTITY USED|
|1.||60 ML AMBER ROUND BTLS.||16666.666||16666.666 NOS.|
|2.||ADHESIVE TAPE ROLL BROWN||3.000||3.000 NOS.|
|3.||UNIT CARTON||16666.666||2.000||16668.666 NOS.|
|5.||GUM ACCACIA||1.500||1.500 KGS|
|6.||PILFER PROOFS CAPS 25MM||16666.666||16666.666 NOS.|
|7.||CORRUGATED BOX R||115.740||115.740 NOS.|
|8.||SHRINK FILM 240X220 MM||1388.888||1388.888 NOS.|
- Average fill of each Bottle is 60 ml.
- Volume variation limit allowed in each filled Bottle is 60 ml to 61 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-08 to storage tank L-12 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 16666 Bottles.
- Expected Practical Yield is 16666 + 2% Bottles.
- Wash the bottles on Linear Bottle Washing Machine L-28 and operate it as per its SOP.
- Transfer the Syrup from storage tank to Linear Bottle Filling and Sealing Machine for filling and Sealing of the bottles as per its SOP.
- Fill 60 ml syrup in amber glass 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.
- Make a group of 12 bottles packed in unit cartons.
- Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Packing Machine as per its SOP .
- Pack such 12 shrinked packets in the Corrugated box. Thus each corrugated box contains 12 x 12 x 60ml filled and sealed bottles.
- Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
- I) Preparation of Sugar Syrup:
- Take DM water 160 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank.
- Run the steam into the jacket so as to heat the water.
- Add 500 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 prepared Syrup from Sugar Syrup Storage Tank to Charging Tank through transfer pump.
- II) Addition of Ingredients into the Charging Tank while stirring continuously:
- Dissolve 5.0 kgs of Sodium Benzoate in 30 Ltrs of purified water and add to the bulk batch.
- Dissolve 0.300 kgs of Citric Acid in 5 Ltrs of purified water and add to the bulk batch.
- Add 50.0 kgs of the Sorbitol to the bulk batch.
- Dissolve 1.050 kgs of Cetrizine Di Hydrochloride in 10 Ltrs of purified water and add to the bulk batch.
- Add 2.0 Ltrs of Orange Flavour to the bulk batch.
- Make up the volume with purified water and mix for 30 minutes.
- Check the pH of Solution to be in between 4.5 – 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 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.
- Intermittently filled volume should be checked at 30 minutes intervals by the Assistant 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.