MFR OF CETRIZINE DIHYDROCHLORIDE SYRUP

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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:

  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: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

COMPOSITION:

Each 5 ml contains:

Cetrizine Dihydrochloride              B.P.     5 mg

EQUIPMENTS TO BE USED:               

SR. NO. NAME OF EQUIPMENT ASSEMBLING

AS PER SOP NO.

 CLEANING

AS PER SOP NO.
1 Sugar Syrup Manufacturing Tank
2 Sugar Storage Tank
3 Charging Tank  – 1000 Ltrs.
4 Filter Press
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
6 SUGAR F.G. 500.000 500.000 KGS

 PACKING MATERIAL DETAILS 

S.NO. NAME OF THE MATERIAL THEORETICAL QUANTITY REQ. FOR

RECORD

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.
4. LABEL 16782.406 3.000 16785.406 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.

 MANUFACTURING SPECIFICATION:

  1. Average fill of each Bottle is 60 ml.
  2. Volume variation limit allowed in each filled Bottle is 60 ml to 61 ml.
  3. 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.

  1. Transfer the syrup from charging tank L-08 to storage tank L-12 after complete charging of batch.
  2. 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.
  3. Yield:
    • Theoretical Yield is 16666 Bottles.
    • Expected Practical Yield is 16666 + 2% Bottles.

Packing Details:

  1. Wash the bottles on Linear Bottle Washing Machine L-28 and operate it as per its SOP.
  2. Transfer the Syrup from storage tank to Linear Bottle Filling and Sealing Machine  for filling and Sealing of the bottles as per its SOP.
  3. Fill 60 ml syrup in amber glass bottle and use 25 mm PP Cap to seal the bottle mouth.
  4. Inspect the 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 .
  6. Pack each filled and sealed bottle in unit carton individually.
  7. Make a group of 12 bottles packed in unit cartons.
  8. Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Packing Machine  as per its SOP . 
  1. Pack such 12 shrinked packets  in the  Corrugated box.  Thus each corrugated box contains 12 x 12 x 60ml filled and sealed bottles.
  2. Seal each corrugated box with adhesive tape and label it properly by affixing the specified label. 

MANUFACTURING PROCESS:

  1. I) Preparation of Sugar Syrup:
  2. Take DM water 160 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank.
  3. Run the steam into the jacket so as to heat the water.
  4. Add 500 kgs of sugar into the tank and start stirring by operating the tank .
  5. Heat continuously till the sugar dissolves completely to give uniform Sugar Syrup.
  6. Transfer the prepared Sugar Syrup to Sugar Syrup Storage Tank  through transfer pump.
  7. Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank  through transfer pump.
  8. II) Addition of Ingredients into the Charging Tank  while stirring continuously:
  9. Dissolve 5.0 kgs of Sodium Benzoate in 30 Ltrs of purified water and add to the bulk batch.
  10. Dissolve 0.300 kgs of Citric Acid in 5 Ltrs of purified water and add to the bulk batch.
  11. Add 50.0 kgs of the Sorbitol to the bulk batch.
  12. Dissolve 1.050 kgs of Cetrizine Di Hydrochloride in 10 Ltrs of purified water and add to the bulk batch.
  13. Add 2.0 Ltrs of Orange Flavour to the bulk batch.
  14. Make up the volume with purified water and mix for 30 minutes.
  15. Check the pH of Solution to be in between 4.5 – 5.0.
  16. Filter the batch through Filter Press  by operating it as per its SOP.
  17. and transfer it to the Storage Tank .

Send the sample to Quality Control Department for bulk testing.

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. 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.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Final volume should be made as per Standard Operating Procedure using correct dipstick in the Assistant Manufacturing Chemist.
  5. pH of the bulk should be checked and it should be with in specified limits.
  6. Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
  7. 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.
  8. 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

  1. 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.
  2. Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.
  3. The labels and cartons should be checked thoroughly for proper batch coding.
  1. Intimation should be sent to Quality Control Department for finished product sampling and testing.
  2. 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.
  3. It will be ensure that filling or packaging equipment has been properly cleaned.
  4. Filling or packaging of next product should not commence until the ‘Line Clearance’ has been given by the IPQA.

MFR OF OFLOXACIN  SUSPENSION