MFR OF PARACETAMOL SYRUP

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MFR OF PARACETAMOL 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 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: Liquid Section
PRODUCT NAME: PARACETAMOL SYRUP BATCH SIZE:  2000 LTRS.
PRODUCT REFERENCE CODE: UNIT SIZE:  60 ml
GENERIC NAME: PARACETAMOL SYRUP I.P. PACK SIZE:  12 x 12 x 60 ml
DOSAGE FORM: SYRUP STRENGTH: N.A.
DEPARTMENT:  LIQUID DEPARTMENT EXPIRY DATE: AFTER 24 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each 5 ml contains:

Paracetamol    I.P.        120 mg

EQUIPMENTS TO BE USED: 

SR. NO. NAME OF EQUIPMENT ASSEMBLING

AS PER SOP NO.

 CLEANING

AS PER SOP NO.
1 Charging Tank – IV – 1300 Ltrs.
2 Colloid Mill
3 Charging Tank – V – 3500 Ltrs.
4 Storage Tank – III – 3500 Ltrs
5 Linear Bottle Washing Machine
6 Linear  Bottle Filling and Sealing Machine
7 Automatic Bottle Labelling Machine
8 Shrink Packing Machine

RAW MATERIAL: –

S.NO. INGREDIENTS STD Theoretical Quantity Req. Overages % Total Quantity Used
1. PARACETAMOL    I.P 120.000 120.000 KGS.
2. ASPARTUM (POWDER) I.P 0.150 0.150 KGS.
3. CARMOISINE COLOUR FCF 100.000 100.000 GMS.
4. EDTA I.P 1.000 1.000 KGS.
5. CITRIC ACID I.P 0.600 0.600 KGS.
6. SUGAR F.G 600.000 600.000 KGS.
7. METHYL PARABEN SODIUM I.P 1.000 1.000 KGS.
8. SPIRIT CHLOROFORM I.P 35.000 35.000 LTRS.
9. P.G. I.P 180.000 180.000 KGS.
10. PROPYL PARABEN SODIUM I.P 0.250 0.250 KGS.
11. STRAWBERRY FLAVOUR F.G 1.500 1.500 LTRS.

PACKING MATERIAL:-

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. ADHESIVES TAPE ROLL BROWN 2.000 2.000 NOS.
3. GUM ACCACIA 1.000 1.000 KGS.
4. PILFER PROOFS CAPS 25 MM 16666.666 16666.666 NOS.
5. UNIT CARTON 16666.666 2.000 16668.666 NOS.
6. LABEL 16782.402 3.000 16785.402 NOS.
7. CORRUGATED BOX          115.736      115.736 NOS.
8. SHRINK FILM 240X220MM 1388.833   1388.833 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 62 ml.
  3. Make up the final volume of the suspension accurately.
  4. Transfer the suspension from charging tank L-10 to storage tank L-14 after complete charging of batch.
  5. 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.

Yield:

  1. Theoretical Yield is 16666 Bottles.
  2. 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 suspension from storage tank to Linear Bottle Filling and Sealing Machine L-29 for filling and then sealing of the bottles as per its SOP.
  3. Fill 60 ml suspension in 60 ml amber round 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.
  9. Pack such 12 shrinked packets in the Corrugated box R-09. Thus each corrugated box contains 12 x 12 x 60 ml filled and sealed bottles.
  10. 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 Purified water 200 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 600 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 L-11 while stirring continuously:      
  9. Dissolve 1.0 kgs of Methyl Paraben Sodium and 0.250 kgs of Propyl Paraben Sodium in 10.0 Ltrs of water and add to the bulk batch.
  10. Dissolve 120 kgs of Paracetamol in 180 Kgs. Of P.G and heat to mix it properly until a clear solution is prepared, then add it to the bulk batch.
  11. Dissolve 0.150 kgs of Aspartum in 5 Ltrs of Purified water and add to the bulk batch.
  12. Dissolve 1.000 kgs of EDTA in 3 Ltrs of water and add to the bulk batch.
  13. Dissolve 0.600 kgs of Citric Acid in 3 Ltrs of water.
  14. Dissolve 100.0 Gms of Carmoisine colour in 3 Ltrs of hot Purified water and add to the bulk batch.
  15. Add 1.500 Ltrs of Strawberry Flavour to the bulk.
  16. Add 35.000 Ltrs. of Spirit Chloroform to the bulk batch.
  17. Make up the volume with Purified water to 1000 Ltrs and Mix the whole batch for one hour.
  18. Check the pH of Solution to be in between 5.0 – 6.0.
  19. Send the sample to Quality Control Department for bulk testing.
  20. Transfer it to the Storage Tank.

       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. 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.
  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.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

MFR OF CLOXACILLIN SODIUM ORAL SUSPENSION USP