MFR OF PARACETAMOL SUSPENSION

by

MFR OF PARACETAMOL SUSPENSION

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

COMPOSITION:

Each 5 ml contains:

Paracetamol    I.P.        125 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. AEROSIL I.P 4.000 4.000 KGS.
2. ASPARTUM I.P 2.400 2.400 KGS.
3. CARMOISINE COLOUR FCF 40.000 40.000 KGS.
4. CHLOROFORM I.P 3.200 3.200 KGS.
5. CITRIC ACID I.P 0.600 0.600 KGS.
6. SUGAR F.G 600.000 600.000 KGS.
7. METHYL PARABEN (PLAIN) I.P 2.000 2.000 KGS.
8. PARACETAMOL I.P 50.000 4.00 52.00 KGS.
9. P.G. I.P 10.000 10.000 KGS.
10. PROPYL PARABEN (PLAIN) I.P 0.400 0.400 KGS.
11. PVPK – 30 I.P 0.200 0.200 KGS.
12. RASPBERRY FLAVOUR F.G 6.000 6.000 LTRS.
13. SORBITOL SOLUTION I.P 300.000 300.000 KGS.
14. TWEEN – 80 I.P 3.200 3.200 KGS.
15. TRI POTASSIUM CITRATE I.P 2.400 2.400 KGS.
16. XANTHAN GUM I.P 6.600 6.600 KGS.

PACKING MATERIAL:-

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

RECORD

TOTAL QUANTITY USED
1. 60 ML AMBER ROUND BTLS. 33333.333 33333.333 NOS.
2. ADHESIVES TAPE ROLL BROWN 4.000 4.000 NOS.
3. GUM ACCACIA 1.500 1.500 KGS.
4. PILFER PROOFS CAPS 25 MM 33333.333 33333.333 NOS.
5. UNIT CARTON 33333.333 2.000 33335.333 NOS.
6. LABEL 33564.814 3.000 33567.814 NOS.
7. CORRUGATED BOX 231.481      231.481 NOS.
8. SHRINK FILM 240X220MM 2777.777   2777.777 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 33333 Bottles.
  2. Expected Practical Yield is 33333 + 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 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. 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. Soak 6.6 kgs of Xanthan Gum in 70 Ltrs of purified water in Stainless Steel Containers and keep it for 6 hours.

             Addition of Ingredients into the Charging Tank  while stirring continuously:      

  1. Transfer the 600.0 kgs of invert sugar to Charging Tank  through transfer pump.
  2. Dissolve 2.0 kgs of Methyl Paraben Plane and 0.400 kgs of Propyl Paraben Plane in 10 Ltrs of hot PG water and add to the bulk batch.
  3. Dissolve 2.4 kgs of Aspartum in 12 Ltrs of purified water and add to the bulk batch.
  4. Dissolve 2.4 kgs of Tri Potassium Citrate in 15 Ltrs of water.
  5. Dissolve 0.600 kgs of Citric Acid in 3 Ltrs of water.
  6. Dissolve 0.200 kgs of PVPK – 30 in 3 Ltrs of water.
  7. Add 300.0 kgs of Sorbitol Solution to the bulk batch.
  8. Add 52.0 kgs of Paracetamol, previously sifted through Stainless Steel mesh #40, to the bulk batch.
  9. Add 4.0 kgs of Aerosil to the bulk batch.
  10. Add previously soaked Xanthan Gum to the same charging tank.
  11. Add 200 Ltrs of purified water to the bulk.
  12. Dissolve 40.0 gms of Carmoisine colour in 3 Ltr of hot purified water and add to the bulk batch.
  13. Colloid the batch through Colloid Mill by operating it as per its SOP and transfer it to the Charging Tank .
  14. Add 6.0 Ltrs of Raspberry Flavour to the bulk.
  15. Add 3.2 kgs of Tween – 80 to the bulk batch.
  16. Add 3.2 kgs of Chloroform to the bulk batch.
  17. Make up the volume with purified water to 2000 Ltrs and Mix the whole batch for one hour.
  18. Leave the Suspension to settle for overnight or for a minimum of 8 hours.
  19. Again check the volume and make up with purified water to 2000 Ltrs and mix until homogeneous.
  20. Check the pH of Solution to be in between 5.0 – 6.0.
  1. Send the sample to Quality Control Department for bulk testing.
  2. 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 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.
  4. Intimation should be sent to Quality Control Department for finished product sampling and testing.
  5.  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.
  6. It will be ensure that filling or packaging equipment has been properly cleaned.
  7. Filling or packaging of next product should not commence until the IPQA  has given the ‘Line Clearance’.