MFR OF PARACETAMOL SUSPENSION
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:
- Master Copy: Manager Quality Assurance
- Copy No. 1: Production Pharmacist
- Copy No. 2: Manager Quality Control
- 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|
Each 5 ml contains:
Paracetamol I.P. 125 mg
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING|
AS PER SOP NO.
AS PER SOP NO.
|1||Charging Tank – IV – 1300 Ltrs.|
|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|
|3.||CARMOISINE COLOUR||FCF||40.000||40.000 KGS.|
|5.||CITRIC ACID||I.P||0.600||0.600 KGS.|
|7.||METHYL PARABEN (PLAIN)||I.P||2.000||2.000 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.|
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR |
|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.|
|7.||CORRUGATED BOX||231.481||231.481 NOS.|
|8.||SHRINK FILM 240X220MM||2777.777||2777.777 NOS.|
- Average fill of each Bottle is 60 ml.
- Volume variation limit allowed in each filled Bottle is 60 ml to 62 ml.
- Make up the final volume of the suspension accurately.
- Transfer the suspension 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 250 C and Relative Humidity not more than 40.
- Theoretical Yield is 33333 Bottles.
- Expected Practical Yield is 33333 + 2% Bottles.
- Wash the bottles on Linear Bottle Washing Machine L-28 and operate it as per its SOP.
- 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.
- Fill 60 ml suspension in 60 ml amber round 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 60 ml filled and sealed bottles.
- Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
- 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:
- Transfer the 600.0 kgs of invert sugar to Charging Tank through transfer pump.
- 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.
- Dissolve 2.4 kgs of Aspartum in 12 Ltrs of purified water and add to the bulk batch.
- Dissolve 2.4 kgs of Tri Potassium Citrate in 15 Ltrs of water.
- Dissolve 0.600 kgs of Citric Acid in 3 Ltrs of water.
- Dissolve 0.200 kgs of PVPK – 30 in 3 Ltrs of water.
- Add 300.0 kgs of Sorbitol Solution to the bulk batch.
- Add 52.0 kgs of Paracetamol, previously sifted through Stainless Steel mesh #40, to the bulk batch.
- Add 4.0 kgs of Aerosil to the bulk batch.
- Add previously soaked Xanthan Gum to the same charging tank.
- Add 200 Ltrs of purified water to the bulk.
- Dissolve 40.0 gms of Carmoisine colour in 3 Ltr of hot purified water and add to the bulk batch.
- Colloid the batch through Colloid Mill by operating it as per its SOP and transfer it to the Charging Tank .
- Add 6.0 Ltrs of Raspberry Flavour to the bulk.
- Add 3.2 kgs of Tween – 80 to the bulk batch.
- Add 3.2 kgs of Chloroform to the bulk batch.
- Make up the volume with purified water to 2000 Ltrs and Mix the whole batch for one hour.
- Leave the Suspension to settle for overnight or for a minimum of 8 hours.
- Again check the volume and make up with purified water to 2000 Ltrs and mix until homogeneous.
- Check the pH of Solution to be in between 5.0 – 6.0.
- Send the sample to Quality Control Department for bulk testing.
- Transfer it to the Storage Tank.
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 Assistant 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 IPQA has given the ‘Line Clearance’.