MASTER FORMULA OF KETOCONAZOLE SHAMPOO
PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE: This MFR 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 formula.
COPY ISSUED TO:
- Master Copy: Manager Quality Assurance
- Copy No. 1: Production Pharmacist
- Copy No. 2: Manager Quality Control
- Copy No. 3: Tablet Section
|PRODUCT NAME: KETOCONAZOLE SHAMPOO||BATCH SIZE: 1000 LTRS.|
|PRODUCT REFERENCE CODE: 97||UNIT SIZE: 75 ml|
|GENERIC NAME: N.A.||PACK SIZE: 12 x 12 x 75 ML|
|DOSAGE FORM: SEMI LIQUID||STRENGTH: N.A.|
|DEPARTMENT: EXTERNAL PREPARATION||EXPIRY DATE: AFTER 15 MONTHS FROM THE DATE OF MANUFACTURING|
Ketoconazole I.P. 2% w/v
EQUIPMENTS TO BE USED:
|SR. NO.||NAME OF EQUIPMENT||ASSEMBLING|
AS PER SOP NO.
AS PER SOP NO.
|1||Charging Tank – E-02(1200 Lts)|
|2||Storage Tank – III – 5000 Ltrs|
|3||Manual Bottle Filling Machine|
|4||Semi Auto Bottle Sealing Machine|
|5||Semi Auto Labelling Machine|
|6||Shrink Packing Machine|
Raw materials required:
|S.NO.||INGREDIENTS||STD||Theoretical Quantity Req.||Overages %||Total |
|1||BRILLIANT BLUE COLOUR||F.G.||32.000||32.000 GM|
|2||BASIL OIL FLAVOUR||F.G.||0.300||0.300 LTR|
|4||DRAKKAR NOIR FLAVOUR||F.G.||2.000||2.000 LTR|
|5||FORMAL DEHYDE SOLUTION||I.P.||0.800||0.800 LTR.|
|6||GLACIAL ACETIC ACID||I.P.||2.500||2.500 KGS|
|8||G – 100 (COCO MONO)||I.P.||20.000||20.000 KGS|
|10||SODIUM CHLORIDE||I.P.||10.000||10.000 KGS|
|11||SODIUM HYDROXIDE PELLET||I.P.||0.750||0.750 KGS|
PACKING MATERIALS REQUIRED:
|S.NO.||NAME OF THE MATERIAL||THEORETICAL QUANTITY REQ.||FOR |
|TOTAL QUANTITY USED|
|1||100 ml Plastic Flat Btls.||13333.000||13332.000 NOS|
|2||6 x 20 mm Flip Top Pl. Caps||13333.000||13332.000 NOS|
|3||Adhesive Tape Roll Brown||4.000||4.000 NOS|
|4||Corrugated Box||92.000||92.000 NOS|
|5||Unit Carton||13333.000||2.000||13335.000 NOS|
|6||Label – Back||13425.000||3.000||13428.000 NOS|
|7||Label – Front||13425.000||3.000||13428.000 NOS|
- Average fill of each Bottle is 75 ml.
- Volume variation limit allowed in each filled Bottle is 75 ml to 77 ml.
- Make up the final volume of the shampoo accurately.
- Transfer the shampoo from charging tank E – 02 to storage tank E-03 after complete charging of batch.
- Theoretical Yield is 13333 Bottles.
- Expected Practical Yield is 13333 + 2% Bottles.
- Transfer the Shampoo from charging tank to manual filling machine for filling of the bottles as per its SOP.
- Fill 75 ml of shampoo in white plastic flat bottle and seal every bottle with flip off top cap.
- Label every filled and closed bottle, from both front and backside, manually.
- Pack each filled and labelled 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 75 ml filled and sealed bottles.
- Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
- Add 450 kgs of S.L.E.S. in the steam jacketed charging tank .
- Add 200 kgs of Purified water to it.
- Now slowly heat at 70 oC by running the steam in the jacket of the tank.
- Add 2.5 kgs of the Glacial Acetic Acid into the tank.
- Slowly add 21 kgs of Ketoconazole under constant stirring to the bulk batch.
- Maintain the temperature at 70 0C and it should not exceed at any stage.
- Keep on mixing till baby colour is achieved and Ketoconazole is completely dissolved.
- II) Addition of Ingredients into the Charging Tank E – 02 while stirring continuously:
- Melt 30.0 kgs of C.A.P.B. in Stainless Steel Container and add to the bulk batch.
- Allow the batch to cool at 40 0C by stopping the steam supply.
- Add 20.0 kgs of G – 100 to the bulk batch.
- Add 10.0 kgs of Glycerine to the bulk batch.
- Dissolve 0.750 kgs of Sodium Hydroxide Pellets in 10 Ltrs of Purified water and add to the bulk batch.
- Add 0.800 Ltrs of Formaldehyde Solution to the bulk batch.
- Dissolve 10.0 kgs of Sodium Chloride in 25 Ltrs of D.M. water and add to the bulk batch.
- Add 0.300 Ltrs of Basil Oil Flavour and 2.0 Ltrs of Drakkar Noir Flavour to the bulk batch.
- Dissolve 32.0 Gms of Brilliant Blue colour in 3 Ltrs of hot D.M. water and add to the bulk batch.
- Stop stirring and make up the volume.
- Leave aside the batch for 24 hours so that the foaming ceases.
- After 24 hours again check the volume and make it up. Stir the batch and leave it for 12 hours.
- 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 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 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 of pH 6.0 to 7.0.
- Only after receiving the Bulk Test Report from Q.C. Dept. start filling the shampoo in bottles and seal them properly.
- The 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’.
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