Kojic Acid and Vitamin C Ointment
PURPOSE: This Master formula record (MRF) 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: Ointment Section
| PRODUCT NAME: Kojic Acid and Vitamin C Ointment | BATCH SIZE: 500 KG |
| PRODUCT REFERENCE CODE: | UNIT SIZE: 20 g |
| GENERIC NAME: N.A. | PACK SIZE: 20 ´ 12 ´ 20g |
| DOSAGE FORM: OINTMENT | STRENGTH: N.A. |
| DEPARTMENT: OINTMENT DEPARTMENT | EXPIRY DATE: AFTER 18 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
| Kojic Acid | 0.75% w/w | |
| Vitamin C | I.P. | 2.5% w/w |
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING
AS PER SOP NO. |
CLEANING
AS PER SOP NO. |
| 1 | Wax Vessel | ||
| 2 | Water Vessel | ||
| 3 | Mixing Vessel | ||
| 4 | Planetary Mixer – 150 Kg | ||
| 5 | Colloidal Mill | ||
| 6 | Storage Container-I (500 Kg) | ||
| 7 | Semiautomatic Tube Filling & Sealing Machine |
Raw materials required:
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1. | CM – 1000 | I.P. | 53.000 | 53.000 KGS | |
| 2. | CETOCETYL ALCOHOL | I.P. | 78.000 | 78.000 KGS | |
| 3. | EDTA | I.P. | 0.500 | 0.500 KGS | |
| 4. | GULAB OINT. FLAVOUR | 2.500 | 2.500 LTR | ||
| 5. | GLYCERINE | I.P. | 25.000 | 25.000 KGS | |
| 6. | KOJIC ACID | 3.750 | 5.00 | 3.938 KGS | |
| 7. | LIQUID PARAFFIN LIGHT | I.P. | 37.500 | 37.500 KGS | |
| 8. | METHLY PARABEN (PLAIN) | I.P. | 0.500 | 0.500 KGS | |
| 9. | PROPYL PARABEN (PLAIN) | I.P. | 0.125 | 0.125 KGS | |
| 10. | S.M.B.S | I.P. | 1.000 | 1.000 KGS | |
| 11. | SODIUM BISULFITE | I.P. | 0.500 | 0.500 KGS | |
| 12. | VITAMIN – C (PLAIN) | I.P. | 12.500 | 30.00 | 16.250 KGS |
PACKING MATERIALS REQUIRED:
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR
RECORD |
TOTAL QUANTITY USED |
| 1. | ADHESIVE TAPE ROLL BROWN | 2.000 | 2.000 NOS | |
| 2. | CELLO TAPE | 4.000 | 4.000 NOS | |
| 3. | OUTER CARTON | 2083.000 | 2.00 | 2085.000 NOS |
| 4. | UNIT CARTON | 25000.000 | 3.000 | 25003.000 NOS |
| 5. | TUBES | 25000.000 | 25000.000 NOS | |
| 6. | CORRUGATED BOX | 104.000 | 104.000 NOS |
MANUFACTURING SPECIFICATION:
Average fill of each Tube is 20 grams.
Wight variation limit allowed in each filled Tube is + 200 mgs.
Weight Variation Limit for nominal weight of 8 filled Tubes is + 2 %.
Melt the waxes at the maintained temperature 700
Use accurate weight quantity of water to make up the final weight of cream.
Fill the Tubes and also perform the primary packing of Tubes at temperature not more than 250 C and Relative Humidity not more than 40.
Yield:
Theoretical Yield is 25000 Tubes.
Expected Practical Yield is 25000 + 2% Tube.
Packing Details:
Transfer the cream from storage tank to Semiautomatic Lami Tube Filling & Sealing Machine and start filling and then sealing of the tubes as per its SOP.
Pack the filled tubes in unit carton.
Pack such 12 tubes in each outer carton.
Seal the outer carton with cello tape.
Pack the 20 outer cartons in specified corrugated box to give a pack size of 20 x 12 x 20 Tubes.
Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS:
Melt 53.000 kgs of Ceto Macrogol- 1000, 78.000 kgs of Cetocetyl Alcohol and 37.500 kgs of Liquid Paraffin Light in a Steam Heat Wax Melting Vessel by operating it as per its SOP No. at temperature 700
Heat 282.000kgs water at 700 C in Water Vessel.
Filter and transfer the molten waxes through Stainless Steel Sieve no. 100 to the Mixer Vessel and start the machine as per its SOP.
Dissolve 0.500 kgs of E.D.T.A. in 3 kgs of water and transfer it to the bulk batch.
Dissolve 1.000 kgs of Sodium Metabisulphite in 4 kgs of water and to the bulk batch.
Dissolve 0.500 kgs of Methyl Paraben (Plain) and 0.125 kgs of Propyl Paraben (Plain) in 25.000kgs of Glycerine and transfer it to the bulk batch.
Dissolve 0.500 kgs of Sodium Bisulphite in 4 kgs of water and transfer it to the bulk batch.
Cool the batch to 450
Dissolve 3.938kgs of Kojic Acid in 15 kgs of water and transfer it to the bulk batch.
Dissolve 16.250kgs of Vitamin C (Plain) in 40kgs of water and transfer it to the bulk batch.
Add rest of the water in bulk batch.
Add 2.5 liters Gulab Ointment fragrance to the bulk batch.
Mix the whole batch for 90 minutes while running the water in the jacket.
Transfer the cream to storage tank and send the sample for bulk testing.
IN-PROCESS CONTROLS:
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.
The total weight of bulk ointment / cream should be checked in the presence of Manufacturing Chemist and record the same in Batch Manufacturing Record.
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.
While the tube filling operation is on, the Manufacturing Chemist should check weight of net filled quantity per tube at the interval of 30 minutes by checking the tare weight of empty tube and gross weight of the filled tube. Record for the same should be kept in Batch Manufacturing Record.
The ‘fill weight’ of ointment or cream per tube should not be less than the labelled amount.
Limit for Weight Variation: Weight claimed on the carton + 200 mg
Manufacturing Chemist will also ensure that the crimping of the filled Aluminium tubes, sealing of plastic tubes is appropriate and embossing of batch number and manufacturing date is conspicuous. Also the quality of embossing will be controlled by adjusting pressure exerted by the jaws, so that pinholes are not developed on the embossed letters / numbers.
The inner and outer cartons should be checked thoroughly for proper batch coding.
Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of inner cartons are being packed in each outer cartons and also the correct number of outer cartons in each shipper is exactly the same as that shown in proof.
Intimation should be sent to Quality Control Department for finished product sampling and testing.
After the completion of filling and packaging, the coded 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 be commenced only after getting the ‘Line Clearance’ of the previous product, from the Quality Control Analyst.